OMBITASVIR; PARITAPREVIR; RITONAVIR - Generic Drug Details
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What are the generic drug sources for ombitasvir; paritaprevir; ritonavir and what is the scope of patent protection?
Ombitasvir; paritaprevir; ritonavir
is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ombitasvir; paritaprevir; ritonavir has four hundred and forty-nine patent family members in forty-eight countries.
Summary for OMBITASVIR; PARITAPREVIR; RITONAVIR
| International Patents: | 449 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 41 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OMBITASVIR; PARITAPREVIR; RITONAVIR |
| DailyMed Link: | OMBITASVIR; PARITAPREVIR; RITONAVIR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OMBITASVIR; PARITAPREVIR; RITONAVIR
Generic Entry Date for OMBITASVIR; PARITAPREVIR; RITONAVIR*:
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 OMBITASVIR; PARITAPREVIR; RITONAVIR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| South Valley University | Phase 4 |
| Sohag University | Phase 4 |
| Assiut University | Phase 4 |
US Patents and Regulatory Information for OMBITASVIR; PARITAPREVIR; RITONAVIR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | TECHNIVIE | ombitasvir; paritaprevir; ritonavir | TABLET;ORAL | 207931-001 | Jul 24, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Abbvie | TECHNIVIE | ombitasvir; paritaprevir; ritonavir | TABLET;ORAL | 207931-001 | Jul 24, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Abbvie | TECHNIVIE | ombitasvir; paritaprevir; ritonavir | TABLET;ORAL | 207931-001 | Jul 24, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Abbvie | TECHNIVIE | ombitasvir; paritaprevir; ritonavir | TABLET;ORAL | 207931-001 | Jul 24, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Abbvie | TECHNIVIE | ombitasvir; paritaprevir; ritonavir | TABLET;ORAL | 207931-001 | Jul 24, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Abbvie | TECHNIVIE | ombitasvir; paritaprevir; ritonavir | TABLET;ORAL | 207931-001 | Jul 24, 2015 | DISCN | Yes | 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 OMBITASVIR; PARITAPREVIR; RITONAVIR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | TECHNIVIE | ombitasvir; paritaprevir; ritonavir | TABLET;ORAL | 207931-001 | Jul 24, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | TECHNIVIE | ombitasvir; paritaprevir; ritonavir | TABLET;ORAL | 207931-001 | Jul 24, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | TECHNIVIE | ombitasvir; paritaprevir; ritonavir | TABLET;ORAL | 207931-001 | Jul 24, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | TECHNIVIE | ombitasvir; paritaprevir; ritonavir | TABLET;ORAL | 207931-001 | Jul 24, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for OMBITASVIR; PARITAPREVIR; RITONAVIR
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| AbbVie Deutschland GmbH Co. KG | Viekirax | ombitasvir, paritaprevir, ritonavir | EMEA/H/C/003839 Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.For hepatitis C virus (HCV) genotype specific activity. |
Authorised | no | no | no | 2015-01-14 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for OMBITASVIR; PARITAPREVIR; RITONAVIR
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Guatemala | 200600295 | UNA FORMULACION SOLIDA DE DOSIFICACION FARMACEUTICA | ⤷ Try a Trial |
| Guatemala | 201100074 | COMPUESTOS ANTIVIRALES | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2010144646 | ⤷ Try a Trial | |
| Eurasian Patent Organization | 024538 | ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ СОЕДИНЕНИЕ С АНТИ-ВГС (HCV) АКТИВНОСТЬЮ (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A COMPOUND WITH ANTI-HCV ACTIVITY) | ⤷ Try a Trial |
| Dominican Republic | P2011000087 | Compuestos eficaces para inhibir la replicación del virus de la hepatitis c("HCV") | ⤷ Try a Trial |
| South Korea | 20130053440 | 고체 조성물 (SOLID COMPOSITIONS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OMBITASVIR; PARITAPREVIR; RITONAVIR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2692346 | PA2017033,C2692346 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: PIBRENTASVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/17/1213 20170726 |
| 2340029 | C02340029/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: PARITAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC 65301 25.11.2014 |
| 2692346 | C20170036 00243 | Estonia | ⤷ Try a Trial | PRODUCT NAME: PIBRENTASVIIR;REG NO/DATE: EU/1/17/1213 28.07.2017 |
| 2340029 | CR 2015 00013 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PARITAPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEROF; REG. NO/DATE: EU/1/14/982 20150119 |
| 2340029 | C 2015 019 | Romania | ⤷ Try a Trial | PRODUCT NAME: PARITAPREVIR; NATIONAL AUTHORISATION NUMBER: EU/1/14/982; DATE OF NATIONAL AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/982; DATE OF FIRST AUTHORISATION IN EEA: 20150115 |
| 2340029 | 300730 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PARITAPREVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; REGISTRATION NO/DATE: EU/1/14/982 20150119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
