Drybench Patent.
TIOPRONIN, NDA 211843
The patents and exclusivities FDA's Orange Book lists for NDA 211843 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 28 Jun 2026 to 14 Nov 2038, each by its own rule; no one date stands for this product.
- Earliest listed date
- 28 Jun 2026ODE* exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 1,003–1,004
- Latest listed date
- 14 Nov 2038US 11,458,104, use patentRule R1 · Products 001, 002 · patent.txt lines 13,213–13,214
- Latest substance patent
- None listed
- Latest listed patent
- 14 Nov 2038US 11,458,104, use patentRule R1 · Products 001, 002 · patent.txt lines 13,213–13,214
- Latest exclusivity
- 28 Jun 2026ODE* exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 1,003–1,004
2 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 211843, as listed. The sections below name products by these numbers.
Product 001 · THIOLA EC
- Dosage form; route
- TABLET, DELAYED RELEASE;ORAL
- Strength
- 100MG
- Approval date as listed
- 28 Jun 2019
- Type as listed
- RX
- Applicant as listed
- MISSION PHARMACAL CO
Product 002 · THIOLA EC
- Dosage form; route
- TABLET, DELAYED RELEASE;ORAL
- Strength
- 300MG
- Approval date as listed
- 28 Jun 2019
- Type as listed
- RX
- Applicant as listed
- MISSION PHARMACAL CO
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 2 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 11,458,104, use patent
patent.txt lines 13,213–13,214- Expiry as listed
- 14 Nov 2038
- Rule
- R1
- Flags
- use code U-3441
- Product numbers
- 001, 002
Listed exclusivities
Each exclusivity FDA lists for NDA 211843, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
ODE* exclusivity
exclusivity.txt lines 1,003–1,004- Date
- 28 Jun 2026
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
Paragraph IV list rows giving NDA 211843
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 211843, 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 211843
Tiopronin · Delayed-release Tablets · 100 mg
RLD/NDA as listed: Thiola EC 211843- First PIV submission
- 11 Oct 2022
- ANDAs
- 2
- 180-day status
- Eligible
- Decision posted
- 6 Mar 2023
- First applicant approval
- 24 Feb 2023
- First marketing
- 24 Feb 2023
- Last qualifying patent expiry (as listed by FDA)
- 14 Nov 2038
Tiopronin · Delayed-release Tablets · 300 mg
RLD/NDA as listed: Thiola EC 211843- First PIV submission
- 11 Oct 2022
- ANDAs
- 2
- 180-day status
- Eligible
- Decision posted
- 6 Mar 2023
- First applicant approval
- 24 Feb 2023
- First marketing
- 24 Feb 2023
- Last qualifying patent expiry (as listed by FDA)
- 14 Nov 2038
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