TIOPRONIN - Generic Drug Details
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What are the generic sources for tiopronin and what is the scope of patent protection?
Tiopronin
is the generic ingredient in five branded drugs marketed by Mission Pharmacal, Amneal, Ph Health, Teva Pharms Inc, Torrent, Mission Pharma, Casper Pharma Llc, and Teva Pharms Usa Inc, and is included in nine NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Eight suppliers are listed for this compound.
Summary for TIOPRONIN
| US Patents: | 1 |
| Tradenames: | 5 |
| Applicants: | 8 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Clinical Trials: | 5 |
| Patent Applications: | 4,492 |
| 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 |
|---|---|
| NYU Langone Health | Phase 2 |
| New York University School of Medicine | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Inc | TIOPRONIN | tiopronin | TABLET, DELAYED RELEASE;ORAL | 216456-002 | Jul 22, 2024 | AB | RX | 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 | |||
| Casper Pharma Llc | TIOCYSTIN | tiopronin | TABLET;ORAL | 212927-001 | Jun 2, 2026 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Mission Pharmacal | THIOLA EC | tiopronin | TABLET, DELAYED RELEASE;ORAL | 211843-001 | Jun 28, 2019 | AB | RX | Yes | 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 |
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