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Serving 500+ biopharmaceutical companies globally:
Generated: August 20, 2017
Which patents cover Chantix, and what generic Chantix alternatives are available?
Chantix is a drug marketed by Pfizer Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.| Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 9 |
| Clinical Trials: see list | 59 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | CHANTIX at DailyMed |
| Drug Class | Partial Cholinergic Nicotinic Agonist |
| Mechanism of Action | Partial Cholinergic Nicotinic Agonists |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer Inc | CHANTIX | varenicline tartrate | TABLET;ORAL | 021928-001 | May 10, 2006 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Pfizer Inc | CHANTIX | varenicline tartrate | TABLET;ORAL | 021928-001 | May 10, 2006 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Pfizer Inc | CHANTIX | varenicline tartrate | TABLET;ORAL | 021928-001 | May 10, 2006 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Pfizer Inc | CHANTIX | varenicline tartrate | TABLET;ORAL | 021928-002 | May 10, 2006 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Pfizer Inc | CHANTIX | varenicline tartrate | TABLET;ORAL | 021928-002 | May 10, 2006 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| varenicline tartrate | Tablets | 0.5 mg and 1 mg | Chantix | 5/10/2010 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,205,300 | Aryl fused azapolycyclic compounds | ► Subscribe | |||||||||||||||||||||||||||
| 6,605,610 | Aryl fused azapolycyclic compounds | ► Subscribe | |||||||||||||||||||||||||||
| 6,897,310 | Aryl fused azapolycyclic compounds | ► Subscribe | |||||||||||||||||||||||||||
| 6,887,884 | Aryl fused azapolycyclic compounds | ► Subscribe | |||||||||||||||||||||||||||
| 6,951,938 | Aryl fused azapolycyclic compounds | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Luxembourg | 91442 | ► Subscribe | |||||||||||||||||||||||||||
| Peru | 00532000 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 20035036 | ► Subscribe | |||||||||||||||||||||||||||
| African Regional IP Organization (ARIPO) | 1860 | ► Subscribe | |||||||||||||||||||||||||||
| Poland | 209404 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5 | Finland | ► Subscribe | |||||||||||||||||||||||||||
| C0039 | France | ► Subscribe | PRODUCT NAME: VARENICLINE OU L?UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, NOTAMMENT LE TARTRATE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/360/001 DU 20060926; REGISTRATION NO/DATE AT EEC: EU/1/06/360/001 DU 20060926 | ||||||||||||||||||||||||||
| 2008000038 | Germany | ► Subscribe | PRODUCT NAME: VARENICLIN GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES UNTER EINSCHLUSS VON TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001-010 20060926 | ||||||||||||||||||||||||||
| 442 | Luxembourg | ► Subscribe | 91442, EXPIRES: 20210926 | ||||||||||||||||||||||||||
| C/GB08/034 | United Kingdom | ► Subscribe | PRODUCT NAME: VARENICLINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE TARTRATE SALT; REGISTRATION NO/DATE: EU/1/06/360/001 - 010 20060928 | ||||||||||||||||||||||||||
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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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