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 freedom to operate?
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 |
|---|---|
| Assiut University | Phase 4 |
| South Valley University | Phase 4 |
| Sohag 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 | ⤷ 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 | |||
| 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 | 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 |
|---|---|---|---|
| Lithuania | C2340029 | ⤷ Try a Trial | |
| European Patent Office | 2954892 | COMPOSITIONS SOLIDES (SOLID COMPOSITIONS) | ⤷ Try a Trial |
| Turkey | 201809771 | ⤷ Try a Trial | |
| Colombia | 6761348 | Compuestos antivirales | ⤷ Try a Trial |
| Norway | 2017057 | ⤷ 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 |
|---|---|---|---|---|
| 2368890 | SPC/GB15/015 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: OMBITASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/14/982 20150119 |
| 2692346 | LUC00038 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: PIBRENTASVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1213 20170728 |
| 2692346 | 300901 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PIBRENTASVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/17/1213 20170728 |
| 2368890 | 92668 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: OMBITASVIR, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE (VIEKIRAX R); FIRST REGISTRATION DATE: 20150119 |
| 2368890 | C20150016 00154 | Estonia | ⤷ Try a Trial | PRODUCT NAME: OMBITASVIIR;REG NO/DATE: EU/1/14/982 19.01.2015 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
