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
*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 |
| Queen Mary University of London | 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 | 206843-002 | Jul 24, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | ||
| >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 |
|---|---|---|---|
| Chile | 2007002327 | COMPUESTOS DERIVADOS DE FENIL-IMIDAZOL SUSTITUIDO; COMPOSICION FARMACEUTICA; Y USO EN EL TRATAMIENTO DEL VHC. | ⤷ Sign Up |
| Taiwan | 200813029 | Hepatitis C virus inhibitors | ⤷ Sign Up |
| Croatia | P20180496 | ⤷ 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 | 211 50001-2015 | Slovakia | ⤷ Sign Up | PRODUCT NAME: DAKLATASVIR DIHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/939 - EU/1/14/939/004 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
