COBICISTAT Drug Patent Profile
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When do Cobicistat patents expire, and what generic alternatives are available?
Cobicistat is a drug marketed by Mylan Labs Ltd and is included in one NDA.
The generic ingredient in COBICISTAT is cobicistat. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Cobicistat
A generic version of COBICISTAT was approved as cobicistat by MYLAN LABS LTD on February 7th, 2024.
Summary for COBICISTAT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 60 |
| Clinical Trials: | 128 |
| Patent Applications: | 598 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for COBICISTAT |
| DailyMed Link: | COBICISTAT at DailyMed |
Recent Clinical Trials for COBICISTAT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Maastricht University Medical Center | Phase 4 |
| Food and Drug Administration (FDA) | Phase 1 |
| Spaulding Clinical Research LLC | Phase 1 |
Medical Subject Heading (MeSH) Categories for COBICISTAT
Anatomical Therapeutic Chemical (ATC) Classes for COBICISTAT
Paragraph IV (Patent) Challenges for COBICISTAT
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TYBOST | Tablets | cobicistat | 150 mg | 203094 | 1 | 2016-11-14 |
US Patents and Regulatory Information for COBICISTAT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Labs Ltd | COBICISTAT | cobicistat | TABLET;ORAL | 209986-001 | Feb 7, 2024 | AB | RX | No | No | ⤷ 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 |
EU/EMA Drug Approvals for COBICISTAT
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences Ireland UC | Tybost | cobicistat | EMEA/H/C/002572 Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir. |
Authorised | no | no | no | 2013-09-19 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
