TENOFOVIR DISOPROXIL FUMARATE Drug Patent Profile
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When do Tenofovir Disoproxil Fumarate patents expire, and when can generic versions of Tenofovir Disoproxil Fumarate launch?
Tenofovir Disoproxil Fumarate is a drug marketed by 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 twelve NDAs.
The generic ingredient in TENOFOVIR DISOPROXIL FUMARATE is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tenofovir Disoproxil Fumarate
A generic version of TENOFOVIR DISOPROXIL FUMARATE was approved as tenofovir disoproxil fumarate by TEVA PHARMS USA on March 18th, 2015.
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Questions you can ask:
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Summary for TENOFOVIR DISOPROXIL FUMARATE
Recent Clinical Trials for TENOFOVIR DISOPROXIL FUMARATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Phase 3 |
| Wits Health Consortium (Pty) Ltd | Phase 3 |
| London School of Hygiene and Tropical Medicine | Phase 3 |
Pharmacology for TENOFOVIR DISOPROXIL FUMARATE
Anatomical Therapeutic Chemical (ATC) Classes for TENOFOVIR DISOPROXIL FUMARATE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| Reyoung | TENOFOVIR DISOPROXIL FUMARATE | tenofovir disoproxil fumarate | TABLET;ORAL | 211337-001 | Mar 2, 2023 | 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
