Ledipasvir; sofosbuvir - Generic Drug Details

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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 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	TABLET;ORAL	205834-001	Oct 10, 2014		RX	Yes	Yes	⤷ 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
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-001	Oct 10, 2014		RX	Yes	Yes	⤷ 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
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes	⤷ 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				⤷ 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
Hong Kong	1213572	'- '- '- '- '-脫氧- '-氟- '-甲基-對-苯基- '- -丙氨酸 -甲基酯和工藝及其生產 (N-[(2R)-2-DEOXY-2-FLUORO-2-METHYL-P-PHENYL-5-URIDYLYL]-L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION N-[(2R)-2--2--2----5-URIDYLYL]-L- 1-)	⤷ Sign Up
China	109970818	核苷氨基磷酸酯前药 (Nucleoside phosphoramidate prodrugs)	⤷ Sign Up
Taiwan	I626047		⤷ Sign Up
Chile	2011000716	Formas cristalinas 1 6 de (s)-isopropil-2-(((s)-(((2r.3r.4r.5r)-5-(2,4-dioxo-3,4-dihidropirimidin-1(2h)-il)-4-fluoro-3-hidroxi-4-metil tetrahidrofuran-2-il)metoxi)(fenoxi)fosforil)amino)propanoato; composicion y combinacion farmaceutica; y su uso para tratar una infeccion por el virus de la hepatitis c.	⤷ Sign Up
Japan	6058528		⤷ Sign Up
Mexico	2009010401	PROFARMACOS DE NUCLEOSIDO FOSFORAMIDATO. (NUCLEOSIDE PHOSPHORAMIDATE PRODRUGS.)	⤷ Sign Up
New Zealand	623602	N-[(2’r)-2’-deoxy-2’-fluoro-2’-methyl-p-phenyl-5’-uridylyl]-l-alanine 1-methylethyl ester and process for its production	⤷ 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	2014/065	Ireland	⤷ Sign Up	PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
2430014	C201630002	Spain	⤷ Sign Up	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	C20160002 00186	Estonia	⤷ Sign Up	PRODUCT NAME: LEDIPASVIIR;REG NO/DATE: EU/1/14/958 18.11.2014
2430014	2016/002	Ireland	⤷ Sign Up	PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141117
2430014	2016004	Norway	⤷ Sign Up	PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958 20141203
2203462	SPC/GB14/078	United Kingdom	⤷ Sign Up	PRODUCT NAME: SOFOSBUVIR; REGISTERED: UK EU/1/13/894/001 20140117; UK EU/1/13/894/002 20140117
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.