DrugPatentWatch Database Preview
BIKTARVY Drug Profile
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Which patents cover Biktarvy, and what generic alternatives are available?
Biktarvy is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are eleven patents protecting this drug.
This drug has four hundred and eighty-nine 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.
DrugPatentWatch® Generic Entry Outlook for Biktarvy
Biktarvy will be eligible for patent challenges on February 7, 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 November 8, 2036. This may change due to patent challenges or generic licensing.
There have been fourteen 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.
Indicators of Generic Entry
Summary for BIKTARVY
| International Patents: | 489 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 24 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BIKTARVY |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BIKTARVY |
| What excipients (inactive ingredients) are in BIKTARVY? | BIKTARVY excipients list |
| DailyMed Link: | BIKTARVY at DailyMed |
DrugPatentWatch® Estimated 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 |
|---|---|
| Far Eastern Memorial Hospital | N/A |
| Mackay Memorial Hospital | N/A |
| Chi Mei Medical Hospital | N/A |
Pharmacology for BIKTARVY
US Patents and Regulatory Information for BIKTARVY
Expired US Patents for BIKTARVY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | Start Trial | Start Trial |
| Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BIKTARVY
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 030003 | Start Trial |
| Peru | 20170528 | Start Trial |
| Germany | 69130166 | Start Trial |
| Chile | 2017001191 | Start Trial |
| Japan | 5956537 | Start Trial |
| Japan | 2009062383 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BIKTARVY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0513200 | 122004000015 | Germany | Start Trial | PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024 |
| 2822954 | 33/2018 | Austria | Start Trial | PRODUCT NAME: BICTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE BICTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/18/1289 (MITTEILUNG) 20180625 |
| 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 | 122016000024 | Germany | Start Trial | PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119 |
| 1301519 | 2016/014 | Ireland | Start Trial | PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061/001-EU/1/15/1061/002 20151119 |
| 1301519 | CA 2016 00012 | Denmark | Start Trial | PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
