LEDIPASVIR; SOFOSBUVIR - Generic Drug Details

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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

Generic Entry Dates for LEDIPASVIR; SOFOSBUVIR^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: PELLETS;ORAL
Generic Entry Dates for LEDIPASVIR; SOFOSBUVIR^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

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

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

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Country	Patent Number	Title	Estimated Expiration
Colombia	6470842	COMPUESTOS ANTIVIRALES	⤷ Sign Up
Japan	2016053096	Ｃ型肝炎ウイルスを処置するための組成物および方法 (COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS)	⤷ Sign Up
New Zealand	623396	Methods for treating hcv	⤷ Sign Up
South Korea	101432860		⤷ Sign Up
Slovenia	2826784		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2013066748		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LEDIPASVIR; SOFOSBUVIR

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2430014	PA2016002	Lithuania	⤷ Sign Up	PRODUCT NAME: LEDIPASVIRAS; REGISTRATION NO/DATE: EU/1/14/958(001-002) 20141118
2203462	1491066-5	Sweden	⤷ Sign Up	PRODUCT NAME: SOFOSBUVIR; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/13/894, 2014-01-17
2430014	2020046	Norway	⤷ Sign Up	PRODUCT NAME: LEDIPASVIR - FORLENGET SPC; REG. NO/DATE: EU/1/14/958 20141203
2203462	92600	Luxembourg	⤷ Sign Up	PRODUCT NAME: SOVALDI (SOFOSBUVIR); AUTHORISATION NUMBER AND DATE: EU/1/13/894(001-002) - SOVALDI - SOFOSBUVIR 20140117
2203462	1490066-6	Sweden	⤷ Sign Up	PRODUCT NAME: SOFOSBUVIR
2203462	14C0082	France	⤷ Sign Up	PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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