Boceprevir - Generic Drug Details
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What are the generic sources for boceprevir and what is the scope of patent protection?
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 |
Icahn School of Medicine at Mount Sinai | Phase 2/Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for boceprevir
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Merck Sharp Dohme | VICTRELIS | boceprevir | CAPSULE;ORAL | 202258-001 | May 13, 2011 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Merck Sharp Dohme | VICTRELIS | boceprevir | CAPSULE;ORAL | 202258-001 | May 13, 2011 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 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 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2006130686 | ⤷ Try a Trial | |
Peru | 20030852 | PEPTIDOS COMO INHIBIDORES DE LA PROTEASA SERINA NS3 DEL VIRUS DE LA HEPATITIS C | ⤷ Try a Trial |
Brazil | 0112540 | ⤷ Try a Trial | |
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 | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for boceprevir
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1385870 | 410 | Finland | ⤷ Try a Trial | |
1385870 | 2011/038 | Ireland | ⤷ Try a Trial | 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 |
1385870 | C 2011 014 | Romania | ⤷ Try a Trial | PRODUCT NAME: BOCEPREVIR(1R,2S,5S)-N-[3-AMINO-1-(CICLOBUTILMETIL)-2,3-DIOXOPROPIL]-3-[(2S)-2[[[(1,1-DIMETILETIL)AMINO]CARBONIL]AMINO]-3,3-DIMETIL-1-OXOBUTIL]-6,6-DIMETIL-3-AZABICICLO[3.1.0]HEXAN-2-CARBOXAMIDA; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/704/001; DATE OF NATIONAL AUTHORISATION: 20110718; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/704/001; DATE OF FIRST AUTHORISATION IN EEA: 20110718 |
1385870 | 1190037-0 | Sweden | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |