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Serving 500+ biopharmaceutical companies globally:
Generated: August 17, 2017
What is the competitive landscape for EXELIXIS, and when can generic versions of EXELIXIS drugs launch?
EXELIXIS has two approved drugs.| Patents: | 3 |
| Tradenames: | 2 |
| Ingredients: | 1 |
| NDAs: | 2 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-001 | Apr 25, 2016 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-003 | Apr 25, 2016 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Exelixis | COMETRIQ | cabozantinib s-malate | CAPSULE;ORAL | 203756-002 | Nov 29, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-003 | Apr 25, 2016 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-003 | Apr 25, 2016 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2,014,155,378 | ► Subscribe | ||||||||||||||||||||||||||||
| 8,178,532 | c-Met modulators and method of use | ► Subscribe | |||||||||||||||||||||||||||
| 8,067,436 | c-Met modulators and methods of use | ► Subscribe | |||||||||||||||||||||||||||
| 8,476,298 | c-Met modulators and method of use | ► Subscribe | |||||||||||||||||||||||||||
| 9,174,947 | c-Met modulators and methods of use | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taiwan | I511956 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2011042686 | ► Subscribe | |||||||||||||||||||||||||||
| Croatia | P20110707 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 214086 | ► Subscribe | |||||||||||||||||||||||||||
| Slovenia | 2392565 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014 00039 | Denmark | ► Subscribe | PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140326 | ||||||||||||||||||||||||||
| C0067 | France | ► Subscribe | PRODUCT NAME: CABOZANTINIB ET TOUTE FORME THERAPEUTIQUEMENT EQUIVALENTE COUVERTE PAR LE BREVET DE BASE,INCLUANT SES SELS PHARMACEUTIQUEMENT EQUIVALENTS.; REGISTRATION NO/DATE: EU/1/13/890 20140326 | ||||||||||||||||||||||||||
| 00678 | Netherlands | ► Subscribe | PRODUCT NAME: CABOZANTINIB EN ELKE THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, WAARONDER FARMACEUTISCH AANVAARDBARE ZOUTEN; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326 | ||||||||||||||||||||||||||
| 2014033 | Lithuania | ► Subscribe | PRODUCT NAME: CABOZANTINIBUM; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321 | ||||||||||||||||||||||||||
| 0140029 00117 | Estonia | ► Subscribe | PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014 | ||||||||||||||||||||||||||
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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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