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. Fifteen 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 18th, 2015.
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 |
Formulation / Manufacturing: | see details |
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 |
Recent Clinical Trials for VIREAD
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Doris Duke Charitable Foundation | Phase 4 |
Albert Einstein College of Medicine | Phase 4 |
Université Protestant au Congo | Phase 4 |
Pharmacology for VIREAD
Anatomical Therapeutic Chemical (ATC) Classes for VIREAD
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
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-004 | Jan 18, 2012 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-002 | Jan 18, 2012 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-002 | Jan 18, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-004 | Jan 18, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1251679 | ⤷ Try a Trial | |
Slovenia | 1243593 | ⤷ Try a Trial | |
Germany | 69829010 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VIREAD
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1663240 | 122015000087 | Germany | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
2924034 | C201930027 | Spain | ⤷ Try a Trial | PRODUCT NAME: DORAVIRINA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA EN COMBINACION CON LAMIVUDINA Y TENOFOVIR DISOPROXILO FUMARATO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1333; DATE OF AUTHORISATION: 20181122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1333; DATE OF FIRST AUTHORISATION IN EEA: 20181122 |
1301519 | PA2016009,C1301519 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS ARBA JO DRUSKA ARBA SOLVATAS, YPATINGAI TENOFOVIRO ALAFENAMIDO FUMARATAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |