EMTRICITABINE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Emtricitabine, and when can generic versions of Emtricitabine launch?
Emtricitabine is a drug marketed by Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Apotex, Amneal Pharms Co, Aurobindo Pharma, Chartwell Rx, Laurus, Macleods Pharms Ltd, Mylan, Strides Pharma, Teva Pharms Usa, and Zydus Pharms. and is included in sixteen NDAs.
The generic ingredient in EMTRICITABINE is emtricitabine; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the emtricitabine; tenofovir alafenamide fumarate profile page.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for EMTRICITABINE?
- What are the global sales for EMTRICITABINE?
- What is Average Wholesale Price for EMTRICITABINE?
Summary for EMTRICITABINE
Recent Clinical Trials for EMTRICITABINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wits Health Consortium (Pty) Ltd | Phase 3 |
| Desmond Tutu HIV Foundation | Phase 3 |
| Ministry of Health, Uganda | Phase 3 |
Pharmacology for EMTRICITABINE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | EMTRICITABINE | emtricitabine | CAPSULE;ORAL | 079188-001 | Mar 15, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| 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 | |||
| Zydus Pharms | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 212689-004 | Jul 1, 2021 | 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 |
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 |
