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SUNLENCA Drug Patent Profile

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 four patents protecting this drug.

This drug has one hundred and sixty-nine patent family members in forty-five 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:	169
US Patents:	4
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.

Anatomical Therapeutic Chemical (ATC) Classes for SUNLENCA

J05AX	Other antivirals
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for SUNLENCA

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

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
Mexico	2015011478	COMPUESTOS DE AMIDA PARA EL TRATAMIENTO DE VIH. (AMIDE COMPOUNDS FOR THE TREATMENT OF HIV.)
Japan	6893899
Brazil	112018071678	compostos terapêuticos úteis para o tratamento profilático ou terapêutico de uma infecção por vírus hiv
Denmark	2961742

Supplementary Protection Certificates for SUNLENCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3347352	55/2022	Austria		PRODUCT NAME: LENACAPAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, INSBESONDERE LENACAPAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/22/1671 (MITTEILUNG) 20220819
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
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	CA 2022 00052	Denmark		PRODUCT NAME: LENACAPAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NATRIUM-LENACAPAVIR; REG. NO/DATE: EU/1/22/1671 20220819
3347352	C03347352/01	Switzerland		PRODUCT NAME: LENACAPAVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68386 07.07.2023