Elbasvir; grazoprevir - Generic Drug Details
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What are the generic sources for elbasvir; grazoprevir and what is the scope of freedom to operate?
Elbasvir; grazoprevir
is the generic ingredient in one branded drug marketed by Msd Sub Merck and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Elbasvir; grazoprevir has one hundred and twelve patent family members in forty-six countries.
One supplier is listed for this compound.
Summary for elbasvir; grazoprevir
International Patents: | 112 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 62 |
DailyMed Link: | elbasvir; grazoprevir at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for elbasvir; grazoprevir
Generic Entry Date for elbasvir; grazoprevir*:
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 elbasvir; grazoprevir
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Cairo University | Phase 4 |
University of Pennsylvania | Phase 4 |
Austin Hospital, Melbourne Australia | Phase 3 |
Pharmacology for elbasvir; grazoprevir
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Msd Sub Merck | ZEPATIER | elbasvir; grazoprevir | TABLET;ORAL | 208261-001 | Jan 28, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Msd Sub Merck | ZEPATIER | elbasvir; grazoprevir | TABLET;ORAL | 208261-001 | Jan 28, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Msd Sub Merck | ZEPATIER | elbasvir; grazoprevir | TABLET;ORAL | 208261-001 | Jan 28, 2016 | RX | Yes | Yes | ⤷ 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 |
EU/EMA Drug Approvals for elbasvir; grazoprevir
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Merck Sharp & Dohme B.V. | Zepatier | elbasvir, grazoprevir | EMEA/H/C/004126 ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1. |
Authorised | no | no | no | 2016-07-22 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for elbasvir; grazoprevir
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 2540350 | ⤷ Try a Trial | |
Georgia, Republic of | P20146134 | INHIBITORS OF HEPATITIS C VIRUS REPLICATION | ⤷ Try a Trial |
New Zealand | 595410 | Inhibitors of hepatitis c virus replication | ⤷ Try a Trial |
Japan | 5913091 | ⤷ Try a Trial | |
Japan | 2011528713 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for elbasvir; grazoprevir
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2410844 | C02410844/01 | Switzerland | ⤷ Try a Trial | FUSION; FORMER OWNER: MERCK SHARP AND DOHME CORP., US |
2410844 | C20160050 00207 | Estonia | ⤷ Try a Trial | PRODUCT NAME: ELBASVIIR;REG NO/DATE: EU/1/16/1119 26.07.2016 |
2410844 | C20160050 | Estonia | ⤷ Try a Trial | (93) SZ 65861 01, 01.04.2016 (93) CH 65861 01, 01.04.2016 |
2310095 | PA2016049,C2310095 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: GRAZOPREVIRAS ARBA FARMACISKAI PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/16/1119 20160722 |
2410844 | 122017000001 | Germany | ⤷ Try a Trial | PRODUCT NAME: ELBASVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1119 20160722 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.