Drybench Patent.
FDA Paragraph IV list: V
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with V, 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.
Valacyclovir Hydrochloride
NDA 020487 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 500 mg and 1000 mg
RLD/NDA as listed: Valtrex 20487- 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
Valbenazine Tosylate
NDA 209241 · 2 rows · Listed patents and exclusivities · Open in the app
Capsules · 40 mg and 80 mg
RLD/NDA as listed: Ingrezza 209241- First PIV submission
- 12 Apr 2021
- ANDAs
- 4
- 180-day status
- Eligible
- Decision posted
- 15 Apr 2024
- First applicant approval
- 5 Apr 2024
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 10 Aug 2040
Capsules · 60 mg
RLD/NDA as listed: Ingrezza 209241- First PIV submission
- 14 Feb 2022
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 19 Aug 2024
- First applicant approval
- 7 Aug 2024
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 10 Aug 2040
Valbenazine Tosylate
NDA 218390 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 40 mg, 60 mg and 80 mg
RLD/NDA as listed: Ingrezza Sprinkle 218390- First PIV submission
- 7 Jan 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)
- 10 Aug 2040
Valganciclovir Hydrochloride
NDA 021304 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 450 mg
RLD/NDA as listed: Valcyte 21304- First PIV submission
- 27 Dec 2005
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 27 Jul 2020
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 28 Jul 2014
Valganciclovir Hydrochloride
NDA 022257 · 1 row · Listed patents and exclusivities · Open in the app
for Oral Solution · 50 mg/mL
RLD/NDA as listed: Valcyte 22257- First PIV submission
- 21 Mar 2011
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 2 Jan 2020
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 29 Mar 2015
Valsartan
NDA 021283 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 40 mg, 80 mg, 160 mg and 320 mg
RLD/NDA as listed: Diovan 21283- First PIV submission
- 28 Dec 2004
- ANDAs
- 1
- 180-day status
- Non-Forfeiture
- Decision posted
- 27 Jul 2020
- First applicant approval
- 26 Jun 2014
- First marketing
- 7 Jul 2014
- Last qualifying patent expiry (as listed by FDA)
- 18 Jun 2017
Valsartan and Hydrochlorothiazide
NDA 020818 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 320 mg/12.5 mg and 320 mg/25 mg
RLD/NDA as listed: Diovan HCT 20818- First PIV submission
- 7 Feb 2007
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 27 Jul 2020
- First applicant approval
- 21 Sep 2012
- First marketing
- 21 Sep 2012
- Last qualifying patent expiry (as listed by FDA)
- 18 Jun 2017
Tablets · 80 mg/12.5 mg 160 mg/12.5 mg 160 mg/25 mg
RLD/NDA as listed: Diovan HCT 20818- First PIV submission
- 2 Dec 2005
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 27 Jul 2020
- First applicant approval
- 21 Sep 2012
- First marketing
- 21 Sep 2012
- Last qualifying patent expiry (as listed by FDA)
- 18 Jun 2017
Vancomycin Hydrochloride
NDA 208910 · 1 row · Listed patents and exclusivities · Open in the app
For Oral Solution · 25 mg/mL and 50 mg/mL
RLD/NDA as listed: Firvanq Kit 208910- First PIV submission
- 18 May 2020
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 13 Dec 2022
- First applicant approval
- 14 Nov 2022
- First marketing
- 29 Aug 2023
- Last qualifying patent expiry (as listed by FDA)
- 13 Mar 2035
Vardenafil Hydrochloride
NDA 021400 · 3 rows · Listed patents and exclusivities · Open in the app
Tablets · 2.5 mg
RLD/NDA as listed: Levitra 21400- First PIV submission
- 4 Sep 2009
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 27 Jul 2020
- First applicant approval
- 3 May 2012
- First marketing
- 3 Oct 2018
- Last qualifying patent expiry (as listed by FDA)
- 31 Oct 2018
Tablets · 20 mg
RLD/NDA as listed: Levitra 21400- First PIV submission
- 5 Mar 2009
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 27 Jul 2020
- First applicant approval
- 3 May 2012
- First marketing
- 3 Oct 2018
- Last qualifying patent expiry (as listed by FDA)
- 31 Oct 2018
Tablets · 5 mg and 10 mg
RLD/NDA as listed: Levitra 21400- First PIV submission
- 10 Jul 2009
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 27 Jul 2020
- First applicant approval
- 3 May 2012
- First marketing
- 3 Oct 2018
- Last qualifying patent expiry (as listed by FDA)
- 31 Oct 2018
Vardenafil Hydrochloride
NDA 200179 · 1 row · Listed patents and exclusivities · Open in the app
Orally Disintegrating Tablets · 10 mg
RLD/NDA as listed: Staxyn 200179- First PIV submission
- 22 Dec 2011
- ANDAs
- 1
- 180-day status
- Extinguished Eligible
- Decision posted
- 6/18/2019 6/18/2019
- First applicant approval
- 23 Apr 2015
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 31 Oct 2018
Varenicline Tartrate
NDA 021928 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 0.5 mg and 1 mg
RLD/NDA as listed: Chantix 21928- First PIV submission
- 10 May 2010
- ANDAs
- 5
- 180-day status
- Eligible
- Decision posted
- 7 Sep 2021
- First applicant approval
- 11 Aug 2021
- First marketing
- 21 Sep 2021
- Last qualifying patent expiry (as listed by FDA)
- 3 Aug 2022
Varenicline Tartrate
NDA 213978 · 1 row · Listed patents and exclusivities · Open in the app
Nasal Spray · 0.03 mg/spray
RLD/NDA as listed: Tyrvaya 213978- First PIV submission
- 21 Apr 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)
- 19 Oct 2035
Vasopressin
NDA 204485 · 4 rows · Listed patents and exclusivities · Open in the app
Injection · 20 units/100 mL
RLD/NDA as listed: Vasostrict 204485- First PIV submission
- 20 Dec 2022
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 8 Jan 2024
- First applicant approval
- 6 Dec 2023
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 30 Jan 2035
Injection · 20 units/mL, 1 mL
RLD/NDA as listed: Vasostrict 204485- First PIV submission
- 23 Mar 2018
- ANDAs
- 1
- 180-day status
- Non-Forfeiture Deferred
- Decision posted
- 12/28/2021 12/28/2021
- First applicant approval
- 15 Dec 2021
- First marketing
- 18 Jan 2022
- Last qualifying patent expiry (as listed by FDA)
- 30 Jan 2035
Injection · 200 units/10 mL
RLD/NDA as listed: Vasostrict 204485- First PIV submission
- 29 Jun 2018
- ANDAs
- 1
- 180-day status
- Non-Forfeiture
- Decision posted
- 6 Feb 2023
- First applicant approval
- 6 May 2026
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 30 Jan 2035
Injection · 40 units/100 mL and 60 units/100 mL
RLD/NDA as listed: Vasostrict 204485- First PIV submission
- 28 Feb 2022
- ANDAs
- 1
- 180-day status
- 40 u/100 mL - Extinguished
- Decision posted
- 18 Aug 2025
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 30 Jan 2035
Vecuronium Bromide
NDA 018776 · 1 row · Listed patents and exclusivities · Open in the app
For Injection · 10 mg/vial and 20 mg/vial
RLD/NDA as listed: Norcuron 18776- 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
Venetoclax
NDA 208573 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 10 mg, 50 mg and 100 mg
RLD/NDA as listed: Venclexta 208573- First PIV submission
- 13 Apr 2020
- ANDAs
- 2
- 180-day status
- Deferred
- Decision posted
- 9 Jun 2026
- First applicant approval
- 15 May 2026
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 29 Jan 2032
Venlafaxine Hydrochloride
NDA 020151 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg
RLD/NDA as listed: Effexor 20151- First PIV submission
- 3 Nov 2005
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- 3 Aug 2006
- First marketing
- 15 Jun 2006
- Last qualifying patent expiry (as listed by FDA)
- 13 Jun 2008
Venlafaxine Hydrochloride
NDA 020699 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 37.5 mg, 75 mg and 150 mg
RLD/NDA as listed: Effexor XR 20699- First PIV submission
- 3 May 2007
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 27 Jul 2020
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 20 Mar 2017
Venlafaxine Hydrochloride
NDA 022104 · 2 rows · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 225 mg
RLD/NDA as listed: Venlafaxine Hydrochloride 22104- First PIV submission
- 10 Jan 2011
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 27 Jul 2020
- First applicant approval
- 8 Jan 2019
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 20 Mar 2017
Extended-release Tablets · 37.5 mg, 75 mg and 150 mg
RLD/NDA as listed: Venlafaxine Hydrochloride 22104- First PIV submission
- 12 Feb 2009
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 27 Jul 2020
- First applicant approval
- 18 Aug 2010
- First marketing
- 15 Jun 2006
- Last qualifying patent expiry (as listed by FDA)
- 20 Mar 2017
Verapamil Hydrochloride
NDA 020552 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 240 mg
RLD/NDA as listed: Covera HS 20552- 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
Verapamil Hydrochloride
NDA 020943 · 2 rows · Listed patents and exclusivities · Open in the app
Extended-release Capsules · 100 mg and 200 mg
RLD/NDA as listed: Verelan PM 20943- First PIV submission
- 20 Jul 2006
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 27 Jul 2020
- First applicant approval
- 9 Aug 2007
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 19 Jun 2007
Extended-release Capsules · 300 mg
RLD/NDA as listed: Verelan PM 20943- First PIV submission
- 19 May 2006
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 27 Jul 2020
- First applicant approval
- 9 Aug 2007
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 17 Jun 2007
Vericiguat
NDA 214377 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 2.5 mg
RLD/NDA as listed: Verquvo 214377- First PIV submission
- 21 Jan 2025
- ANDAs
- 5
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 26 Nov 2032
Tablets · 5 mg and 10 mg
RLD/NDA as listed: Verquvo 214377- First PIV submission
- 21 Jan 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)
- 26 Nov 2032
Vibegron
NDA 213006 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 75 mg
RLD/NDA as listed: Gemtesa 213006- First PIV submission
- 23 Dec 2024
- ANDAs
- 4
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 22 Mar 2040
Vilazodone Hydrochloride
NDA 022567 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 10 mg, 20 mg, and 40 mg
RLD/NDA as listed: VIIBRYD 22567- First PIV submission
- 21 Jan 2015
- ANDAs
- 5
- 180-day status
- Eligible
- Decision posted
- 27 Jul 2020
- First applicant approval
- 13 Sep 2019
- First marketing
- 4 Jun 2022
- Last qualifying patent expiry (as listed by FDA)
- 5 Jun 2022
Viloxazine Hydrochloride
NDA 211964 · 3 rows · Listed patents and exclusivities · Open in the app
Extended-release Capsules · 100 mg
RLD/NDA as listed: Qelbree 211964- First PIV submission
- 2 Apr 2025
- ANDAs
- 7
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 2 Apr 2035
Extended-release Capsules · 150 mg
RLD/NDA as listed: Qelbree 211964- First PIV submission
- 2 Apr 2025
- ANDAs
- 7
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 2 Apr 2035
Extended-release Capsules · 200 mg
RLD/NDA as listed: Qelbree 211964- First PIV submission
- 2 Apr 2025
- ANDAs
- 8
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 2 Apr 2035
Vincristine Sulfate
NDA 014103 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 1 mg/mL, 1 mL, 2 mL and 5 mL vials
RLD/NDA as listed: Oncovin 14103- 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
Vismodegib
NDA 203388 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 150 mg
RLD/NDA as listed: Erivedge 203388- First PIV submission
- 27 Mar 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)
- 15 Dec 2028
Voclosporin
NDA 213716 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 7.9 mg
RLD/NDA as listed: Lupkynis 213716- First PIV submission
- 22 Jan 2025
- ANDAs
- 8
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 7 Dec 2037
Voriconazole
NDA 021266 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 50 mg and 200 mg
RLD/NDA as listed: Vfend 21266- First PIV submission
- 14 Apr 2008
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 27 Jul 2020
- First applicant approval
- 22 Apr 2010
- First marketing
- 15 Feb 2011
- Last qualifying patent expiry (as listed by FDA)
- 24 May 2016
Voriconazole
NDA 021267 · 1 row · Listed patents and exclusivities · Open in the app
For Injection · 200 mg/vial
RLD/NDA as listed: Vfend 21267- First PIV submission
- 12 Sep 2008
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 27 Jul 2020
- First applicant approval
- 30 May 2012
- First marketing
- 30 May 2012
- Last qualifying patent expiry (as listed by FDA)
- 2 Jun 2018
Voriconazole
NDA 021630 · 1 row · Listed patents and exclusivities · Open in the app
Oral Suspension · 40 mg/mL
RLD/NDA as listed: Vfend 21630- First PIV submission
- 8 Oct 2010
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 27 Jul 2020
- First applicant approval
- 28 May 2013
- First marketing
- 25 Sep 2013
- Last qualifying patent expiry (as listed by FDA)
- 24 May 2016
Vortioxetine
NDA 204447 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 5 mg, 10 mg, 15 mg and 20 mg
RLD/NDA as listed: Trintellix 204447- First PIV submission
- 2 Oct 2017
- ANDAs
- 15
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 30 Jun 2031
Vosoritide
NDA 214938 · 1 row · Listed patents and exclusivities · Open in the app
Powder for Injection · 0.4 mg/vial 0.56 mg/vial 1.2 mg/vial
RLD/NDA as listed: Voxzogo 214938- First PIV submission
- 19 Nov 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)
- 11 Jul 2042
Voxelotor
NDA 213137 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 300 mg and 500 mg
RLD/NDA as listed: Oxbryta 213137- First PIV submission
- 27 Nov 2023
- ANDAs
- 2
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 12 Oct 2037
Voxelotor
NDA 216157 · 1 row · Listed patents and exclusivities · Open in the app
Tablets for Oral Suspension · 300 mg
RLD/NDA as listed: Oxbryta 216157- First PIV submission
- 27 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)
- 2 Dec 2036
Vutrisiran Sodium
NDA 215515 · 1 row · Listed patents and exclusivities · Open in the app
Subcutaneous Solution · 25 mg/0.5 mL
RLD/NDA as listed: Amvuttra 215515- First PIV submission
- 15 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)
- 28 Jul 2036