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 |
---|---|
Université Protestant au Congo | Phase 4 |
Doris Duke Charitable Foundation | Phase 4 |
Albert Einstein College of Medicine | 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 | |||
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-003 | 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 | 021356-003 | Jan 18, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | POWDER;ORAL | 022577-001 | Jan 18, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | TABLET;ORAL | 021356-003 | 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 |
---|---|---|---|
Portugal | 998480 | ⤷ Try a Trial | |
Netherlands | 300202 | ⤷ Try a Trial | |
Canada | 2574904 | ANALOGUES DE NUCLEOTIDES ENANTIOMERES ANTIRETROVIRAUX (ANTIRETROVIRAL ENANTIOMERIC NUCLEOTIDE ANALOGS) | ⤷ Try a Trial |
Japan | 2010280694 | NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD | ⤷ 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 | 132016000024787 | Italy | ⤷ Try a Trial | PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO, TENOFOVIR, IN PARTICOLARE TENOFOVIR DISOPROXIL FUMARATO E EMITRICITABINA(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128 |
1663240 | 223 5021-2015 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: EMTRICITABIN/RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128 |
1301519 | C01301519/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TENOFOVIRALAFENAMID; REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 65793 01.09.2016 |
1663240 | 92854 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE, ET TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |