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DAKLINZA Drug Profile
Which patents cover Daklinza, and what generic alternatives are available?
Daklinza is a drug marketed by Bristol-myers Squibb and is included in one NDA. There are five patents protecting this drug.
This drug has eighty-nine patent family members in thirty-one countries.
The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the daclatasvir dihydrochloride profile page.
Summary for DAKLINZA
| International Patents: | 89 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 85 |
| Clinical Trials: | 11 |
| Patent Applications: | 103 |
| Drug Prices: | Drug price information for DAKLINZA |
| DailyMed Link: | DAKLINZA at DailyMed |
Generic Entry Opportunity Date for DAKLINZA
Generic Entry Date for DAKLINZA*:
Constraining patent/regulatory exclusivity:
NDA:
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 DAKLINZA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Nanjing Sanhome Pharmaceutical, Co., Ltd. | Phase 2/Phase 3 |
| Johns Hopkins Bloomberg School of Public Health | Phase 2/Phase 3 |
| National Institute on Drug Abuse (NIDA) | Phase 2/Phase 3 |
Pharmacology for DAKLINZA
Synonyms for DAKLINZA
| 1009119-65-6 |
| 50ZO25C11D |
| AC-28423 |
| AK546321 |
| AKOS030632774 |
| AOB87340 |
| BMS 790052 |
| BMS 790052 (di HClsalt) |
| BMS 790052-05 |
| BMS-790052 |
| BMS-790052 (dihydrochloride) |
| BMS-790052 dihydrochloride |
| BMS-790052-05 |
| BMS790052 dihydrochloride |
| CHEBI:83800 |
| CHEMBL2303621 |
| CS-0270 |
| D10105 |
| Daclatasvir (dihydrochloride) |
| Daclatasvir dihydrochloride |
| Daclatasvir dihydrochloride (BMS-790052) |
| Daclatasvir dihydrochloride (USAN) |
| daclatasvir hydrochloride |
| Daclatasvir hydrochloride (JAN) |
| Daklinza (TN) |
| dimethyl ((2S,2'S)-((2S,2'S)-2,2'-(5,5'-([1,1'-biphenyl]-4,4'-diyl)bis(1H-imidazole-5,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl))dicarbamate dihydrochloride |
| Dimethyl N,N'-(biphenyl-4,4'-diylbis(1H-imidazole-5,2-diyl-((2S)-pyrrolidine-2,1- diyl)((1S)-1-(1-methylethyl)-2-oxoethane-2,1-diyl)))dicarbamate dihydrochloride |
| HY-10465 |
| KS-00000P35 |
| methyl [(2S)-1-{(2S)-2-[4-(4'-{2-[(2S)-1-{(2S)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}pyrrolidin-2-yl]-1H-imidazol-4-yl}biphenyl-4-yl)-1H-imidazol-2-yl]pyrrolidin-1-yl}-3-methyl-1-oxobutan-2-yl]carbamate dihydrochloride |
| MolPort-042-665-812 |
| SCHEMBL17870647 |
| UNII-50ZO25C11D |
| W-6070 |
US Patents and Regulatory Information for DAKLINZA
| 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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Bristol-myers Squibb | DAKLINZA | daclatasvir dihydrochloride | TABLET;ORAL | 206843-002 | Jul 24, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Bristol-myers Squibb | DAKLINZA | daclatasvir dihydrochloride | TABLET;ORAL | 206843-002 | Jul 24, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Bristol-myers Squibb | DAKLINZA | daclatasvir dihydrochloride | TABLET;ORAL | 206843-001 | Jul 24, 2015 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start 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 DAKLINZA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1201535 | Start Trial |
| Eurasian Patent Organization | 200900298 | Start Trial |
| Colombia | 6160327 | Start Trial |
| European Patent Office | 2385048 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DAKLINZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2049522 | 1590007-9 | Sweden | Start Trial | PRODUCT NAME: DACLATASVIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY DACLATASVIR DIHYDROCHLORIDE; REG. NO/DATE: EU/1/14/939 20140826 |
| 2049522 | C20150003 00128 | Estonia | Start Trial | PRODUCT NAME: DAKLATASVIIR;REG NO/DATE: EU/1/14/939 26.08.2014 |
| 2049522 | 9/2015 | Austria | Start Trial | PRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826 |
| 2049522 | 300713 | Netherlands | Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
