DAKLINZA Drug Patent Profile
✉ Email this page to a colleague
When do Daklinza patents expire, and when can generic versions of Daklinza launch?
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 ninety-three 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. Additional details are available on the daclatasvir dihydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Daklinza
Daklinza was eligible for patent challenges on July 24, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 13, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for DAKLINZA?
- What are the global sales for DAKLINZA?
- What is Average Wholesale Price for DAKLINZA?
Summary for DAKLINZA
| International Patents: | 93 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 128 |
| Clinical Trials: | 13 |
| Patent Applications: | 13 |
| Drug Prices: | Drug price information for DAKLINZA |
| DailyMed Link: | DAKLINZA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DAKLINZA
*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 |
|---|---|
| Ain Shams University | Phase 3 |
| Cairo University | Phase 3 |
| Tanta University | Phase 2/Phase 3 |
US Patents and Regulatory Information for DAKLINZA
DAKLINZA is protected by eight US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of DAKLINZA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting DAKLINZA
Hepatitis C virus inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Crystalline form of methyl ((1S)-1-((25)-2-(5-(4'-(2-((25)-1((2S)-2-((methoxycarbonyl)amino)-3-methy- lbutanoyl)-2-pyrrolidinyl)-1H-imidazol-2-yl)-1-pyrrolidinyl)carbonyl)-2-me- thylpropyl)carbamate dihydrochloride salt
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS
Hepatitis C virus inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS
Hepatitis C virus inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
Hepatitis C virus inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
Hepatitis C virus inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS
Hepatitis C virus inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
Hepatitis C virus inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF INHIBITING HEPATITIS C VIRUS
| 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 | ⤷ 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 | 206843-002 | Jul 24, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | 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 DAKLINZA
When does loss-of-exclusivity occur for DAKLINZA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 0016
Patent: FORMA CRISTALINA DE LA SAL DICLORHIDRATO DE ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2S)-2-((METOXICARBONIL)AMINO)-3-METILBUTANO IL)-2-PIRROLIDINIL)-1H-IMIDAZOL-5-IL)-4-BIFENILIL)-1H-IMIDAZOL-2-IL)-1-PIRROLIDINIL)CARBONIL)-2-METILPROPIL)CARBAMATO DE METILO
Estimated Expiration: ⤷ Sign Up
Patent: 4566
Patent: FORMA CRISTALINA DE LA SAL DICLORHIDRATO DE ((1S)-1-(((2S)-2-(5-(4-(2-((2S)-1-((2S)-2-((METOXICARBONIL)AMINO)-3-METILBUTANOIL)-2-PIRROLIDINIL)-1H-IMIDAZOL-5-IL)-4-BIFENILIL)-1H-IMIDAZOL-2-IL)-1-PIRROLIDINIL)CARBONIL)-2-METILPROPIL)CARBAMATO DE METILO
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 08284100
Patent: 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
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0815142
Patent: FORMA CRISTALINA DO SAL DE DICLORIDRATO ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2S)-2-((METOXICARBONIL)-3-MET ILBUTANOIL)-2-PIRROLIDINIL)-1H-IMIDAZOL-5-IL)-4-BIFENILIL)- 1H-IMIDAZOL-2-IL)-1-PIRROLIDINIL)CARBONIL)-2-METELPROPI L)CARBAMATO DE METILA
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 95729
Patent: FORME CRISTALLINE DE DIHYDROCHLORURE DE 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 (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)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 08002354
Patent: Forma cristalina de la sal diclorhidrato de ((1s)-1-(((2s)-2-(5-(4'-(2-((2s)-1-((2s)-2-((metoxicarbonil)amino)-3-metilbutanoil)-2-pirrolidinil)-1h-imidazol-5-il)-4-bifenilil)-1h-imidazol-2-il)-1-pirrolidinil)carbonil)-2-metilpropil)carbamato de metilo; composición y combinacion farmacéutica; y su uso para tratar la hepatitis c.
Estimated Expiration: ⤷ Sign Up
China
Patent: 1778840
Patent: 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
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 60327
Patent: FORMA CRISTALINA DE LA SAL DICLORHIDRATO DE ((2S)-2-(5-(4`-(2((2S)-1-((2S)-2-((METOXICARBONIL)AMINO)-3-METILBUTANIOL)-2-PIRROLIDINIL)-1H-IMIDAZOL-5-IL-4BIFENILIL)-1H-IMIDAZOL-2-IL)-1-PIRROLIDINIL)CARBONIL)-2-METILPROPIL)CARBAMATO DE METILO
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 8152
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА ДИГИДРОХЛОРИДА МЕТИЛ ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2S)-2-((МЕТОКСИКАРБОНИЛ)АМИНО)-3-МЕТИЛБУТАНОИЛ)-2-ПИРРОЛИДИНИЛ)-1Н-ИМИДАЗОЛ-5-ИЛ)-4-БИФЕНИЛИЛ)-1Н-ИМИДАЗОЛ-2-ИЛ)-1-ПИРРОЛИДИНИЛ)КАРБОНИЛ)-2-МЕТИЛПРОПИЛ)КАРБАМАТА (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)
Estimated Expiration: ⤷ Sign Up
Patent: 1000196
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА ДИГИДРОХЛОРИДА МЕТИЛ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2S)-2-((МЕТОКСИКАРБОНИЛ)АМИНО)-3-МЕТИЛБУТАНОИЛ)-2-ПИРРОЛИДИНИЛ)-1Н-ИМИДАЗОЛ-5-ИЛ)-4-БИФЕНИЛИЛ)-1Н-ИМИДАЗОЛ-2-ИЛ)-1-ПИРРОЛИДИНИЛ)КАРБОНИЛ)-2-МЕТИЛПРОПИЛ)КАРБАМАТА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 83244
Patent: FORME CRISTALLINE DE DIHYDROCHLORURE DE MÉTHYL ((1S)-1-(((2S>2-(5-(4'-(2-((2S)-1-((2S)-2-((MÉTHOXYCARBONYL)AMINO)-3-MÉTHYLBUTANOYL)-2-PYRROLIDINYL)-1H-IMIDAZOL-5-YL)-4-BIPHÉNYLYL)-1H-IMIDAZOL-2-YL)-1-PYRROLIDINYL)CARBONYL)-2-MÉTHYLPROPYL)CARBAMATE (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)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 44089
Patent: 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
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 3684
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 44179
Estimated Expiration: ⤷ Sign Up
Patent: 10535785
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 10001368
Patent: 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)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 3148
Patent: 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
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 090940
Patent: FORMA CRISTALINA DE LA SAL DICLORHIDRATO DE ((1S)-1-(((2S)-2-(5-(4'-(2-((2S)-1-((2S)-2-((METOXICARBONIL)AMINO)-3-METILBUTANOIL)-2-PIRROLIDINIL)-1H-IMIDAZOL-5-IL)-4-BIFENILIL)-1H-IMIDAZOL-2-IL)-1-PIRROLIDINIL)CARBONIL)-2-METILPROPIL)CARBAMATO DE METIL
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1000843
Patent: 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
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1508022
Estimated Expiration: ⤷ Sign Up
Patent: 100042641
Patent: 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
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 02791
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 59813
Estimated Expiration: ⤷ Sign Up
Patent: 0911790
Patent: 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
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering DAKLINZA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 2009001426 | INHIBIDORES DEL VIRUS DE LA HEPATITIS C. (HEPATITIS C VIRUS INHIBITORS.) | ⤷ Sign Up |
| Chile | 2007002327 | COMPUESTOS DERIVADOS DE FENIL-IMIDAZOL SUSTITUIDO; COMPOSICION FARMACEUTICA; Y USO EN EL TRATAMIENTO DEL VHC. | ⤷ Sign Up |
| Slovenia | 3042901 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DAKLINZA
| 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 | 9/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
