Ledipasvir; sofosbuvir - Generic Drug Details

What are the generic sources for ledipasvir; sofosbuvir and what is the scope of freedom to operate?

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 forty-three patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for ledipasvir; sofosbuvir

International Patents:	543
US Patents:	17
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	98
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ledipasvir; sofosbuvir
DailyMed Link:	ledipasvir; sofosbuvir at DailyMed

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

Anatomical Therapeutic Chemical (ATC) Classes for ledipasvir; sofosbuvir

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

International Patents for ledipasvir; sofosbuvir

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2552933	HYDRATE DE L'ISOPROPYL ESTER DE L'ACIDE (S)-2-{(S)-[(1R,4R,5R)-5-(2-AMINO-6-METHOXY- PURIN-9-YL)-4-(R)-FLUORO-3-HYDROXY-4-METHYL-TETRAHYDRO-FURAN-2-YLMETHOXY]- PHENOXY-PHOSPHORYLAMINO}-PROPIONIQUE DANS L'UTILISATION POUR LE TRAITEMENT DU VHC ((S)-2-{(S)-[(1R,4R,5R)-5-(2-AMINO-6-METHOXY- PURIN-9-YL)-4-(R)-FLUORO-3-HYDROXY-4-METHYL-TETRAHYDRO-FURAN-2-YLMETHOXY]- PHENOXY-PHOSPHORYLAMINO}-PROPIONIC ACID ISOPROPYL ESTER HYDRATE FOR USE IN TREATING HCV)
Brazil	112012024923	"fosforamidatos de nucleosídeo, composição, comprimido, e seus usos"
Israel	216254	תרכובות , הרכבים פרמצבטיים ושימושים שלהם (Compounds, pharmaceutical compositions comprising the same and uses thereof)
Taiwan	201136593	Nucleoside phosphoramidates
Brazil	112014012739	composições e métodos para o tratamento do vírus da hepatite c

Supplementary Protection Certificates for ledipasvir; sofosbuvir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2430014	122016000009	Germany		PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141117
2430014	C201630002	Spain		PRODUCT NAME: LEDIPASVIR; NATIONAL AUTHORISATION NUMBER: EU/1/14/958; DATE OF AUTHORISATION: 20141117; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/958; DATE OF FIRST AUTHORISATION IN EEA: 20141117
2430014	4/2016	Austria		PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 (MITTEILUNG) 20141118
2203462	122014000108	Germany		PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2430014	C20160002	Estonia		PRODUCT NAME: LEDIPASVIIR; NATIONAL AUTHORISATION NUMBER: EMA/498767/2019; DATE OF AUTHORISATION: 20200430