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Generated: June 27, 2017
Which patents cover Daklinza, and what generic Daklinza 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.| Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 10 |
| Clinical Trials: see list | 8 |
| Drug Prices: | see details |
| DailyMed Link: | DAKLINZA at DailyMed |
| 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 | RX | Yes | No | 8,329,159 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Bristol-myers Squibb | DAKLINZA | daclatasvir dihydrochloride | TABLET;ORAL | 206843-002 | Jul 24, 2015 | RX | Yes | Yes | 8,642,025 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Bristol-myers Squibb | DAKLINZA | daclatasvir dihydrochloride | TABLET;ORAL | 206843-001 | Jul 24, 2015 | RX | Yes | No | 8,642,025 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Bristol-myers Squibb | DAKLINZA | daclatasvir dihydrochloride | TABLET;ORAL | 206843-001 | Jul 24, 2015 | RX | Yes | No | 8,629,171 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Bristol-myers Squibb | DAKLINZA | daclatasvir dihydrochloride | TABLET;ORAL | 206843-002 | Jul 24, 2015 | RX | Yes | Yes | 8,900,566 | ► Subscribe | ► Subscribe | ||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,227,961 | Hepatitis C virus inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 8,303,944 | Hepatitis C virus inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 8,846,023 | Hepatitis C virus inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 8,574,563 | Hepatitis C virus inhibitors | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 2007286222 | ► Subscribe | |||||||||||||||||||||||||||
| Mexico | 2010001368 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | 200911790 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2402791 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 101450352 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2015 00003 | Denmark | ► Subscribe | PRODUCT NAME: DACLATASVIR OG FARMACEUTISK ACCEPTABLE SALTE DERAF, SAERLIGT DACLATASVIR-DIHYDROCHLORID; REG. NO/DATE: EU/1/14/939 20140822 | ||||||||||||||||||||||||||
| 2015006,C2049522 | Lithuania | ► Subscribe | 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, 0140822 | ||||||||||||||||||||||||||
| 635 | Luxembourg | ► Subscribe | PRODUCT NAME: DACLATASVIR ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES , EN PARTICULIER DICHLORHYDRATE DE DACLATASVIR. FIRST REGISTRATION: 20140826 | ||||||||||||||||||||||||||
| 0713 | Netherlands | ► Subscribe | PRODUCT NAME: DACLATASVIR EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN, IN HET BIJZONDER DACLATASVIR DIHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/939/001-004 20140826 | ||||||||||||||||||||||||||
| 2015 | Austria | ► Subscribe | PRODUCT NAME: DECLATASVIR; REGISTRATION NO/DATE: EU/1/14/939 (MITTEILUNG) 20140826 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
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