Details for Patent: 11,458,104
Which drugs does patent 11,458,104 protect, and when does it expire?
Patent 11,458,104 protects THIOLA EC and is included in one NDA.
Summary for Patent: 11,458,104
| Title: | Enteric coated tiopronin tablet |
| Abstract: | A solid pharmaceutical composition is provided that includes a core, an inner coating, and an outer coating. The core includes tiopronin as an active agent. Further, the inner coating, which includes a cellulose-based polymer, surrounds the core, and the outer coating, which includes an enteric polymer, surrounds the inner coating. As a result of the specific components of the solid pharmaceutical composition, the solid pharmaceutical composition exhibits a fed state Cmax of tiopronin that is at least 70% of a 12-hour fasted state Cmax of tiopronin after oral administration of the solid pharmaceutical composition when administered as a 300 milligram dose. As such, it is possible for the solid pharmaceutical composition to be administered orally with or without food (e.g., in a fed or fasted state) while still achieving a desired maximum plasma concentration of the tiopronin in a delayed release formulation. |
| Inventor(s): | Jon Taylor, Stuart Smoot, Stuart Schoenherr, Paul Werchan |
| Assignee: | Mission Pharmacal Co |
| Application Number: | US16/562,224 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 11,458,104 |
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Patent Claim Types: see list of patent claims | Use; Composition; Formulation; Dosage form; |
Drugs Protected by US Patent 11,458,104
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mission Pharmacal | THIOLA EC | tiopronin | TABLET, DELAYED RELEASE;ORAL | 211843-001 | Jun 28, 2019 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | 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 | ⤷ Start Trial | |||
| Mission Pharmacal | THIOLA EC | tiopronin | TABLET, DELAYED RELEASE;ORAL | 211843-002 | Jun 28, 2019 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | 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 | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
