Details for Patent: 8,754,065
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Which drugs does patent 8,754,065 protect, and when does it expire?
Patent 8,754,065 protects SYMTUZA, BIKTARVY, DESCOVY, GENVOYA, ODEFSEY, and VEMLIDY, and is included in six NDAs.
Protection for BIKTARVY has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.
This patent has fifty-seven patent family members in forty-one countries.
Summary for Patent: 8,754,065
| Title: | Tenofovir alafenamide hemifumarate |
| Abstract: | A hemifumarate form of 9-[(R)-2-[[(S)-[[(S)-1-(isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]- methoxy]propyl]adenine (tenofovir alafenamide), and antiviral therapy using tenofovir alafenamide hemifumarate (e.g., anti-HIV and anti-HBV therapies). |
| Inventor(s): | Liu; Dazhan (Alberta, CA), Shi; Bing (Foster City, CA), Wang; Fang (Foster City, CA), Yu; Richard Hung Chiu (San Francisco, CA) |
| Assignee: | Gilead Sciences, Inc. (CA) |
| Application Number: | 13/586,358 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 8,754,065 |
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Patent Claim Types: see list of patent claims | Compound; Composition; Use; Process; Formulation; |
Drugs Protected by US Patent 8,754,065
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS | ⤷ Sign Up | ||
| Janssen Prods | SYMTUZA | cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210455-001 | Jul 17, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS | ⤷ Sign Up | ||
| Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-002 | Oct 7, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||||
| Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||||
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-002 | Jan 7, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||||
| Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-001 | Apr 4, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
International Family Members for US Patent 8,754,065
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| African Regional IP Organization (ARIPO) | 3639 | ⤷ Sign Up | |||
| Argentina | 087546 | ⤷ Sign Up | |||
| Australia | 2012296622 | ⤷ Sign Up | |||
| Australia | 2014271320 | ⤷ Sign Up | |||
| Brazil | 112014003420 | ⤷ Sign Up | |||
| Canada | 2845553 | ⤷ Sign Up | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
