TIOPRONIN Drug Patent Profile
Which patents cover Tiopronin, and what generic alternatives are available?
Tiopronin is a drug marketed by Amneal, Ph Health, Teva Pharms Inc, and Teva Pharms Usa Inc. and is included in five NDAs.
The generic ingredient in TIOPRONIN is tiopronin. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the tiopronin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tiopronin
A generic version of TIOPRONIN was approved as tiopronin by TEVA PHARMS USA INC on April 26th, 2021.
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Summary for TIOPRONIN
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Clinical Trials: | 5 |
| Patent Applications: | 2,875 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TIOPRONIN |
| What excipients (inactive ingredients) are in TIOPRONIN? | TIOPRONIN excipients list |
| DailyMed Link: | TIOPRONIN at DailyMed |
Recent Clinical Trials for TIOPRONIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| New York University School of Medicine | Phase 2 |
| NYU Langone Health | Phase 2 |
| Revive Therapeutics, Ltd. | Phase 2 |
Pharmacology for TIOPRONIN
| Drug Class | Reducing and Complexing Thiol |
| Mechanism of Action | Cystine Disulfide Reduction |
Anatomical Therapeutic Chemical (ATC) Classes for TIOPRONIN
US Patents and Regulatory Information for TIOPRONIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | TIOPRONIN | tiopronin | TABLET, DELAYED RELEASE;ORAL | 216278-002 | Aug 29, 2025 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Ph Health | TIOPRONIN | tiopronin | TABLET;ORAL | 216198-001 | Jun 2, 2022 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Ph Health | TIOPRONIN | tiopronin | TABLET, DELAYED RELEASE;ORAL | 217219-002 | Feb 24, 2023 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
