DACLATASVIR DIHYDROCHLORIDE - Generic Drug Details
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What are the generic sources for daclatasvir dihydrochloride and what is the scope of patent protection?
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 |
University of Oxford | N/A |
US Patents and Regulatory Information for DACLATASVIR DIHYDROCHLORIDE
International Patents for DACLATASVIR DIHYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Slovenia | 2049522 | ⤷ Try a Trial | |
Japan | 2013151535 | HEPATITIS C VIRUS INHIBITORS | ⤷ Try a Trial |
Mexico | 2010001368 | FORMA CRISTALINA DE LA SAL DICLORHIDRATO DE ((1S)-1-(((2S)-2-(5-(4 ́-(2-((2S)-1-((2S)-2-((METOXICARBONIL) AMINO)-3-METILBUTANOIL)-2-P IRROLIDINIL)-1H-IMIDAZOL-5-IL)-4-BIFENILIL)-1H-IMIDAZOL-2-IL)-1-P IRROLIDINIL) CARBONIL)-2-METILPROPIL)CARBAMATO DE (CRYSTALLINE FORM OF METHYL ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2 S)-2-((METHOXYCARBONYL)AMINO)-3-METHYLBUTANOYL)-2-PYRROLIDINYL)- 1H-IMIDAZOL-5-YL)-4-BIPHENYLYL)-1H-IMIDAZOL-2-YL)-1-PYRROLIDINYL )CARBONYL)-2-METHYLPROPYL)CARBAMATE DIHYDROCHLORIDE SA) | ⤷ Try a Trial |
South Africa | 200900962 | HEPATITIS C VIRUS INHIBITORS | ⤷ Try a Trial |
Norway | 340543 | ⤷ Try a Trial | |
Hong Kong | 1144089 | 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 |
Taiwan | I359813 | ⤷ 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 | 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 |
2049522 | CR 2015 00003 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140826 |
2049522 | 15C0007 | France | ⤷ Try a Trial | PRODUCT NAME: DACLATASVIR ET DES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI,EN PARTICULIER LE SEL DE DICHLORHYDRATE DE DACLATASVIR; REGISTRATION NO/DATE: EU/1/14/939/001 20140826 |
2049522 | PA2015006 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DACLATASVIRUM; REGISTRATION NO/DATE: EU/1/14/939/001 - EU/1/14/939/004 20140826 |
2049522 | 524 | Finland | ⤷ Try a Trial | |
2049522 | 9/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826 |
2049522 | 122015000009 | Germany | ⤷ Try a Trial | PRODUCT NAME: DACLATASVIR UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE DACLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939/001-004 20140822 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |