EMTRICITABINE - Generic Drug Details
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What are the generic sources for emtricitabine and what is the scope of patent protection?
Emtricitabine
is the generic ingredient in nine branded drugs marketed by Aurobindo Pharma Ltd, Cipla, Gilead, Gilead Sciences Inc, Apotex, Hetero Labs Ltd Iii, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, Laurus, Macleods Pharms Ltd, Mylan, Strides Pharma, Teva Pharms Usa, and Zydus Pharms, and is included in twenty-two NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are eighteen drug master file entries for emtricitabine. Three suppliers are listed for this compound. There are eight tentative approvals for this compound.
Summary for EMTRICITABINE
US Patents: | 10 |
Tradenames: | 9 |
Applicants: | 15 |
NDAs: | 22 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 139 |
Clinical Trials: | 505 |
Patent Applications: | 6,710 |
Drug Prices: | Drug price trends for EMTRICITABINE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EMTRICITABINE |
What excipients (inactive ingredients) are in EMTRICITABINE? | EMTRICITABINE excipients list |
DailyMed Link: | EMTRICITABINE at DailyMed |
Recent Clinical Trials for EMTRICITABINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
King's College London | Phase 3 |
Wits Health Consortium (Pty) Ltd | Phase 3 |
Desmond Tutu HIV Foundation | Phase 3 |
Generic filers with tentative approvals for EMTRICITABINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 200MG; 300MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 200MG | CAPSULE; ORAL |
⤷ Sign Up | ⤷ Sign Up | 200MG;300MG;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 EMTRICITABINE
Drug Class | Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for EMTRICITABINE
Anatomical Therapeutic Chemical (ATC) Classes for EMTRICITABINE
Paragraph IV (Patent) Challenges for EMTRICITABINE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EMTRIVA | Capsules | emtricitabine | 200 mg | 021500 | 1 | 2012-07-16 |
US Patents and Regulatory Information for EMTRICITABINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Inc | COMPLERA | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | TABLET;ORAL | 202123-001 | Aug 10, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Gilead Sciences Inc | DESCOVY | emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 208215-002 | Jan 7, 2022 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Aurobindo Pharma | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 090513-001 | 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 EMTRICITABINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead | EMTRIVA | emtricitabine | CAPSULE;ORAL | 021500-001 | Jul 2, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | EMTRIVA | emtricitabine | CAPSULE;ORAL | 021500-001 | Jul 2, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | EMTRIVA | emtricitabine | SOLUTION;ORAL | 021896-001 | Sep 28, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for EMTRICITABINE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Ireland UC | Emtriva | emtricitabine | EMEA/H/C/000533 Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens.When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate. |
Authorised | no | no | no | 2003-10-24 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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