LEDIPASVIR; SOFOSBUVIR - Generic Drug Details

What are the generic sources for ledipasvir; sofosbuvir and what is the scope of patent protection?

Ledipasvir; sofosbuvir is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ledipasvir; sofosbuvir has five hundred and fifty-five patent family members in forty-eight countries.

Two suppliers are listed for this compound.

Summary for LEDIPASVIR; SOFOSBUVIR

International Patents:	555
US Patents:	17
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Clinical Trials:	98
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEDIPASVIR; SOFOSBUVIR
DailyMed Link:	LEDIPASVIR; SOFOSBUVIR at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LEDIPASVIR; SOFOSBUVIR

Dosage:

PELLETS;ORAL

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.

Recent Clinical Trials for LEDIPASVIR; SOFOSBUVIR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mansoura University	Phase 3
Helwan University	Phase 4
Cairo University	Phase 2/Phase 3

See all LEDIPASVIR; SOFOSBUVIR clinical trials

Pharmacology for LEDIPASVIR; SOFOSBUVIR

Drug Class	Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors RNA Replicase Inhibitors

US Patents and Regulatory Information for LEDIPASVIR; SOFOSBUVIR

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	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-001	Oct 10, 2014		RX	Yes	Yes
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-001	Oct 10, 2014		RX	Yes	Yes					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No			Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-001	Aug 28, 2019		RX	Yes	No					Y

International Patents for LEDIPASVIR; SOFOSBUVIR

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2432792	PROCÉDÉ DE PRODUCTION D'ESTER DE N-[(2'R)-2'-DÉSOXY-2'-FLUORO-2'-MÉTHYL-P-PHÉNYL-5' -URIDYLYL]-L-ALANINE 1-MÉTHYLÉTHYLE (AND PROCESS FOR THE PREPARATION OF N-[(2'R)-2'-DEOXY-2'-FLUORO-2'-METHYL-P-PHENYL-5'-URIDYLYL]-L-ALANINE 1-METHYLETHYL ESTER)
Argentina	080870	PROPANOATO CRISTALINO DE (S)-ISOPROPIL 2-(((S)-(((2R,3R,4R,5R)-5-(2,4-DIOXO-3,4-DIHIDROPIRIMIDIN-1(2H)-IL)-4-FLUORO-3-HIDROXI-4-METILTETRAHIDROFURAN-2-IL)METOXI)(FENOXI)FOSFORIL)AMINO, COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN Y USO DEL MISMO EN EL TRATAMIENTO DE INFECCIONES VIRALES, EN PARTICUL
European Patent Office	2857394	Composés antiviraux (Antiviral compounds)
Mexico	363732	COMPUESTOS ANTIVIRALES. (ANTIVIRAL COMPOUNDS.)
Cyprus	1118048
Japan	2016155875	２種の抗ウイルス化合物のコンビナトリアル製剤 (COMBINATORIAL FORMULATION OF TWO KINDS OF ANTIVIRAL COMPOUNDS)

Supplementary Protection Certificates for LEDIPASVIR; SOFOSBUVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	C 2014 043	Romania		PRODUCT NAME: SOFOSBUVIR; NATIONAL AUTHORISATION NUMBER: EU/1/13/894(001-002); DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/894(001-002); DATE OF FIRST AUTHORISATION IN EEA: 20140116
2430014	CR 2016 00006	Denmark		PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958/001-002 20141118
2430014	132016000015690	Italy		PRODUCT NAME: LEDIPASVIR(HARVONI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/958, 20141118
2430014	16C0005	France		PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958/001-002 20141118
2430014	C20160002 00186	Estonia		PRODUCT NAME: LEDIPASVIIR;REG NO/DATE: EU/1/14/958 18.11.2014
2203462	2014/065	Ireland		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116