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Last Updated: November 27, 2022

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, 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 twenty-seven 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

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SponsorPhase
Brenda HoaglandPhase 3
Valdilea GonçalvesPhase 3
Beatriz GrinsztejnPhase 3

See all tenofovir disoproxil fumarate clinical trials

Generic filers with tentative approvals for TENOFOVIR DISOPROXIL FUMARATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing300MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing300MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing250MGTABLET;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
Chartwell TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 206481-001 Jul 26, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hetero Labs Ltd Iii TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090636-001 Jan 26, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Qilu TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 209498-002 Mar 2, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Strides Pharma TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090742-001 Jan 26, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090647-004 Jan 26, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 090647-003 Jan 26, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cipla TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET;ORAL 078800-001 Jan 26, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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