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Last Updated: August 10, 2020

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Tenofovir disoproxil fumarate - Generic Drug Details

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

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

There are forty-two drug master file entries for tenofovir disoproxil fumarate. Sixteen suppliers are listed for this compound. There are five 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
Augusta UniversityPhase 4
Rhonda BrandEarly Phase 1
Effice Servicios Para la Investigacion S.L.Phase 3

See all tenofovir disoproxil fumarate clinical trials

Generic filers with tentative approvals for TENOFOVIR DISOPROXIL FUMARATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial300MGTABLET; ORAL
  Start Trial  Start Trial300MGTABLET;ORAL
  Start Trial  Start Trial250MGTABLET;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 NDA Submissiondate
VIREAD TABLET;ORAL tenofovir disoproxil fumarate 021356 2012-05-17
VIREAD TABLET;ORAL tenofovir disoproxil fumarate 021356 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
Aurobindo Pharma Ltd TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090647-003 Jan 26, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-004 Jan 18, 2012 AB RX Yes No   Start Trial   Start Trial   Start Trial
Mylan TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 206569-002 Nov 27, 2018 DISCN No No   Start Trial   Start Trial   Start 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 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   Start Trial   Start Trial
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-001 Oct 26, 2001   Start Trial   Start Trial
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-003 Jan 18, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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