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Generated: June 25, 2017
What is the patent landscape for Farxiga, and when can generic versions of Farxiga launch?
Farxiga is a drug marketed by Astrazeneca Ab and is included in one NDA. There are eleven patents protecting this drug.| Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 2 |
| Bulk Api Vendors: see list | 67 |
| Clinical Trials: see list | 20 |
| Drug Prices: | see details |
| DailyMed Link: | FARXIGA at DailyMed |
| Drug Class | Sodium-Glucose Cotransporter 2 Inhibitor |
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca Ab | FARXIGA | dapagliflozin propanediol | TABLET;ORAL | 202293-001 | Jan 8, 2014 | RX | Yes | No | 7,919,598 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Astrazeneca Ab | FARXIGA | dapagliflozin propanediol | TABLET;ORAL | 202293-002 | Jan 8, 2014 | RX | Yes | Yes | 9,198,925 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Astrazeneca Ab | FARXIGA | dapagliflozin propanediol | TABLET;ORAL | 202293-002 | Jan 8, 2014 | RX | Yes | Yes | 8,501,698 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Astrazeneca Ab | FARXIGA | dapagliflozin propanediol | TABLET;ORAL | 202293-001 | Jan 8, 2014 | RX | Yes | No | 8,361,972 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Astrazeneca Ab | FARXIGA | dapagliflozin propanediol | TABLET;ORAL | 202293-001 | Jan 8, 2014 | RX | Yes | No | 8,716,251 | ► Subscribe | Y | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,453,039 | Crystal structures of SGLT2 inhibitors and processes for preparing same | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2016104753 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 536605 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 4365554 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 20085169 | ► Subscribe | |||||||||||||||||||||||||||
| Croatia | P20041084 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014000070 | Germany | ► Subscribe | PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116 | ||||||||||||||||||||||||||
| 496 | Luxembourg | ► Subscribe | PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1 | ||||||||||||||||||||||||||
| 2014026,C1506211 | Lithuania | ► Subscribe | PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 | ||||||||||||||||||||||||||
| 90017-0 | Sweden | ► Subscribe | PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112 | ||||||||||||||||||||||||||
| 6 5005-2013 | Slovakia | ► Subscribe | PRODUCT NAME: DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112 | ||||||||||||||||||||||||||
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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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