Sofosbuvir - Generic Drug Details

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

Sofosbuvir is the generic ingredient in four branded drugs marketed by Gilead Sciences Inc and Teva Pharms Usa Inc, and is included in six NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir has three hundred and sixty-two patent family members in forty-eight countries.

There are nine drug master file entries for sofosbuvir. One supplier is listed for this compound.

Summary for sofosbuvir

International Patents:	362
US Patents:	22
Tradenames:	4
Applicants:	2
NDAs:	6
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	323
Patent Applications:	1,592
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sofosbuvir
What excipients (inactive ingredients) are in sofosbuvir?	sofosbuvir excipients list
DailyMed Link:	sofosbuvir at DailyMed

Recent Clinical Trials for sofosbuvir

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

Sponsor	Phase
Burnet Institute	Early Phase 1
UNITAID	Early Phase 1
Médecins du Monde	Early Phase 1

See all sofosbuvir clinical trials

Pharmacology for sofosbuvir

Drug Class	Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	RNA Replicase Inhibitors

Medical Subject Heading (MeSH) Categories for sofosbuvir

Antiviral Agents

Anatomical Therapeutic Chemical (ATC) Classes for sofosbuvir

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

Paragraph IV (Patent) Challenges for SOFOSBUVIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SOVALDI	Tablets	sofosbuvir	400 mg	204671	2	2017-12-06

US Patents and Regulatory Information for 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	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-001	Jun 10, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-002	Aug 28, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Gilead Sciences Inc	SOVALDI	sofosbuvir	PELLETS;ORAL	212480-002	Aug 28, 2019		RX	Yes	Yes	⤷ 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

EU/EMA Drug Approvals for sofosbuvir

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Sovaldi	sofosbuvir	EMEA/H/C/002798 Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.	Authorised	no	no	no	2014-01-16
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for sofosbuvir

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Country	Patent Number	Title	Estimated Expiration
Japan	5318085		⤷ Sign Up
Argentina	088580	METODOS Y COMPOSICIONES PARA TRATAR EL VIRUS DE LA HEPATITIS C	⤷ Sign Up
Israel	239115	N-[(2'-r)-2'-דאוקסי-2'-פלואורו-2'-מתיל-p-פניל-5'-אורידיליל]-l-אלאנינ-1-מתילאתילאסטר ותהליך להכנתו (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
Hong Kong	1181775	含磷活性物質的立體有擇合成 (STEREOSELECTIVE SYNTHESIS OF PHOSPHORUS CONTAINING ACTIVES)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for sofosbuvir

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2430014	2016C/006	Belgium	⤷ Sign Up	PRODUCT NAME: LEDIPASVIR/SOFOSBUVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 20141118
2203462	14C0082	France	⤷ Sign Up	PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2635588	C02635588/01	Switzerland	⤷ Sign Up	PRODUCT NAME: VELPATASVIR + SOFOSBUVIR + VOXILAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66510 08.12.2017
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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