THIOLA EC Drug Patent Profile
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When do Thiola Ec patents expire, and what generic alternatives are available?
Thiola Ec is a drug marketed by Mission Pharmacal and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
The generic ingredient in THIOLA EC 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 Ec
A generic version of THIOLA EC was approved as tiopronin by TEVA PHARMS USA INC on April 26th, 2021.
Summary for THIOLA EC
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,141 |
| Drug Prices: | Drug price information for THIOLA EC |
| What excipients (inactive ingredients) are in THIOLA EC? | THIOLA EC excipients list |
| DailyMed Link: | THIOLA EC at DailyMed |
Recent Clinical Trials for THIOLA EC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Florida | Phase 2 |
| E. Sander Connolly | Phase 2 |
| Food and Drug Administration (FDA) | Phase 2 |
Pharmacology for THIOLA EC
| Drug Class | Reducing and Complexing Thiol |
| Mechanism of Action | Cystine Disulfide Reduction |
Anatomical Therapeutic Chemical (ATC) Classes for THIOLA EC
US Patents and Regulatory Information for THIOLA EC
THIOLA EC is protected by one US patents and one FDA Regulatory Exclusivity.
Patents protecting THIOLA EC
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TREATING CYSTINURIA BY ORALLY ADMINISTERING TIOPRONIN WITH FOOD TO PREVENT CYSTINE STONE FORMATION IN ADULTS AND PEDIATRIC PATIENTS WITH SEVERE HOMOZYGOUS CYSTINURIA
FDA Regulatory Exclusivity protecting THIOLA EC
FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
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 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 | |||
| 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 |
