OMBITASVIR; PARITAPREVIR; RITONAVIR - Generic Drug Details
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What are the generic 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 fifty patent family members in forty-eight countries.
Summary for OMBITASVIR; PARITAPREVIR; RITONAVIR
| International Patents: | 450 |
| 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 |
|---|---|
| Sohag University | Phase 4 |
| Assiut University | Phase 4 |
| South Valley 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 | 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 | |||
| 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 | |||
| >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 |
|---|---|---|---|
| Serbia | 52854 | INHIBITORI HEPATITIS C VIRUSA (HEPATITIS C VIRUS INHIBITORS) | ⤷ Try a Trial |
| Taiwan | I381840 | ⤷ Try a Trial | |
| South Korea | 101487726 | ⤷ Try a Trial | |
| Israel | 211792 | דימתיל (2s,2's)-1,'1-((2s,2's)-2,'2-(4,'4-((2s,5s)-1-(4-טרט-בוטילפניל)פירולידין-5,2-דיאיל)ביס(1,4 פנילן))ביס (אזאנדיאיל)ביס(אוקסומתילן)ביס(פירולידין-1,2-דיאיל))ביס(3- מתיל-1-אוקסובוטן-1,2-דיאיל)דיקארבמאט והרכב רוקחי המכיל אותו (Dimethyl (2s, 2's)-1, 1'-((2s,2's)-2,2'-(4,4' -((2s,5s)-1 -(4-tert-butylphenyl) pyrrolidine-2,5 -diyl) bis (4,1 phenylene)) bis (azanediyl) bis (oxomethylene) bis (pyrrolidine-2,1-diyl)) bis (3-methyl-1-oxobutane-2,1 -diyl) dicarbamate and a pharmaceutical composition comprising same) | ⤷ Try a Trial |
| New Zealand | 560829 | A solid pharmaceutical dosage formulation | ⤷ Try a Trial |
| Portugal | 2954892 | ⤷ 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 | 1790050-7/1791051-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF. |
| 2692346 | CR 2017 00049 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/17/1213 20170728 |
| 2692346 | SPC/GB17/056 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/17/1213 (NI) 20170728; UK PLGB 41042/0030 20170728; UK PLGB 41042/0043 20170728 |
| 2692346 | 17C1040 | France | ⤷ Try a Trial | PRODUCT NAME: PIBRENTASVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/17/1213 20170728 |
| 2692346 | 132017000122534 | Italy | ⤷ Try a Trial | PRODUCT NAME: PIBRENTASVIR, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(MAVIRET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1213, 20170728 |
| 2692346 | 299 50017-2017 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: PIBRENTASVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1213 20170728 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
