LENACAPAVIR SODIUM - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for lenacapavir sodium and what is the scope of freedom to operate?
Lenacapavir sodium
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Lenacapavir sodium has one hundred and eighty-seven patent family members in forty-six countries.
One supplier is listed for this compound.
Summary for LENACAPAVIR SODIUM
| International Patents: | 187 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| What excipients (inactive ingredients) are in LENACAPAVIR SODIUM? | LENACAPAVIR SODIUM excipients list |
| DailyMed Link: | LENACAPAVIR SODIUM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LENACAPAVIR SODIUM
Generic Entry Dates for LENACAPAVIR SODIUM*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
SOLUTION;SUBCUTANEOUS |
Generic Entry Dates for LENACAPAVIR SODIUM*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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.
Pharmacology for LENACAPAVIR SODIUM
| Drug Class | Human Immunodeficiency Virus 1 Capsid Inhibitor |
| Mechanism of Action | Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A Inhibitors HIV Capsid Inhibitors P-Glycoprotein Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for LENACAPAVIR SODIUM
US Patents and Regulatory Information for LENACAPAVIR SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | TABLET;ORAL | 215974-001 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | TABLET;ORAL | 215974-001 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | TABLET;ORAL | 215974-001 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | SOLUTION;SUBCUTANEOUS | 215973-001 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | SOLUTION;SUBCUTANEOUS | 215973-001 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | TABLET;ORAL | 215974-001 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Gilead Sciences Inc | SUNLENCA | lenacapavir sodium | SOLUTION;SUBCUTANEOUS | 215973-001 | Dec 22, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for LENACAPAVIR SODIUM
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2018317833 | Solid forms of an HIV capsid inhibitor | ⤷ Sign Up |
| China | 111051296 | HIV衣壳抑制剂的固体形式 (SOLID FORMS OF AN HIV CAPSID INHIBITOR) | ⤷ Sign Up |
| Poland | 3668859 | ⤷ Sign Up | |
| Croatia | P20181679 | ⤷ Sign Up | |
| Portugal | 3409667 | ⤷ Sign Up | |
| Costa Rica | 20190504 | COMPUESTO DE AMIDA (Divisional 2015-0454) | ⤷ Sign Up |
| Poland | 3597646 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LENACAPAVIR SODIUM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3347352 | 22C1063 | France | ⤷ Sign Up | PRODUCT NAME: LENACAPAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LENACAPAVIR SODIQUE; REGISTRATION NO/DATE: EU/1/22/1671 20220819 |
| 3347352 | 2290051-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REG. NO/DATE: EU/1/22/1671 20220819 |
| 3347352 | C03347352/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: LENACAPAVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68386 07.07.2023 |
| 3347352 | 301212 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LENACAPAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER LENACAPAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/22/1671 20220819 |
| 3347352 | CR 2022 00052 | Denmark | ⤷ Sign Up | PRODUCT NAME: LENACAPAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NATRIUM-LENACAPAVIR; REG. NO/DATE: EU/1/22/1671 20220819 |
| 3347352 | 55/2022 | Austria | ⤷ Sign Up | PRODUCT NAME: LENACAPAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, INSBESONDERE LENACAPAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/22/1671 (MITTEILUNG) 20220819 |
| 3347352 | PA2023501 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LENAKAPAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC LENAKAPAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/22/1671/001-002 20220817 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
