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SUNLENCA Drug Patent Profile

When do Sunlenca patents expire, and what generic alternatives are available?

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

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

See drug prices for SUNLENCA

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

215973

Dosage:

SOLUTION;SUBCUTANEOUS

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.

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

FDA Regulatory Exclusivity protecting SUNLENCA

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
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	TABLET;ORAL	215974-001	Dec 22, 2022		RX	Yes	Yes			Y	Y
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	SOLUTION;SUBCUTANEOUS	215973-001	Dec 22, 2022		RX	Yes	Yes			Y	Y
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	TABLET;ORAL	215974-001	Dec 22, 2022		RX	Yes	Yes
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	TABLET;ORAL	215974-001	Dec 22, 2022		RX	Yes	Yes			Y	Y
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	SOLUTION;SUBCUTANEOUS	215973-001	Dec 22, 2022		RX	Yes	Yes

International Patents for SUNLENCA

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

Country	Patent Number	Title	Estimated Expiration
Argentina	118856	COMPUESTOS TERAPÉUTICOS
China	117285514	HIV衣壳抑制剂的固体形式 (Solid forms of HIV capsid inhibitors)
Japan	2019528280	ＨＩＶウイルス感染症の予防的または治療的処置に有用な治療用化合物
Australia	2017312102
Taiwan	I715944
Cuba	20150096	COMPUESTOS DE AMIDA Y COMPOSICIÓN FARMACÉUTICA PARA EL TRATAMIENTO DE VIH

Supplementary Protection Certificates for SUNLENCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3347352	PA2023501,C3347352	Lithuania		PRODUCT NAME: LENAKAPAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC LENAKAPAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/22/1671/001-002 20220817
3347352	122022000082	Germany		PRODUCT NAME: LENACAPAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE LENACAPAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/22/1671 20220817
3347352	301212	Netherlands		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		PRODUCT NAME: LENACAPAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NATRIUM-LENACAPAVIR; REG. NO/DATE: EU/1/22/1671 20220819
3347352	C202330002	Spain		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		PRODUCT NAME: LENACAPAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LENACAPAVIR SODIQUE; REGISTRATION NO/DATE: EU/1/22/1671 20220819