VIREAD Drug Patent Profile

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When do Viread patents expire, and when can generic versions of Viread launch?

Viread is a drug marketed by Gilead Sciences Inc and is included in two NDAs.

The generic ingredient in VIREAD is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Viread

A generic version of VIREAD was approved as tenofovir disoproxil fumarate by TEVA PHARMS USA on March 18^th, 2015.

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Summary for VIREAD

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	91
Patent Applications:	4,317
Drug Prices:	Drug price information for VIREAD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIREAD
What excipients (inactive ingredients) are in VIREAD?	VIREAD excipients list
DailyMed Link:	VIREAD at DailyMed

Drug patent expirations by year for VIREAD

Recent Clinical Trials for VIREAD

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

Sponsor	Phase
Albert Einstein College of Medicine	Phase 4
Université Protestant au Congo	Phase 4
Doris Duke Charitable Foundation	Phase 4

See all VIREAD clinical trials

Pharmacology for VIREAD

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Paragraph IV (Patent) Challenges for VIREAD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIREAD	Tablets	tenofovir disoproxil fumarate	150 mg, 200 mg, and 250 mg	021356	1	2012-05-17
VIREAD	Tablets	tenofovir disoproxil fumarate	300 mg	021356	1	2010-01-26

US Patents and Regulatory Information for VIREAD

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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	VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577-001	Jan 18, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-004	Jan 18, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012	AB	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

Expired US Patents for VIREAD

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-004	Jan 18, 2012	⤷ Sign Up	⤷ Sign Up
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-004	Jan 18, 2012	⤷ Sign Up	⤷ Sign Up
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012	⤷ Sign Up	⤷ Sign Up
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577-001	Jan 18, 2012	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for VIREAD

See the table below for patents covering VIREAD around the world.

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Country	Patent Number	Title	Estimated Expiration
Czechoslovakia	263951	9-(PHOSPONYLMETHOXYALKYL)ADENINES AND METHOD OF THEIR PREPARATION	⤷ Sign Up
Hong Kong	213296	9-(phosphonyl-methoxyalkyl) adenines method for their preparation and their use	⤷ Sign Up
Germany	122005000041		⤷ Sign Up
Hong Kong	1051360		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VIREAD

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0915894	05C0032	France	⤷ Sign Up	PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
1663240	1690061-5	Sweden	⤷ Sign Up	PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623
1663240	300851	Netherlands	⤷ Sign Up	PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
2924034	122019000042	Germany	⤷ Sign Up	PRODUCT NAME: DORAVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON IN KOMBINATION MIT LAMIVUDIN UND TENOFOVIR-DISOPROXIL-FUMARAT; REGISTRATION NO/DATE: EU/1/18/1333 20181122
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description