TELAPREVIR - Generic Drug Details
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What are the generic 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
Generic Entry Date for TELAPREVIR*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Vertex Pharms | INCIVEK | telaprevir | TABLET;ORAL | 201917-001 | May 23, 2011 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| European Patent Office | 1876173 | ⤷ Try a Trial | |
| China | 1869061 | ⤷ Try a Trial | |
| China | 101696232 | ⤷ Try a Trial | |
| South Korea | 20080096718 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TELAPREVIR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1320540 | 122012000015 | Germany | ⤷ Try a Trial | PRODUCT NAME: TELAPREVIR UND JEDE THERAPEUTISCH AEQUIVALENTE FORM DAVON, WELCHE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE PHARMAZEUTISCH VERTRAEGLICHE SALZE UND/ODER SOLVATE VON TELAPREVIR ODER SOLVATE SOLCHER SALZE.; REGISTRATION NO/DATE: EU/1/11/720/001 20110919 |
| 1320540 | 91960 | Luxembourg | ⤷ Try a Trial | 91960, EXPIRES: 20260831 |
| 1320540 | CA 2012 00007 | Denmark | ⤷ Try a Trial | |
| 1320540 | CR 2012 00007 | Denmark | ⤷ Try a Trial | PRODUCT NAME: TELAPREVIR OG FARMACEUTISK ACCEPTABLE SALTE OG/ELLER SOLVATER AF TELAPREVIR ELLER SOLVATER AF SADANNE SALTE; REG. NO/DATE: EU/1/11/720/001 20110919 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
