FDA Orange Book · active-ingredient family
Cobicistat
Cobicistat: 1 brand, 1 generic; first approved Sep 24, 2014; generic available.
Generic available1 exclusivity periodHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
1
Listed patents
4
Next patent expiry
Sep 03, 2029
in 3 yr 1 mo
Brand (NDA) products
Originator applications
- TYBOSTRLDGILEAD SCIENCES INCNDA 20309420252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — 90MG TABLET ORAL Discontinued —
Generic (ANDA) products (1)
Abbreviated applications
- COBICISTATMYLAN LABS LTDANDA 2099862024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- ODE-260Orphan-drug exclusivity (7 years)
2 d ago
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8148374 | in 3 yr 1 mo | SubstanceProductU-1279 | |
| 8148374*PED | in 3 yr 7 mo | ||
| 10039718 | in 6 yr 3 mo | Product | |
| 10039718*PED | in 6 yr 9 mo |
Approval history
FDA approval span
First approval
12 yr 1 mo ago
Most recent approval
1 yr 2 mo ago
Approvals span 2014–2025 across 2 FDA applications.
Brand (NDA) 150%
Generic (ANDA) 150%
Cobicistat: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
