DrugPatentWatch Database Preview
BIKTARVY Drug Profile
» See Plans and Pricing
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 seventy-three 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 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 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.
Indicators of Generic Entry
Summary for BIKTARVY
| International Patents: | 473 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 16 |
| 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 |
|---|---|
| Peking Union Medical College Hospital | Phase 4 |
| Judit Pich Martínez | Phase 3 |
| Gilead Sciences | N/A |
Pharmacology for BIKTARVY
US Patents and Regulatory Information for BIKTARVY
International Patents for BIKTARVY
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20200067930 | Start Trial |
| Romania | 122814 | Start Trial |
| Japan | 2011140506 | Start Trial |
| African Regional IP Organization (ARIPO) | 3639 | Start Trial |
| Argentina | 106645 | Start Trial |
| Monaco | 2233 | 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 | PA2018511,C2822954 | Lithuania | Start Trial | PRODUCT NAME: BIKTEGRAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC NATRIO BIKTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/18/1289 20180621 |
| 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 |
| 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 | 18C1035 | France | Start Trial | PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625 |
| 0513200 | SZ 7/2004 | Austria | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
