DrugPatentWatch Database Preview
BIKTARVY Drug Profile
When do Biktarvy patents expire, and when can generic versions of Biktarvy launch?
Biktarvy is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are ten patents protecting this drug.
This drug has four hundred and nineteen patent family members in sixty-four countries.
The generic ingredient in BIKTARVY is bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate. One supplier is listed for this compound. Additional details are available on the bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate profile page.
Summary for BIKTARVY
| International Patents: | 419 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 10 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BIKTARVY |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BIKTARVY |
| DailyMed Link: | BIKTARVY at DailyMed |
Generic Entry Opportunity Date for BIKTARVY
Generic Entry Date for BIKTARVY*:
Constraining patent/regulatory exclusivity:
NDA:
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 BIKTARVY
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Nebraska | Phase 4 |
| Professor Saye Khoo MD, FRCP | Phase 4 |
| Emory University | Phase 4 |
Recent Litigation for BIKTARVY
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| GILEAD SCIENCES, INC. v. ZYDUS PHARMACEUTICALS (USA) INC. | 2019-01-15 |
| GILEAD SCIENCES, INC. v. STRIDES PHARMA, INC. | 2018-06-27 |
| Gilead Sciences, Inc. v. Aurobindo Pharma Ltd. | 2018-05-18 |
US Patents and Regulatory Information for BIKTARVY
International Patents for BIKTARVY
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 100749160 | Start Trial |
| New Zealand | 620421 | Start Trial |
| Hungary | 9302493 | Start Trial |
| Iceland | 6689 | Start Trial |
| Taiwan | 201321396 | Start Trial |
| Finland | 923446 | Start Trial |
| China | 107674086 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BIKTARVY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2822954 | LUC00083 | Luxembourg | Start Trial | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625 |
| 2822954 | C20180024 00269 | Estonia | Start Trial | PRODUCT NAME: BIKTEGRAVIIR;REG NO/DATE: EU/1/18/1289 25.06.2018 |
| 2822954 | 300947 | Netherlands | Start Trial | PRODUCT NAME: BICTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BICTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625 |
| 2822954 | C201830044 | Spain | Start Trial | PRODUCT NAME: BICTEGRAVIR O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR BICTEGRAVIR SODIO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1289; DATE OF AUTHORISATION: 20180621; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1289; DATE OF FIRST AUTHORISATION IN EEA: 20180621 |
| 0513200 | 300148 | Netherlands | Start Trial | 300148, 20110131, EXPIRES: 20160130 |
| 1301519 | 300803 | Netherlands | Start Trial | PRODUCT NAME: TENOFOVIRALAFENAMIDE OF EEN ZOUT OF SOLVAAT DAARVAN, MET NAME TENOFOVIRALAFENAMIDEFUMARAAT; NATIONAL REGISTRATION NO/DATE: EU/1/15/1061/002 20151123; FIRST REGISTRATION: EU EU/1/15/1061/001 20151123 |
| 2822954 | 1890030-8 | Sweden | Start Trial | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
