BOCEPREVIR - Generic Drug Details
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What are the generic sources for boceprevir and what is the scope of freedom to operate?
Boceprevir
is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Boceprevir has one hundred and ten patent family members in thirty-three countries.
Summary for BOCEPREVIR
International Patents: | 110 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 54 |
Clinical Trials: | 72 |
Patent Applications: | 3,649 |
Formulation / Manufacturing: | see details |
DailyMed Link: | BOCEPREVIR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BOCEPREVIR
Generic Entry Date for BOCEPREVIR*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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 BOCEPREVIR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Dayanand Medical College and Hospital | |
American Research Corporation | Phase 4 |
Gilead Sciences | Phase 2/Phase 3 |
US Patents and Regulatory Information for BOCEPREVIR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Merck Sharp Dohme | VICTRELIS | boceprevir | CAPSULE;ORAL | 202258-001 | May 13, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Merck Sharp Dohme | VICTRELIS | boceprevir | CAPSULE;ORAL | 202258-001 | May 13, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Merck Sharp Dohme | VICTRELIS | boceprevir | CAPSULE;ORAL | 202258-001 | May 13, 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 BOCEPREVIR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck Sharp Dohme | VICTRELIS | boceprevir | CAPSULE;ORAL | 202258-001 | May 13, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for BOCEPREVIR
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Merck Sharp Dohme Ltd | Victrelis | boceprevir | EMEA/H/C/002332 Victrelis is indicated for the treatment of chronic hepatitis-C (CHC) genotype-1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. |
Withdrawn | no | no | no | 2011-07-18 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for BOCEPREVIR
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 1891089 | ⤷ Sign Up | |
Argentina | 033985 | PEPTIDOS INHIBIDORES DE PROTEASA SERINA-NS3 DEL VIRUS DE LA HEPATITIS C, COMPOSICION FARMACEUTICA QUE LOS COMPRENDE, UN METODO PARA SU PREPARACION, USO DE LOS MISMOS PARA LA FABRICACION DE UN MEDICAMENTO Y UN METODO DE MODULACION DE LA ACTIVIDAD DE LA PROTEASA DEL VIRUS DE LA HEPATITIS C | ⤷ Sign Up |
Australia | 2009210423 | ⤷ Sign Up | |
Slovakia | 752003 | Peptides as NS3-serine protease inhibitors of hepatitis C virus | ⤷ Sign Up |
Japan | 2008542383 | ⤷ Sign Up | |
Japan | 2012250996 | PHARMACEUTICAL FORMULATION AND METHOD OF TREATMENT USING THE SAME | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BOCEPREVIR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1385870 | 300506 | Netherlands | ⤷ Sign Up | PRODUCT NAME: BOCEPREVIR, OF EEN ENANTIOMEER, STEREOISIOMEER, ROTAMEER, TAUTOMEER OF RACEMAAT VAN DIE VERBINDING, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/11/704/001 20110718 |
1385870 | 1190037-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: BOCEPREVIR ELLER EN ENANTIOMER, STEREOISOMER, ROTAMER, TAUTOMER ELLER RACEMAT AV NAEMNDA FOERENING ELLER ETT FARMACEUTISKT GODTAGBART SALT ELLER SOLVAT AV NAEMNDA FOERENING; REG. NO/DATE: EU/1/11/704/001 20110718 |
1385870 | C01385870/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: BOCEPREVIR; REGISTRATION NO/DATE: SWISSMEDIC 62105 31.10.2011 |
1385870 | 410 | Finland | ⤷ Sign Up | |
1385870 | C300506 | Netherlands | ⤷ Sign Up | PRODUCT NAME: BOCEPREVIR, OF EEN ENANTIOMEER, STEREOISIOMEER, ROATMEER, TAUTOMEER OF RACEMAAT VAN DIE VERBINDING, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/11/704/001 20110718 |
1385870 | 2011/038 | Ireland | ⤷ Sign Up | PRODUCT NAME: BOCEPREVIR OR AN ENANTIOMER, STEREOISOMER, ROTAMER, TAUTOMER OR RACEMATE OF SAID COMPOUND OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE OF SAID COMPOUND; REGISTRATION NO/DATE: EU/1/11/704/001 20110718 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |