Tiopronin - Generic Drug Details
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What are the generic sources for tiopronin and what is the scope of freedom to operate?
Tiopronin
is the generic ingredient in three branded drugs marketed by Mission Pharmacal, Amneal, Endo Operations, Teva Pharms Inc, Torrent, Mission Pharma, and Teva Pharms Usa Inc, and is included in eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for tiopronin. Six suppliers are listed for this compound.
Summary for tiopronin
| US Patents: | 1 |
| Tradenames: | 3 |
| Applicants: | 7 |
| NDAs: | 8 |
| Drug Master File Entries: | 3 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 5 |
| Patent Applications: | 2,494 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Torrent | TIOPRONIN | tiopronin | TABLET, DELAYED RELEASE;ORAL | 216990-002 | Jan 30, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mission Pharmacal | THIOLA EC | tiopronin | TABLET, DELAYED RELEASE;ORAL | 211843-002 | Jun 28, 2019 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Endo Operations | TIOPRONIN | tiopronin | TABLET;ORAL | 216198-001 | Jun 2, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Pharms Inc | TIOPRONIN | tiopronin | TABLET, DELAYED RELEASE;ORAL | 216456-002 | Jul 22, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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