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SUNLENCA Drug Patent Profile

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When do Sunlenca patents expire, and when can generic versions of Sunlenca launch?

Sunlenca is a drug marketed by Gilead Sciences Inc and is included in two NDAs. There are five patents protecting this drug.

This drug has one hundred and eighty-eight patent family members in forty-six countries.

The generic ingredient in SUNLENCA is lenacapavir sodium. One supplier is listed for this compound. Additional details are available on the lenacapavir sodium profile page.

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:	188
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SUNLENCA

Generic Entry Dates for SUNLENCA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 215973 Dosage: SOLUTION;SUBCUTANEOUS
Generic Entry Dates for SUNLENCA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 215974 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 SUNLENCA

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

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

FDA Regulatory Exclusivity protecting SUNLENCA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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
>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.

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Country	Patent Number	Title	Estimated Expiration
Taiwan	I694071		⤷ Sign Up
South Korea	20230011471		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2020018459		⤷ Sign Up
Hong Kong	1222169	用於治療人體免疫缺損病毒的化合物 (AMIDE COMPOUNDS FOR THE TREATMENT OF HIV (HIV))	⤷ Sign Up
China	112423750	用于治疗HIV的衣壳抑制剂 (CAPSID INHIBITORS FOR THE TREATMENT OF HIV)	⤷ Sign Up
Argentina	094990	DERIVADOS DE AMIDA Y SU USO PARA EL TRATAMIENTO DE INFECCIÓN POR VIH	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SUNLENCA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3347352	C202330002	Spain	⤷ Sign Up	PRODUCT NAME: LENACAPAVIR O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR LENACAPAVIR SODICO; NATIONAL AUTHORISATION NUMBER: EU/1/22/1671; DATE OF AUTHORISATION: 20220817; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1671; DATE OF FIRST AUTHORISATION IN EEA: 20220817
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	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	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	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