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BIKTARVY Drug Profile
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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 twenty-six 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.
US ANDA Litigation and Generic Entry Outlook for Biktarvy
Biktarvy will be eligible for patent challenges on February 7th, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 19th, 2035. This may change due to patent challenges or generic licensing.
There have been thirteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Summary for BIKTARVY
| International Patents: | 426 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 11 |
| 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 |
|---|---|
| Azienda Ospedaliera San Paolo | Phase 3 |
| Ospedale Policlinico San Martino | Phase 3 |
| Catholic University of the Sacred Heart | Phase 3 |
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 |
Pharmacology for BIKTARVY
US Patents and Regulatory Information for BIKTARVY
International Patents for BIKTARVY
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 698859 | Start Trial |
| China | 1920050 | Start Trial |
| Norway | 970385 | Start Trial |
| Romania | 122814 | Start Trial |
| Ukraine | 115311 | Start Trial |
| Hungary | 9202496 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BIKTARVY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1301519 | SPC/GB16/015 | United Kingdom | Start Trial | PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTERED: UK EU/1/15/1061/001 20151123; UK EU/1/15/1061/002 20151123 |
| 1301519 | C 2016 011 | Romania | Start Trial | PRODUCT NAME: TENOFOVIR ALAFENAMIDA SAU O SARE SAU SOLVAT AL ACESTUIA, IN SPECIAL FUMARAT DE TENOFOVIR ALAFENAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1061/001-002; DATE OF NATIONAL AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1061/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20151119 |
| 2822954 | 2018C/031 | Belgium | Start Trial | PRODUCT NAME: BICTEGRAVIR OF EEN FARMACEUTISCH ANVAARDBAAR ZOUT HIERVAN, IN HET BIJZONDER NATRIUMBICTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625 |
| 2822954 | 2018026 | Norway | Start Trial | PRODUCT NAME: BICTEGRAVIR ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV, SPESIELT NATRIUMBICTEGRAVIR; AUTHORISATION NUMBER/DATE: NO, EU/1/18/1289, BIKTARVY, 20180625 |
| 1301519 | PA2016009,C1301519 | Lithuania | Start Trial | PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS ARBA JO DRUSKA ARBA SOLVATAS, YPATINGAI TENOFOVIRO ALAFENAMIDO FUMARATAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119 |
| 2822954 | 122018000094 | Germany | Start Trial | PRODUCT NAME: BICTEGRAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BICTEGRAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180621 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
