ETRAVIRINE Drug Patent Profile
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Which patents cover Etravirine, and what generic alternatives are available?
Etravirine is a drug marketed by Amneal and Carnegie and is included in two NDAs.
The generic ingredient in ETRAVIRINE is etravirine. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the etravirine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Etravirine
A generic version of ETRAVIRINE was approved as etravirine by AMNEAL on June 14th, 2021.
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Questions you can ask:
- What is the 5 year forecast for ETRAVIRINE?
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- What is Average Wholesale Price for ETRAVIRINE?
Summary for ETRAVIRINE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 120 |
| Clinical Trials: | 54 |
| Patent Applications: | 4,021 |
| Drug Prices: | Drug price information for ETRAVIRINE |
| DailyMed Link: | ETRAVIRINE at DailyMed |
Recent Clinical Trials for ETRAVIRINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fundacion Clinic per a la Recerca Biomédica | Phase 4 |
| Jean-Pierre Routy | N/A |
| Orlando Immunology Center | Phase 4 |
Pharmacology for ETRAVIRINE
Anatomical Therapeutic Chemical (ATC) Classes for ETRAVIRINE
US Patents and Regulatory Information for ETRAVIRINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | ETRAVIRINE | etravirine | TABLET;ORAL | 214196-001 | Jun 14, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Carnegie | ETRAVIRINE | etravirine | TABLET;ORAL | 215402-001 | Apr 13, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Amneal | ETRAVIRINE | etravirine | TABLET;ORAL | 214196-002 | Jun 14, 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 ETRAVIRINE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Janssen-Cilag International NV | Intelence | etravirine | EMEA/H/C/000900 Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age.This indication is based on week-48 analyses from two phase-III trials in highly pretreated patients where Intelence was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, phase-II trial in antiretroviral-treatment-experienced paediatric patients. |
Authorised | no | no | no | 2008-08-28 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
