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, Mylan Labs 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.
Summary for TENOFOVIR DISOPROXIL FUMARATE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 13 |
NDAs: | 14 |
Drug Master File Entries: | 27 |
Finished Product Suppliers / Packagers: | 16 |
Raw Ingredient (Bulk) Api Vendors: | 89 |
Clinical Trials: | 394 |
Patent Applications: | 6,694 |
Drug Prices: | Drug price trends for TENOFOVIR DISOPROXIL FUMARATE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TENOFOVIR DISOPROXIL FUMARATE |
What excipients (inactive ingredients) are in TENOFOVIR DISOPROXIL FUMARATE? | TENOFOVIR DISOPROXIL FUMARATE excipients list |
DailyMed Link: | TENOFOVIR DISOPROXIL FUMARATE at DailyMed |
Recent Clinical Trials for TENOFOVIR DISOPROXIL FUMARATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University College, London | Phase 3 |
King's College London | Phase 3 |
MRC/UVRI and LSHTM Uganda Research Unit | Phase 3 |
Generic filers with tentative approvals for TENOFOVIR DISOPROXIL FUMARATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 300MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 250MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 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 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Norvium Bioscience | TENOFOVIR DISOPROXIL FUMARATE | tenofovir disoproxil fumarate | TABLET;ORAL | 206569-003 | Nov 27, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Qilu | TENOFOVIR DISOPROXIL FUMARATE | tenofovir disoproxil fumarate | TABLET;ORAL | 209498-001 | Mar 2, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms Usa | TENOFOVIR DISOPROXIL FUMARATE | tenofovir disoproxil fumarate | TABLET;ORAL | 091612-004 | 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 | |||
>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 | POWDER;ORAL | 022577-001 | 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 | TABLET;ORAL | 021356-001 | Oct 26, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences Inc | VIREAD | tenofovir disoproxil fumarate | POWDER;ORAL | 022577-001 | Jan 18, 2012 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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