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Last Updated: November 2, 2024

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SUNLENCA Drug Patent Profile


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DrugPatentWatch® Generic Entry Outlook for Sunlenca

Sunlenca will be eligible for patent challenges on December 22, 2026. 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 December 22, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SUNLENCA
International Patents:187
US Patents:5
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 20
Drug Prices: Drug price information for SUNLENCA
What excipients (inactive ingredients) are in SUNLENCA?SUNLENCA excipients list
DailyMed Link:SUNLENCA at DailyMed
Drug patent expirations by year for SUNLENCA
Drug Prices for SUNLENCA

See drug prices for SUNLENCA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SUNLENCA
Generic Entry Dates for SUNLENCA*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS
Generic Entry Dates for SUNLENCA*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
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.

US Patents and Regulatory Information for SUNLENCA

SUNLENCA is protected by five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SUNLENCA is ⤷  Sign Up.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SUNLENCA

Therapeutic compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Therapeutic compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH OTHER ANTIRETROVIRAL(S), FOR THE TREATMENT OF HIV-1 INFECTION IN HEAVILY-TREATMENT EXPERIENCED ADULTS WITH MULTIDRUG RESISTANT HIV-1 INFECTION

Solid forms of an HIV capsid inhibitor
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH OTHER ANTIRETROVIRAL(S), FOR THE TREATMENT OF HIV-1 INFECTION IN HEAVILY-TREATMENT EXPERIENCED ADULTS WITH MULTIDRUG RESISTANT HIV-1 INFECTION

Therapeutic compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH OTHER ANTIRETROVIRAL(S), FOR THE TREATMENT OF HIV-1 INFECTION IN HEAVILY-TREATMENT EXPERIENCED ADULTS WITH MULTIDRUG RESISTANT HIV-1 INFECTION

FDA Regulatory Exclusivity protecting SUNLENCA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

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 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
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 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 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 SUNLENCA

See the table below for patents covering SUNLENCA around the world.

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 SUNLENCA

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

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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.