THIOLA Drug Patent Profile
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Which patents cover Thiola, and when can generic versions of Thiola launch?
Thiola is a drug marketed by Mission Pharma and Mission Pharmacal and is included in two NDAs. There is one patent protecting this drug.
The generic ingredient in THIOLA is tiopronin. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tiopronin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Thiola
A generic version of THIOLA was approved as tiopronin by TEVA PHARMS USA INC on April 26th, 2021.
Summary for THIOLA
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,312 |
| Drug Prices: | Drug price information for THIOLA |
| What excipients (inactive ingredients) are in THIOLA? | THIOLA excipients list |
| DailyMed Link: | THIOLA at DailyMed |
Recent Clinical Trials for THIOLA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| E. Sander Connolly | Phase 2 |
| Food and Drug Administration (FDA) | Phase 2 |
| University of Washington | Phase 2 |
Pharmacology for THIOLA
| Drug Class | Reducing and Complexing Thiol |
| Mechanism of Action | Cystine Disulfide Reduction |
Anatomical Therapeutic Chemical (ATC) Classes for THIOLA
US Patents and Regulatory Information for THIOLA
THIOLA is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting THIOLA
INDICATED IN COMBINATION WITH HIGH FLUID INTAKE, ALKALI, AND DIET MODIFICATION, FOR THE PREVENTION OF CYSTINE STONE FORMATION IN PEDIATRIC PATIENTS 20KG TO 9 YEARS OF AGE W/SEVERE HOMOZYGOUS CYSTINURIA, WHO ARE NOT RESPONSIVE TO THESE MEASURES ALONE
Exclusivity Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mission Pharma | THIOLA | tiopronin | TABLET;ORAL | 019569-001 | Aug 11, 1988 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mission Pharmacal | THIOLA EC | tiopronin | TABLET, DELAYED RELEASE;ORAL | 211843-002 | Jun 28, 2019 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mission Pharmacal | THIOLA EC | tiopronin | TABLET, DELAYED RELEASE;ORAL | 211843-001 | Jun 28, 2019 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mission Pharmacal | THIOLA EC | tiopronin | TABLET, DELAYED RELEASE;ORAL | 211843-001 | Jun 28, 2019 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mission Pharmacal | THIOLA EC | tiopronin | TABLET, DELAYED RELEASE;ORAL | 211843-002 | Jun 28, 2019 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
