Daclatasvir dihydrochloride - Generic Drug Details
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What are the generic sources for daclatasvir dihydrochloride and what is the scope of freedom to operate?
Daclatasvir dihydrochloride
is the generic ingredient in one branded drug marketed by Bristol-myers Squibb and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Daclatasvir dihydrochloride has ninety-three patent family members in thirty-one countries.
There are five drug master file entries for daclatasvir dihydrochloride.
Summary for daclatasvir dihydrochloride
International Patents: | 93 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 135 |
Clinical Trials: | 127 |
Patent Applications: | 1,327 |
DailyMed Link: | daclatasvir dihydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for daclatasvir dihydrochloride
Generic Entry Date for daclatasvir dihydrochloride*:
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 daclatasvir dihydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Tanta University | Phase 3 |
Ain Shams University | Phase 3 |
Aga Khan University | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for daclatasvir dihydrochloride
US Patents and Regulatory Information for daclatasvir dihydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bristol-myers Squibb | DAKLINZA | daclatasvir dihydrochloride | TABLET;ORAL | 206843-001 | Jul 24, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Bristol-myers Squibb | DAKLINZA | daclatasvir dihydrochloride | TABLET;ORAL | 206843-002 | Jul 24, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bristol-myers Squibb | DAKLINZA | daclatasvir dihydrochloride | TABLET;ORAL | 206843-002 | 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 |
International Patents for daclatasvir dihydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2695729 | FORME CRISTALLINE DE DIHYDROCHLORURE DE METHYL ((1S)-1-(((2S>2-(5-(4'-(2-((2S)-1-((2S)-2-((METHOXYCARBONYL)AMINO)-3-METHYLBUTANOYL)-2-PYRROLIDINYL)-1H-IMIDAZOL-5-YL)-4-BIPHENYLYL)-1H-IMIDAZOL-2-YL)-1-PYRROLIDINYL)CARBONYL)-2-METHYLPROPYL)CARBAMATE (CRYSTALLINE FORM OF METHYL ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2S)-2-((METHOXYCARBONYL)AMINO)-3-METHYLBUTANOYL)-2-PYRROLIDINYL)-1H-IMIDAZOL-5-YL)-4-BIPHENYLYL)-1H-IMIDAZOL-2-YL)-1-PYRROLIDINYL)CARBONYL)-2-METHYLPROPYL)CARBAMATE DIHYDROCHLORIDE SALT) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2009020828 | ⤷ Try a Trial | |
Mexico | 2009001426 | INHIBIDORES DEL VIRUS DE LA HEPATITIS C. (HEPATITIS C VIRUS INHIBITORS.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for daclatasvir dihydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2049522 | C20150003 00128 | Estonia | ⤷ Try a Trial | PRODUCT NAME: DAKLATASVIIR;REG NO/DATE: EU/1/14/939 26.08.2014 |
2049522 | 211 50001-2015 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: DAKLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939 - EU/1/14/939/004 20140826 |
2049522 | PA2015006,C2049522 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DAKLATASVIRAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, YPAC DAKLATASVIRO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/14/939/001 - EU/1/14/939/004, 2 00140822 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |