Drybench Patent.
FDA Paragraph IV list: L
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with L, grouped by the NDA number the list gives.
FDA capture · review pending. Each row is shown as captured from FDA's list. Spreadsheet day numbers are shown as dates; a cell that cannot be read as one date is shown as written. A row is placed under an NDA only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads the list has not been independently reviewed by a regulatory-affairs reviewer.
- Paragraph IV list captured
- 17 October 2026
- Last checked
- 30 October 2026
Rows as FDA lists them, not a forecast of market entry and not legal, regulatory or investment advice.
FDA's list is not complete and names no ANDA applicant, patent number or litigation. A product not shown here may still have had a Paragraph IV certification submitted; a product shown under an NDA may have more rows among those kept apart.
The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.
Lacosamide
NDA 022253 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 50 mg, 100 mg, 150 mg, and 200 mg
RLD/NDA as listed: Vimpat 22253- First PIV submission
- 29 Oct 2012
- ANDAs
- 14
- 180-day status
- Extinguished
- Decision posted
- 18 Apr 2022
- First applicant approval
- 17 Mar 2022
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 17 Mar 2022
Lacosamide
NDA 022254 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 10 mg/mL, 20 mL
RLD/NDA as listed: Vimpat 22254- First PIV submission
- 30 Jun 2016
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 10 Mar 2020
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 17 Mar 2022
Lacosamide
NDA 022255 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 10 mg/mL
RLD/NDA as listed: Vimpat 22255- First PIV submission
- 29 Oct 2012
- ANDAs
- 3
- 180-day status
- Extinguished
- Decision posted
- 18 Apr 2022
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 17 Mar 2022
Lacosamide
NDA 216185 · 2 rows · Listed patents and exclusivities · Open in the app
Extended-release Capsules · 100 mg and 150 mg
RLD/NDA as listed: Motpoly XR 216185- First PIV submission
- 10 Feb 2026
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 5 Jun 2040
Extended-release Capsules · 200 mg
RLD/NDA as listed: Motpoly XR 216185- First PIV submission
- 29 Dec 2025
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 5 Jun 2040
Lactic Acid, Citric Acid and Potassium Bitartrate
NDA 208352 · 1 row · Listed patents and exclusivities · Open in the app
Vaginal Gel · 1.8%/1%/0.4%
RLD/NDA as listed: Phexxi 208352- First PIV submission
- 28 Feb 2023
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 8 Jul 2024
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 15 Mar 2033
Lactulose
NDA 017657 · 1 row · Listed patents and exclusivities · Open in the app
Oral Syrup · 10 g/15 mL
RLD/NDA as listed: Cephulac 17657- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Lactulose
NDA 017884 · 1 row · Listed patents and exclusivities · Open in the app
Oral Syrup · 10 g/15 mL
RLD/NDA as listed: Chronulac 17884- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Lamotrigine
NDA 020241 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 25 mg, 100 mg, 150 mg and 200 mg
RLD/NDA as listed: Lamictal 20241- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Lamotrigine
NDA 020764 · 1 row · Listed patents and exclusivities · Open in the app
Chewable Tablets · 2 mg, 5 mg and 25 mg
RLD/NDA as listed: Lamictal CD 20764- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Lamotrigine
NDA 022115 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg
RLD/NDA as listed: Lamictal XR 22115- First PIV submission
- 12 Feb 2014
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 7 Apr 2020
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 14 Jun 2028
Lamotrigine
NDA 022251 · 1 row · Listed patents and exclusivities · Open in the app
Orally Disintegrating Tablets · 25 mg, 50 mg, 100 mg, and 200 mg
RLD/NDA as listed: Lamictal ODT 22251- First PIV submission
- 21 Dec 2009
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 5 Oct 2021
- First applicant approval
- 15 Jul 2013
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 4 Jan 2029
Lansoprazole
NDA 020406 · 1 row · Listed patents and exclusivities · Open in the app
Delayed-release Pellets/Capsules · 15 mg and 30 mg
RLD/NDA as listed: Prevacid 20406- First PIV submission
- 5 Dec 2005
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Lansoprazole
NDA 021428 · 1 row · Listed patents and exclusivities · Open in the app
Delayed-release Orally Disintegrating Tablets · 15 mg and 30 mg
RLD/NDA as listed: Prevacid 21428- First PIV submission
- 27 Dec 2006
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 5 Oct 2021
- First applicant approval
- 15 Oct 2010
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 10 May 2009
Lanthanum Carbonate
NDA 021468 · 1 row · Listed patents and exclusivities · Open in the app
Chewable Tablet · 500 mg, 750 mg and 1000 mg
RLD/NDA as listed: Fosrenol 21468- First PIV submission
- 27 Oct 2008
- ANDAs
- 3
- 180-day status
- Deferred
- Decision posted
- 16 Jul 2019
- First applicant approval
- 11 Aug 2017
- First marketing
- 30 Aug 2017
- Last qualifying patent expiry (as listed by FDA)
- 26 Aug 2024
Lanthanum Carbonate
NDA 204734 · 1 row · Listed patents and exclusivities · Open in the app
Oral Powder · 750 mg and 1000 mg
RLD/NDA as listed: Fosrenol 204734- First PIV submission
- 25 Nov 2015
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 15 Jun 2020
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 1 Dec 2030
Lapatinib Ditosylate
NDA 022059 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 250 mg
RLD/NDA as listed: Tykerb 22059- First PIV submission
- 14 Mar 2011
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 17 Nov 2020
- First applicant approval
- 29 Sep 2020
- First marketing
- 29 Sep 2020
- Last qualifying patent expiry (as listed by FDA)
- 19 Nov 2021
Larotrectinib Sulfate
NDA 210861 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 25 mg and 100 mg
RLD/NDA as listed: Vitrakvi 210861- First PIV submission
- 6 May 2025
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 16 May 2037
Lasmiditan Succinate
NDA 211280 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 50 mg and 100 mg
RLD/NDA as listed: Reyvow 211280- First PIV submission
- 31 Jan 2024
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 5 Dec 2037
Latanoprost
NDA 020597 · 1 row · Listed patents and exclusivities · Open in the app
Ophthalmic Solution · 0.005%
RLD/NDA as listed: Xalatan 20597- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Latanoprost and Netarsudil Dimesylate
NDA 208259 · 1 row · Listed patents and exclusivities · Open in the app
Ophthalmic Solution · 0.005%/0.02%
RLD/NDA as listed: Rocklatan 208259- First PIV submission
- 20 Dec 2021
- ANDAs
- 2
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 14 Mar 2034
Latanoprostene Bunod
NDA 207795 · 1 row · Listed patents and exclusivities · Open in the app
Ophthalmic Solution · 2.4000000000000001E-4
RLD/NDA as listed: Vyzulta 207795- First PIV submission
- 31 Mar 2022
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 12 May 2025
- First applicant approval
- 29 Apr 2025
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 21 Feb 2029
Lemborexant
NDA 212028 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 5 mg
RLD/NDA as listed: Dayvigo 212028- First PIV submission
- 14 Jul 2026
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 21 Oct 2035
Lenalidomide
NDA 021880 · 3 rows · Listed patents and exclusivities · Open in the app
Capsules · 2.5 mg and 20 mg
RLD/NDA as listed: Revlimid 21880- First PIV submission
- 12 Jul 2016
- ANDAs
- 1
- 180-day status
- Non-Forfeiture
- Decision posted
- 17 Nov 2020
- First applicant approval
- 14 Oct 2021
- First marketing
- 7 Sep 2022
- Last qualifying patent expiry (as listed by FDA)
- 27 Apr 2027
Capsules · 25 mg
RLD/NDA as listed: Revlimid 21880- First PIV submission
- 12 Jul 2010
- ANDAs
- 1
- 180-day status
- Non-Forfeiture
- Decision posted
- 17 Nov 2020
- First applicant approval
- 21 May 2021
- First marketing
- 3 Mar 2022
- Last qualifying patent expiry (as listed by FDA)
- 27 Apr 2027
Capsules · 5 mg, 10 mg and 15 mg
RLD/NDA as listed: Revlimid 21880- First PIV submission
- 30 Aug 2010
- ANDAs
- 1
- 180-day status
- Non-Forfeiture
- Decision posted
- 17 Nov 2020
- First applicant approval
- 21 May 2021
- First marketing
- 3 Mar 2022
- Last qualifying patent expiry (as listed by FDA)
- 27 Apr 2027
Lenvatinib
NDA 206947 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 4 mg and 10 mg
RLD/NDA as listed: Lenvima 206947- First PIV submission
- 13 Feb 2019
- ANDAs
- 2
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 27 Jul 2027
Letermovir
NDA 209939 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 240 mg and 480 mg
RLD/NDA as listed: Prevymis 209939- First PIV submission
- 16 Oct 2024
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 18 Jan 2029
Letermovir
NDA 209940 · 1 row · Listed patents and exclusivities · Open in the app
Intravenous Solution · 240 mg/12 mL and 480 mg/24 mL
RLD/NDA as listed: Prevymis 209940- First PIV submission
- 26 Mar 2026
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 28 Feb 2033
Letrozole
NDA 020726 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 2.5 mg
RLD/NDA as listed: Femara 20726- First PIV submission
- 2 Mar 2006
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 6 Apr 2021
- First applicant approval
- 24 Dec 2008
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 3 Jun 2011
Leuprolide Acetate
NDA 019732 · 1 row · Listed patents and exclusivities · Open in the app
Injection (depot) · 7.5 mg/vial
RLD/NDA as listed: Lupron Depot 19732- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Levalbuterol Hydrochloride
NDA 020837 · 2 rows · Listed patents and exclusivities · Open in the app
Inhalation Solution · 0.0103%, 0.021% and 0.042%
RLD/NDA as listed: Xopenex 20837- First PIV submission
- 20 Jun 2005
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 5 Oct 2021
- First applicant approval
- 9 Apr 2008
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 21 Mar 2021
Inhalation Solution · 0.25%
RLD/NDA as listed: Xopenex 20837- First PIV submission
- 23 May 2006
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 5 Oct 2021
- First applicant approval
- 20 Mar 2009
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 21 Mar 2021
Levalbuterol Tartrate
NDA 021730 · 1 row · Listed patents and exclusivities · Open in the app
Inhalation Aerosol · 0.045 mg/actuation
RLD/NDA as listed: Xopenex HFA 21730- First PIV submission
- 27 Feb 2012
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 10 Mar 2020
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 8 Oct 2024
Levetiracetam
NDA 021035 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 1000 mg
RLD/NDA as listed: Keppra 21035- First PIV submission
- 24 Jan 2007
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- 15 Jan 2009
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 14 Jul 2008
Tablets · 250 mg, 500 mg and 750 mg
RLD/NDA as listed: Keppra 21035- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Levetiracetam
NDA 022285 · 2 rows · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 1000 mg
RLD/NDA as listed: Keppra XR 22285- First PIV submission
- 7 Jan 2011
- ANDAs
- 2
- 180-day status
- Extinguished
- Decision posted
- 10 Mar 2020
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 17 Sep 2028
Extended-release Tablets · 500 mg and 750 mg
RLD/NDA as listed: Keppra XR 22285- First PIV submission
- 7 Jan 2011
- ANDAs
- 3
- 180-day status
- Eligible
- Decision posted
- 15 Jun 2020
- First applicant approval
- 12 Sep 2011
- First marketing
- 12 Sep 2011
- Last qualifying patent expiry (as listed by FDA)
- 17 Sep 2028
Levocetirizine Dihydrochloride
NDA 022064 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 5 mg
RLD/NDA as listed: Xyzal 22064- First PIV submission
- 17 Dec 2007
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 5 Oct 2021
- First applicant approval
- 26 Nov 2010
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 24 Sep 2012
Levocetirizine Dihydrochloride
NDA 022157 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 0.5 mg/mL
RLD/NDA as listed: Xyzal 22157- First PIV submission
- 14 Jan 2009
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 5 Oct 2021
- First applicant approval
- 7 Nov 2011
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 24 Sep 2012
Levocetirizine Dihydrochloride
NDA 209090 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 0.5 mg/mL
RLD/NDA as listed: Xyzal Allergy 24 HR (OTC) 209090- First PIV submission
- 4 Jan 2018
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 5 Oct 2021
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Levofloxacin
NDA 020634 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 250 mg, 500 mg and 750 mg
RLD/NDA as listed: Levaquin 20634- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Levofloxacin
NDA 020635 · 2 rows · Listed patents and exclusivities · Open in the app
Injection · 25 mg/mL
RLD/NDA as listed: Levaquin 20635- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Injection · 5 mg/mL; 50 mL, 100 mL and 150 mL vials
RLD/NDA as listed: Levaquin in Dextrose 5% in Plastic Container 20635- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Levofloxacin
NDA 021199 · 1 row · Listed patents and exclusivities · Open in the app
Ophthalmic Solution · 0.5%
RLD/NDA as listed: Quixin 21199- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Levofloxacin
NDA 021721 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 25 mg/mL
RLD/NDA as listed: Levaquin 21721- First PIV submission
- 30 Jul 2009
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 5 Oct 2021
- First applicant approval
- 20 Jun 2011
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 26 Feb 2022
Levoketoconazole
NDA 214133 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 150 mg
RLD/NDA as listed: Recorlev 214133- First PIV submission
- 30 Dec 2025
- ANDAs
- 4
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 20 Mar 2040
Levoleucovorin Calcium
NDA 020140 · 2 rows · Listed patents and exclusivities · Open in the app
Injection · 10 mg/mL, 17.5 mL vial and 25 mL vial
RLD/NDA as listed: Fusilev 20140- First PIV submission
- 26 Oct 2011
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 5 Oct 2021
- First applicant approval
- 9 Mar 2015
- First marketing
- 23 Apr 2015
- Last qualifying patent expiry (as listed by FDA)
- 31 Dec 2019
Injection · 50 mg/vial
RLD/NDA as listed: Fusilev 20140- First PIV submission
- 19 Dec 2013
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Levomilnacipran
NDA 204168 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Capsules · 20 mg, 40 mg, 80 mg and 120 mg
RLD/NDA as listed: Fetzima 204168- First PIV submission
- 25 Jul 2017
- ANDAs
- 6
- 180-day status
- Eligible
- Decision posted
- 19 May 2020
- First applicant approval
- 4 Feb 2019
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 2 Mar 2031
Levonorgestrel and Ethinyl Estradiol
NDA 021544 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 0.15 mg/0.03 mg
RLD/NDA as listed: Seasonale 21544- First PIV submission
- 29 Mar 2004
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 14 Oct 2024
- First applicant approval
- 6 Sep 2006
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Levonorgestrel and Ethinyl Estradiol
NDA 021864 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 0.09 mg/0.02 mg
RLD/NDA as listed: Lybrel 21864- First PIV submission
- 5 Oct 2007
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 5 Oct 2021
- First applicant approval
- 6 Jun 2011
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 3 Sep 2018
Levonorgestrel and Ethinyl Estradiol
NDA 208612 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 0.1 mg/0.02 mg
RLD/NDA as listed: Balcoltra 208612- First PIV submission
- 14 Jul 2020
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 1 May 2023
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 16 Aug 2021
Levonorgestrel; Ethinyl Estradiol; Ethinyl Estradiol
NDA 021840 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 0.15 mg/0.03 mg/0.01 mg
RLD/NDA as listed: Seasonique 21840- First PIV submission
- 22 Jan 2008
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 14 Oct 2024
- First applicant approval
- 31 May 2011
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 30 Jan 2024
Levonorgestrel; Ethinyl Estradiol; Ethinyl Estradiol
NDA 022262 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 0.1 mg/0.02 mg and 0.01 mg
RLD/NDA as listed: LoSeasonique 22262- First PIV submission
- 16 Nov 2009
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 5 Oct 2021
- First applicant approval
- 26 Oct 2011
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 15 Jun 2023
Levonorgestrel; Ethinyl Estradiol;Ethinyl Estradiol
NDA 204061 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg and 0.01 mg
RLD/NDA as listed: Quartette 204061- First PIV submission
- 10 Jul 2013
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 5 Oct 2021
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Levothyroxine Sodium
NDA 021301 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.1 mg, 0.112 mg, 0.125 mg, 0.150 mg, 0.175 mg, 0.2 mg and 0.3 mg
RLD/NDA as listed: Levoxyl 21301- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Levothyroxine Sodium
NDA 021924 · 5 rows · Listed patents and exclusivities · Open in the app
Capsules · 112 mcg
RLD/NDA as listed: Tirosint 21924- First PIV submission
- 18 Dec 2020
- ANDAs
- 1
- 180-day status
- Extinguished Deferred
- Decision posted
- 3/18/2024 7/25/2022
- First applicant approval
- 16 Apr 2021
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 14 Mar 2024
Capsules · 137 mcg and 175 mcg
RLD/NDA as listed: Tirosint 21924- First PIV submission
- 4 Nov 2022
- ANDAs
- 1
- 180-day status
- Extinguished Deferred
- Decision posted
- 3/18/2024 5/1/2023
- First applicant approval
- 2 May 2023
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 14 Mar 2024
Capsules · 200 mcg
RLD/NDA as listed: Tirosint 21924- First PIV submission
- 30 Dec 2021
- ANDAs
- 1
- 180-day status
- Extinguished Deferred
- Decision posted
- 3/18/2024 11/15/2022
- First applicant approval
- 9 Nov 2022
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 14 Mar 2024
Capsules · 75 mcg and 150 mcg
RLD/NDA as listed: Tirosint 21924- First PIV submission
- 29 Dec 2017
- ANDAs
- 1
- 180-day status
- Extinguished Deferred
- Decision posted
- 3/18/2024 1/12/2021
- First applicant approval
- 28 Oct 2020
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 14 Mar 2024
Capsules · 88 mcg, 100 mcg and 125 mcg
RLD/NDA as listed: Tirosint 21924- First PIV submission
- 1 Aug 2019
- ANDAs
- 1
- 180-day status
- Extinguished Deferred
- Decision posted
- 3/18/2024 1/12/2021
- First applicant approval
- 6 Jan 2021
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 14 Mar 2024
Levothyroxine Sodium
NDA 202231 · 2 rows · Listed patents and exclusivities · Open in the app
for Injection · 100 mcg/vial and 500 mcg/vial
RLD/NDA as listed: Levothyroxine Sodium 202231- First PIV submission
- 14 Apr 2015
- ANDAs
- 2
- 180-day status
- Eligible
- Decision posted
- 18 Jun 2019
- First applicant approval
- 29 Jun 2016
- First marketing
- 2 Apr 2018
- Last qualifying patent expiry (as listed by FDA)
- 3 Oct 2032
for Injection · 200 mcg/vial
RLD/NDA as listed: Levothyroxine Sodium 202231- First PIV submission
- 1 May 2015
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 18 Jun 2019
- First applicant approval
- 7 Dec 2015
- First marketing
- 5 Jul 2016
- Last qualifying patent expiry (as listed by FDA)
- 3 Oct 2032
Levothyroxine Sodium
NDA 206977 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 13 mcg/mL 25 mcg/mL 50 mcg/mL 75 mcg/mL 88 mcg/mL 100 mcg/mL 112 mcg/mL 125 mcg/mL 137 mcg/mL 150 mcg/mL 175 mcg/mL 200 mcg/mL
RLD/NDA as listed: Tirosint-Sol 206977- First PIV submission
- 30 Sep 2022
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 28 Feb 2037
Levothyroxine Sodium
NDA 214047 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 100 mcg/5 mL
RLD/NDA as listed: Thyquidity 214047- First PIV submission
- 28 Dec 2022
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 9 Jun 2025
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 6 Aug 2031
Lidocaine
NDA 020612 · 1 row · Listed patents and exclusivities · Open in the app
Topical Patch · 5%
RLD/NDA as listed: Lidoderm 20612- First PIV submission
- 13 Nov 2009
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 5 Oct 2021
- First applicant approval
- 23 Aug 2012
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 27 Oct 2015
Lidocaine
NDA 207962 · 1 row · Listed patents and exclusivities · Open in the app
Topical Patch · 1.7999999999999999E-2
RLD/NDA as listed: Ztlido 207962- First PIV submission
- 17 Mar 2022
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 14 Apr 2025
- First applicant approval
- 25 Mar 2025
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 10 May 2031
Lifitegrast
NDA 208073 · 1 row · Listed patents and exclusivities · Open in the app
Ophthalmic Solution · 0.05
RLD/NDA as listed: Xiidra 208073- First PIV submission
- 13 Jul 2020
- ANDAs
- 4
- 180-day status
- Eligible
- Decision posted
- 7 Aug 2023
- First applicant approval
- 4 Aug 2023
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 25 Jul 2033
Linaclotide
NDA 202811 · 2 rows · Listed patents and exclusivities · Open in the app
Capsules · 145 mcg and 290 mcg
RLD/NDA as listed: Linzess 202811- First PIV submission
- 30 Aug 2016
- ANDAs
- 4
- 180-day status
- Deferred
- Decision posted
- 22 Feb 2021
- First applicant approval
- 9 Feb 2021
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 30 Oct 2031
Capsules · 72 mcg
RLD/NDA as listed: Linzess 202811- First PIV submission
- 7 Nov 2017
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 28 Sep 2026
- First applicant approval
- 24 Sep 2026
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 16 Aug 2033
Linagliptin
NDA 201280 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 5 mg
RLD/NDA as listed: Tradjenta 201280- First PIV submission
- 4 May 2015
- ANDAs
- 11
- 180-day status
- Non-Forfeiture Eligible
- Decision posted
- 7/15/2026 12/14/2021
- First applicant approval
- 31 Aug 2021
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 5 Mar 2031
Linagliptin and Metformin Hydrochloride
NDA 201281 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 2.5 mg/500 mg 2.5 mg/850 mg 2.5 mg/1000 mg
RLD/NDA as listed: Jentadueto 201281- First PIV submission
- 4 May 2015
- ANDAs
- 8
- 180-day status
- Eligible
- Decision posted
- 7 Sep 2021
- First applicant approval
- 30 Aug 2021
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 4 Jun 2030
Linagliptin and Metformin Hydrochloride
NDA 208026 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 2.5 mg/1000 mg 5 mg/1000 mg
RLD/NDA as listed: Jentadueto XR 208026- First PIV submission
- 28 Mar 2018
- ANDAs
- 1
- 180-day status
- Non-Forfeiture
- Decision posted
- 17 Aug 2026
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 21 May 2030
Linezolid
NDA 021130 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 600 mg
RLD/NDA as listed: Zyvox 21130- First PIV submission
- 21 Dec 2005
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 5 Oct 2021
- First applicant approval
- 18 May 2015
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 18 Nov 2014
Linezolid
NDA 021131 · 2 rows · Listed patents and exclusivities · Open in the app
Injection · 2 mg/mL, 100 mL bag
RLD/NDA as listed: Zyvox 21131- First PIV submission
- 29 Dec 2009
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 5 Oct 2021
- First applicant approval
- 16 Jul 2015
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 18 Nov 2014
Injection · 2 mg/mL, 300 mL bag
RLD/NDA as listed: Zyvox 21131- First PIV submission
- 1 Sep 2009
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 5 Oct 2021
- First applicant approval
- 27 Jun 2012
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 18 Nov 2014
Linezolid
NDA 021132 · 1 row · Listed patents and exclusivities · Open in the app
Oral Suspension · 100 mg/5 mL
RLD/NDA as listed: Zyvox 21132- First PIV submission
- 3 Aug 2009
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 15 Nov 2022
- First applicant approval
- 3 Jun 2015
- First marketing
- 18 Nov 2015
- Last qualifying patent expiry (as listed by FDA)
- 29 Jan 2021
Liraglutide
NDA 022341 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 18 mg/3 mL prefilled syringe
RLD/NDA as listed: Victoza 22341- First PIV submission
- 12 Dec 2016
- ANDAs
- 1
- 180-day status
- Non-Forfeiture
- Decision posted
- 8 Jul 2024
- First applicant approval
- blank
- First marketing
- 24 Jun 2024
- Last qualifying patent expiry (as listed by FDA)
- 23 Sep 2032
Liraglutide
NDA 206321 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 18 mg/3 mL prefilled syringe
RLD/NDA as listed: Saxenda 206321- First PIV submission
- 16 Aug 2021
- ANDAs
- 1
- 180-day status
- Non-Forfeiture Deferred
- Decision posted
- 9/29/2025 9/29/2025
- First applicant approval
- 27 Aug 2025
- First marketing
- 28 Aug 2025
- Last qualifying patent expiry (as listed by FDA)
- 9 Jan 2037
Lisdexamfetamine Dimesylate
NDA 021977 · 2 rows · Listed patents and exclusivities · Open in the app
Capsules · 10 mg
RLD/NDA as listed: Vyvanse 21977- First PIV submission
- 9 Apr 2020
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 18 Apr 2023
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 24 Feb 2023
Capsules · 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg
RLD/NDA as listed: Vyvanse 21977- First PIV submission
- 23 Feb 2011
- ANDAs
- 6
- 180-day status
- Extinguished
- Decision posted
- 18 Apr 2023
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 24 Feb 2023
Lisinopril
NDA 208401 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 1 mg/mL
RLD/NDA as listed: Qbrelis 208401- First PIV submission
- 24 Oct 2019
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 15 Jun 2021
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 6 Nov 2035
Loperamide Hydrochloride and Simethicone
NDA 020606 · 1 row · Listed patents and exclusivities · Open in the app
Chewable Tablets · 2 mg/125 mg
RLD/NDA as listed: Imodium Multi-Symptom Relief 20606- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Loperamide Hydrochloride and Simethicone
NDA 021140 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 2 mg/125 mg
RLD/NDA as listed: Imodium Multi-Symptom Relief 21140- First PIV submission
- 29 Dec 2004
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Lopinavir and Ritonavir
NDA 021251 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 80 mg/20 mg per mL
RLD/NDA as listed: Kaletra 21251- First PIV submission
- 19 Jun 2014
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 11 Feb 2020
- First applicant approval
- 27 Dec 2016
- First marketing
- 23 Jan 2017
- Last qualifying patent expiry (as listed by FDA)
- 28 Nov 2021
Lopinavir and Ritonavir
NDA 021906 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 100 mg/25 mg and 200 mg/50 mg
RLD/NDA as listed: Kaletra 21906- First PIV submission
- 23 Dec 2008
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 15 Jun 2020
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 10 Nov 2020
Loratadine
NDA 019658 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 10 mg
RLD/NDA as listed: Claritin 19658- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Loratadine
NDA 020641 · 1 row · Listed patents and exclusivities · Open in the app
Syrup · 1 mg/mL
RLD/NDA as listed: Claritin 20641- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Loratadine
NDA 020704 · 1 row · Listed patents and exclusivities · Open in the app
Orally Disintegrating Tablets · 10 mg
RLD/NDA as listed: Claritin RediTabs 20704- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Loratadine/ Pseudoephedrine
NDA 019670 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 5 mg/120 mg
RLD/NDA as listed: Claritin D- 12 hour 19670- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Loratadine/ Pseudoephedrine
NDA 020470 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 10 mg/240 mg
RLD/NDA as listed: Claritin D- 24 hour 20470- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Lorlatinib
NDA 210868 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 25 mg and 100 mg
RLD/NDA as listed: Lorbrena 210868- First PIV submission
- 23 Jun 2026
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 4 Oct 2038
Losartan Potassium
NDA 020386 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 25 mg, 50 mg, and 100 mg
RLD/NDA as listed: Cozaar 20386- First PIV submission
- Pre-MMA
- ANDAs
- blank
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Losartan Potassium and Hydrochlorothiazide
NDA 020387 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 100 mg/12.5 mg
RLD/NDA as listed: Hyzaar 20387- First PIV submission
- 4 Apr 2006
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- blank
Tablets · 50 mg/12.5 mg and 100 mg/25 mg
RLD/NDA as listed: Hyzaar 20387- First PIV submission
- 24 May 2004
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 5 Oct 2021
- First applicant approval
- 6 Apr 2010
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 4 Sep 2009
Loteprednol Etabonate
NDA 208219 · 1 row · Listed patents and exclusivities · Open in the app
Ophthalmic Gel · 3.8E-3
RLD/NDA as listed: Lotemax SM 208219- First PIV submission
- 14 Nov 2022
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 7 Jul 2025
- First applicant approval
- 30 Jun 2025
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 23 Dec 2036
Lubiprostone
NDA 021908 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 8 mcg and 24 mcg
RLD/NDA as listed: Amitiza 21908- First PIV submission
- 20 Aug 2012
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 30 Nov 2021
- First applicant approval
- 27 Jun 2022
- First marketing
- 4 Jan 2021
- Last qualifying patent expiry (as listed by FDA)
- 30 Aug 2022
Lumateperone Tosylate
NDA 209500 · 2 rows · Listed patents and exclusivities · Open in the app
Capsules · 10.5 mg and 21 mg
RLD/NDA as listed: Caplyta 209500- First PIV submission
- 20 Dec 2023
- ANDAs
- 6
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 10 Dec 2040
Capsules · 42 mg
RLD/NDA as listed: Caplyta 209500- First PIV submission
- 20 Dec 2023
- ANDAs
- 7
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 10 Dec 2040
Lurasidone Hydrochloride
NDA 200603 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg
RLD/NDA as listed: Latuda 200603- First PIV submission
- 28 Oct 2014
- ANDAs
- 14
- 180-day status
- Extinguished Eligible
- Decision posted
- 1/12/2021 8/27/2019
- First applicant approval
- 3 Jan 2019
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 26 May 2026
Lurbinectedin
NDA 213702 · 1 row · Listed patents and exclusivities · Open in the app
Powder for Injection · 4 mg/vial
RLD/NDA as listed: Zepzelca 213702- First PIV submission
- 17 Jun 2024
- ANDAs
- 5
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 13 Dec 2029
Lutetium Lu 177 Dotatate
NDA 208700 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 10 mCi/mL
RLD/NDA as listed: Lutathera 208700- First PIV submission
- 13 Nov 2023
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 25 Jul 2038