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 thirteen patent family members in forty-six countries.
One supplier is listed for this compound.
Summary for ELBASVIR; GRAZOPREVIR
International Patents: | 113 |
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 |
Bayside Health | 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Msd Sub Merck | ZEPATIER | elbasvir; grazoprevir | TABLET;ORAL | 208261-001 | Jan 28, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Msd Sub Merck | ZEPATIER | elbasvir; grazoprevir | TABLET;ORAL | 208261-001 | Jan 28, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>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 |
---|---|---|---|
Lithuania | PA2016048 | ⤷ Sign Up | |
Singapore | 174929 | INHIBITORS OF HEPATITIS C VIRUS REPLICATION | ⤷ Sign Up |
South Korea | 20130140219 | INHIBITORS OF HEPATITIS C VIRUS REPLICATION | ⤷ Sign Up |
China | 103880862 | Inhibitors Of Hepatitis C Virus Replication | ⤷ Sign Up |
Hong Kong | 1173402 | PHARMACEUTICAL COMPOSITIONS COMPRISING A MACROCYCLIC QUINOXALINE COMPOUND WHICH IS AN HCV NS3 PROTEASE INHIBITOR | ⤷ Sign Up |
Ecuador | SP11011357 | INHIBIDORES DE LA REPLICACIÓN DEL VIRUS DE LA HEPATITIS C | ⤷ Sign Up |
Ecuador | SP11010777 | COMPUESTOS MACROCÍCLICOS DE QUINOXALINA COMO INHIBIDORES DE LA PROTEASA NS3 DE HCV | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ELBASVIR; GRAZOPREVIR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2310095 | SPC/GB17/014 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: GRAZOPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/16/1119 20160726; UK PLGB 53092/0082 20160726 |
2310095 | C02310095/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: GRAZOPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65861 01.04.2016 |
2410844 | 2017006 | Norway | ⤷ Sign Up | PRODUCT NAME: ELBASVIR ELLER ET FARMASOEYTISK; REG. NO/DATE: EU/1/16/1119 20160804 |
2410844 | 680 | Finland | ⤷ Sign Up | |
2310095 | 2017004 | Norway | ⤷ Sign Up | PRODUCT NAME: GRAZOPREVIR ELLER ET; REG. NO/DATE: EU/1/16/1119 20160804 |
2410844 | CA 2016 00069 | Denmark | ⤷ Sign Up | PRODUCT NAME: ELBASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1119 20160726 |
2310095 | 681 | Finland | ⤷ Sign Up | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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