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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.
Summary for tenofovir disoproxil fumarate
Recent Clinical Trials for tenofovir disoproxil fumarate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
NIH-NICHD | Phase 3 |
University of Alabama at Birmingham | Phase 3 |
University Health Network, Toronto | Phase 4 |
Generic filers with tentative approvals for TENOFOVIR DISOPROXIL FUMARATE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 300MG | TABLET; ORAL |
Start Trial | Start Trial | 300MG | TABLET;ORAL |
Start Trial | Start Trial | 200MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology 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
Expired US Patents for tenofovir disoproxil fumarate
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