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
International Patents for daclatasvir dihydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2476592 | ⤷ Sign Up | |
Croatia | P20160410 | ⤷ Sign Up | |
China | 101558059 | Hepatitis c virus inhibitors | ⤷ Sign Up |
Hungary | E037802 | ⤷ Sign Up | |
Japan | 5244179 | ⤷ Sign Up | |
Cyprus | 1117641 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for daclatasvir dihydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2049522 | 9/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826 |
2049522 | PA2015006,C2049522 | Lithuania | ⤷ Sign Up | 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 | SPC/GB15/003 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REGISTERED: UK EU/1/14/939/001-004 20140826 |
2049522 | PA2015006 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DACLATASVIRUM; REGISTRATION NO/DATE: EU/1/14/939/001 - EU/1/14/939/004 20140826 |
2049522 | 2015C/006 | Belgium | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE |
2049522 | 122015000009 | Germany | ⤷ Sign Up | 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 |