Cobicistat; darunavir - Generic Drug Details
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Summary for cobicistat; darunavir
| International Patents: | 350 |
| US Patents: | 8 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 55 |
| DailyMed Link: | cobicistat; darunavir at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for cobicistat; darunavir
Generic Entry Date for cobicistat; darunavir*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for cobicistat; darunavir
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Instituto Mexicano del Seguro Social | PHASE4 |
| Jos Antonio Mata Marn | PHASE4 |
| East Carolina University | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for cobicistat; darunavir
US Patents and Regulatory Information for cobicistat; darunavir
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | RX | Yes | Yes | 8,148,374 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | RX | Yes | Yes | 7,700,645 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Janssen Prods | PREZCOBIX | cobicistat; darunavir ethanolate | TABLET;ORAL | 205395-001 | Jan 29, 2015 | RX | Yes | Yes | 8,148,374 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
