Boceprevir - Generic Drug Details
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What are the generic drug 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 |
| Icahn School of Medicine at Mount Sinai | 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 | ⤷ Try a Trial | ⤷ Try a Trial | 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 | 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 | ⤷ 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 |
|---|---|---|---|
| Russian Federation | 2355700 | НОВЫЕ ПЕПТИДЫ КАК ИНГИБИТОРЫ NS3-СЕРИНПРОТЕАЗЫ ВИРУСА ГЕПАТИТА С (NOVEL PEPTIDES AS INHIBITORS OF HEPATITIS C VIRUS NS3 SERINE PROTEASE) | ⤷ Try a Trial |
| Poland | 1891089 | ⤷ Try a Trial | |
| Taiwan | 200307691 | ⤷ Try a Trial | |
| Taiwan | I324611 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 03062265 | ⤷ Try a Trial | |
| Taiwan | I428138 | ⤷ Try a Trial | |
| Spain | 2572980 | ⤷ 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 | 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 | C01385870/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: BOCEPREVIR; REGISTRATION NO/DATE: SWISSMEDIC 62105 31.10.2011 |
| 1385870 | SPC/GB11/057 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: BOCEPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/704/001 20110720 |
| 1385870 | 300506 | Netherlands | ⤷ Try a Trial | 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 | C300506 | Netherlands | ⤷ Try a Trial | 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 | 12C0002 | France | ⤷ Try a Trial | PRODUCT NAME: BOCEPREVIR OU UN ENANTIOMERE, STEREOISOMERE, ROTAMERE, TAUTOMERE OU RACEMATE DUDIT COMPOSE, OU UN DE SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/704/001 20110718 |
| 1385870 | CA 2011 00036 | Denmark | ⤷ Try a Trial | PRODUCT NAME: BOCEPREVIR ELLER EN ENANTIOMER, EN STEREOISOMER, EN ROTAMER, EN TAUTOMER ELLER ET RACEMAT AF DENNE FORBINDELSE, ELLER FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT AF DENNE FORBINDEL |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
