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Last Updated: November 21, 2024

TENOFOVIR DISOPROXIL FUMARATE - Generic Drug Details


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What are the generic sources for tenofovir disoproxil fumarate and what is the scope of patent protection?

Tenofovir disoproxil fumarate is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc, Aurobindo Pharma, Chartwell, Chartwell Rx, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Norvium Bioscience, Qilu, Reyoung, Strides Pharma, and Teva Pharms Usa, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for tenofovir disoproxil fumarate. Sixteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for TENOFOVIR DISOPROXIL FUMARATE

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Recent Clinical Trials for TENOFOVIR DISOPROXIL FUMARATE

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

SponsorPhase
Wits Health Consortium (Pty) LtdPhase 3
London School of Hygiene and Tropical MedicinePhase 3
Africa Health Research InstitutePhase 3

See all TENOFOVIR DISOPROXIL FUMARATE clinical trials

Generic filers with tentative approvals for TENOFOVIR DISOPROXIL FUMARATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up300MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up250MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up200MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for TENOFOVIR DISOPROXIL FUMARATE
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 TENOFOVIR DISOPROXIL FUMARATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Macleods Pharms Ltd TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 203232-001 Jan 26, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd Iii TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090636-001 Jan 26, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 206481-001 Jul 26, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cipla TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 078800-001 Jan 26, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090647-001 Jan 26, 2018 AB RX No 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 TENOFOVIR DISOPROXIL FUMARATE

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
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-001 Oct 26, 2001 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.