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
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 | 206843-002 | Jul 24, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Bristol-myers Squibb | DAKLINZA | daclatasvir dihydrochloride | TABLET;ORAL | 206843-001 | Jul 24, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Bristol-myers Squibb | DAKLINZA | daclatasvir dihydrochloride | TABLET;ORAL | 206843-001 | Jul 24, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Bristol-myers Squibb | DAKLINZA | daclatasvir dihydrochloride | TABLET;ORAL | 206843-002 | Jul 24, 2015 | DISCN | Yes | No | ⤷ 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 |
International Patents for DACLATASVIR DIHYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | E037802 | ⤷ Sign Up | |
Chile | 2007002327 | COMPUESTOS DERIVADOS DE FENIL-IMIDAZOL SUSTITUIDO; COMPOSICION FARMACEUTICA; Y USO EN EL TRATAMIENTO DEL VHC. | ⤷ Sign Up |
South Korea | 20100042641 | 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 | ⤷ Sign Up |
Israel | 203684 | צורות גבישייות של מלחי מיטל ((s1) - 1 - (((s2) - 2 - (5 - ('4 (2 - ((s2) - 1 - ((s2) - 2 - ((מטוקסיקרבוניל) אמינו) - 3 - מטילביוטאנויל) - 2 - פירולידיניל) - h1 - אמידאזול - 5 - איל) - 4 - ביפניליל) - h1 - אימידאזול - 2 - איל) - 1 - פירולידיניל) קרבוניל)-2-מטילפרופיל) קרבמט דיהידרוכלור (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) | ⤷ 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 | 2015/002 | Ireland | ⤷ Sign Up | PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REGISTRATION NO/DATE: EU/14/939/001-004 20140826 |
2049522 | 15C0007 | France | ⤷ Sign Up | 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,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 | CR 2015 00003 | Denmark | ⤷ Sign Up | PRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140826 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |