Drybench Patent.
LEVOTHYROXINE SODIUM, NDA 021924
The patents and exclusivities FDA's Orange Book lists for NDA 021924 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.
FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.
- Orange Book captured
- 14 October 2026
- Paragraph IV list captured
- 17 October 2026
- Last checked
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.
Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.
Listed protection
Listed dates run from 26 Sep 2044 to 26 Sep 2044, each by its own rule; no one date stands for this product.
- Earliest listed date
- 26 Sep 2044US 12,564,565, product patentRule R1 · Products 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016 · patent.txt lines 785–799
- Latest listed date
- 26 Sep 2044US 12,564,565, product patentRule R1 · Products 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016 · patent.txt lines 785–799
- Latest substance patent
- None listed
- Latest listed patent
- 26 Sep 2044US 12,564,565, product patentRule R1 · Products 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016 · patent.txt lines 785–799
- Latest exclusivity
- None listed
Products
Each product number FDA lists under NDA 021924, as listed. The sections below name products by these numbers.
Product 002 · TIROSINT
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 0.025MG
- Approval date as listed
- 13 Oct 2006
- Type as listed
- RX
- Applicant as listed
- IBSA INSTITUT BIOCHIMIQUE SA
Product 003 · TIROSINT
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 0.05MG
- Approval date as listed
- 13 Oct 2006
- Type as listed
- RX
- Applicant as listed
- IBSA INSTITUT BIOCHIMIQUE SA
Product 004 · TIROSINT
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 0.075MG
- Approval date as listed
- 13 Oct 2006
- Type as listed
- RX
- Applicant as listed
- IBSA INSTITUT BIOCHIMIQUE SA
Product 005 · TIROSINT
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 0.1MG
- Approval date as listed
- 13 Oct 2006
- Type as listed
- RX
- Applicant as listed
- IBSA INSTITUT BIOCHIMIQUE SA
Product 006 · TIROSINT
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 0.125MG
- Approval date as listed
- 13 Oct 2006
- Type as listed
- RX
- Applicant as listed
- IBSA INSTITUT BIOCHIMIQUE SA
Product 007 · TIROSINT
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 0.15MG
- Approval date as listed
- 13 Oct 2006
- Type as listed
- RX
- Applicant as listed
- IBSA INSTITUT BIOCHIMIQUE SA
Product 008 · TIROSINT
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 0.112MG
- Approval date as listed
- 2 Oct 2009
- Type as listed
- RX
- Applicant as listed
- IBSA INSTITUT BIOCHIMIQUE SA
Product 009 · TIROSINT
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 0.137MG
- Approval date as listed
- 2 Oct 2009
- Type as listed
- RX
- Applicant as listed
- IBSA INSTITUT BIOCHIMIQUE SA
Product 010 · TIROSINT
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 0.088MG
- Approval date as listed
- 2 Oct 2009
- Type as listed
- RX
- Applicant as listed
- IBSA INSTITUT BIOCHIMIQUE SA
Product 011 · TIROSINT
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 0.175MG
- Approval date as listed
- 25 Apr 2017
- Type as listed
- RX
- Applicant as listed
- IBSA INSTITUT BIOCHIMIQUE SA
Product 012 · TIROSINT
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 0.2MG
- Approval date as listed
- 25 Apr 2017
- Type as listed
- RX
- Applicant as listed
- IBSA INSTITUT BIOCHIMIQUE SA
Product 013 · TIROSINT
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 0.013MG
- Approval date as listed
- 1 Aug 2007
- Type as listed
- RX
- Applicant as listed
- IBSA INSTITUT BIOCHIMIQUE SA
Product 014 · TIROSINT
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 0.0375MG
- Approval date as listed
- 22 Jun 2022
- Type as listed
- RX
- Applicant as listed
- IBSA INSTITUT BIOCHIMIQUE SA
Product 015 · TIROSINT
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 0.044MG
- Approval date as listed
- 22 Jun 2022
- Type as listed
- RX
- Applicant as listed
- IBSA INSTITUT BIOCHIMIQUE SA
Product 016 · TIROSINT
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 0.0625MG
- Approval date as listed
- 22 Jun 2022
- Type as listed
- RX
- Applicant as listed
- IBSA INSTITUT BIOCHIMIQUE SA
Listed patents
Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.
1 entry from 15 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 12,564,565, product patent
patent.txt lines 785–799- Expiry as listed
- 26 Sep 2044
- Rule
- R1
- Flags
- product
- Product numbers
- 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016
Listed exclusivities
Each exclusivity FDA lists for NDA 021924, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
The Orange Book capture of 14 October 2026 lists no exclusivity for NDA 021924.
Paragraph IV list rows giving NDA 021924
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 021924, each cell as listed.
FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.
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.
Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.
Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 021924
Levothyroxine Sodium · 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
Levothyroxine Sodium · 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
Levothyroxine Sodium · 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
Levothyroxine Sodium · 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
Levothyroxine Sodium · 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
Notes from the trace
- R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.
Patents vs FDA exclusivityHow to read the Orange Book data filesParagraph IV certificationWhat changed, by week