Telaprevir - Generic Drug Details
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What are the generic drug sources for telaprevir and what is the scope of freedom to operate?
Telaprevir
is the generic ingredient in one branded drug marketed by Vertex Pharms and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Telaprevir has one hundred and twenty-four patent family members in thirty-eight countries.
There are three drug master file entries for telaprevir.
Summary for telaprevir
| International Patents: | 124 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 85 |
| Clinical Trials: | 103 |
| Patent Applications: | 3,978 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | telaprevir at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for telaprevir
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for telaprevir
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Merck Sharp & Dohme Corp. | Phase 4 |
| National Taiwan University Hospital | Phase 4 |
| Dayanand Medical College and Hospital |
Anatomical Therapeutic Chemical (ATC) Classes for telaprevir
US Patents and Regulatory Information for telaprevir
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vertex Pharms | INCIVEK | telaprevir | TABLET;ORAL | 201917-001 | May 23, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Vertex Pharms | INCIVEK | telaprevir | TABLET;ORAL | 201917-001 | May 23, 2011 | DISCN | 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 telaprevir
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vertex Pharms | INCIVEK | telaprevir | TABLET;ORAL | 201917-001 | May 23, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for telaprevir
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Janssen-Cilag International N.V. | Incivo | telaprevir | EMEA/H/C/002313 Incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis):who are treatment naïve;who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders. |
Withdrawn | no | no | no | 2011-09-19 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for telaprevir
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Taiwan | I319763 | ⤷ Sign Up | |
| Austria | 431358 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2006050250 | ⤷ Sign Up | |
| Algeria | 3438 | INHIBITEURS PEPTIDOMIMETIQUES DE PROTEASE | ⤷ Sign Up |
| Ukraine | 99895 | ПЕПТИДОМІМЕТИЧНИЙ ІНГІБІТОР ПРОТЕАЗ[ПЕПТИДОМИМЕТИЧЕСКИЙ ИНГИБИТОР ПРОТЕАЗ (PEPTIDOMIMETIC PROTEASE INHIBITOR) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for telaprevir
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1320540 | PA2012003,C1320540 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TELAPREVIRUM; REGISTRATION NO/DATE: EU/1/11/720/001 20110919 |
| 1320540 | SPC/GB12/010 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TELAPREVIR OR PHARMACEUTICALLY ACCEPTABLE SALTS AND/OR SOLVATES OF TELAPREVIR OR SOLVATES OF SUCH SALTS.; REGISTERED: UK EU/1/11/720/001 20110919 |
| 1320540 | 12C0018 | France | ⤷ Sign Up | PRODUCT NAME: TELAPREVIR ET LES SELS ET/OU LES SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES DU TELAPREVIR OU LES SOLVATES DE TELS SELS; REGISTRATION NO/DATE: EU/1/11/720/001 20110919 |
| 1320540 | 91960 | Luxembourg | ⤷ Sign Up | 91960, EXPIRES: 20260831 |
| 1320540 | 1290007-2 | Sweden | ⤷ Sign Up | PRODUCT NAME: TELAPREVIR OCH FARMACEUTISKT GODTAGBARA SALTER OCH/ELLER SOLVAT AV TELAPREVIR ELLER SOLVAT AV SADANA SALTER; REG. NO/DATE: EU/1/11/720/001 20110919 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
