Emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details
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What are the generic sources for emtricitabine; tenofovir disoproxil fumarate and what is the scope of patent protection?
Emtricitabine; tenofovir disoproxil fumarate
is the generic ingredient in three branded drugs marketed by Hetero Labs Ltd Iii, Amneal Pharms Co, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Laurus, Macleods Pharms Ltd, Mylan, Strides Pharma, Teva Pharms Usa, Zydus Pharms, and Gilead, and is included in fourteen NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Emtricitabine; tenofovir disoproxil fumarate has sixty-two patent family members in twenty-nine countries.
Thirty-one suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for emtricitabine; tenofovir disoproxil fumarate
International Patents: | 62 |
US Patents: | 4 |
Tradenames: | 3 |
Applicants: | 14 |
NDAs: | 14 |
Finished Product Suppliers / Packagers: | 31 |
Clinical Trials: | 179 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for emtricitabine; tenofovir disoproxil fumarate |
DailyMed Link: | emtricitabine; tenofovir disoproxil fumarate at DailyMed |
Recent Clinical Trials for emtricitabine; tenofovir disoproxil fumarate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Desmond Tutu HIV Foundation | Phase 3 |
Wits Health Consortium (Pty) Ltd | Phase 3 |
London School of Hygiene and Tropical Medicine | Phase 3 |
See all emtricitabine; tenofovir disoproxil fumarate clinical trials
Generic filers with tentative approvals for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 200MG; 300MG | 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 emtricitabine; tenofovir disoproxil fumarate
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TRUVADA | Tablets | emtricitabine; tenofovir disoproxil fumarate | 100 mg/150 mg 133 mg/200 mg 167 mg/250 mg | 021752 | 1 | 2017-05-19 |
TRUVADA | Tablets | emtricitabine; tenofovir disoproxil fumarate | 200 mg/300 mg | 021752 | 1 | 2008-09-26 |
US Patents and Regulatory Information for emtricitabine; 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Macleods Pharms Ltd | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 203442-001 | May 15, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Strides Pharma | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 091055-001 | Jan 13, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-003 | Mar 10, 2016 | AB | RX | Yes | 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 emtricitabine; tenofovir disoproxil fumarate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-001 | Aug 2, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-002 | Mar 10, 2016 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | TRUVADA | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021752-001 | Aug 2, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for emtricitabine; tenofovir disoproxil fumarate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2512475 | COMPOSITIONS ET METHODES DESTINEES A UNE THERAPIE DE COMBINAISON ANTIVIRALE (COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY) | ⤷ Sign Up |
China | 102670629 | Compositions and methods for combination antiviral therapy | ⤷ Sign Up |
European Patent Office | 3025718 | COMPOSITIONS ET PROCÉDÉS POUR UNE THÉRAPIE ANTIVIRALE COMBINÉE (COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for emtricitabine; tenofovir disoproxil fumarate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1663240 | 1690062-3 | Sweden | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623 |
1663240 | 2016/058 | Ireland | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A THERAPEUTICALLY EQUIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE.; NAT REGISTRATION NO/DATE: EU/1/16/1112 20160621; FIRST REGISTRATION NO/DATE: JOURNAL OF THE INTELLECTUAL PROPERTY OFFICE OF IRELAND (NO. 2457) |
1663240 | 2015/053 | Ireland | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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