CHANTIX Drug Patent Profile
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When do Chantix patents expire, and what generic alternatives are available?
Chantix is a drug marketed by Pf Prism Cv and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-one patent family members in forty-eight countries.
The generic ingredient in CHANTIX is varenicline tartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Chantix
A generic version of CHANTIX was approved as varenicline tartrate by PAR PHARM INC on August 11th, 2021.
Summary for CHANTIX
| International Patents: | 61 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 94 |
| Clinical Trials: | 166 |
| Patent Applications: | 208 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CHANTIX |
| Drug Sales Revenues: | Drug sales revenues for CHANTIX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CHANTIX |
| What excipients (inactive ingredients) are in CHANTIX? | CHANTIX excipients list |
| DailyMed Link: | CHANTIX at DailyMed |
Recent Clinical Trials for CHANTIX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Massachusetts General Hospital | Phase 3 |
| Mayo Clinic | Early Phase 1 |
| Duke University | Phase 4 |
Pharmacology for CHANTIX
| Drug Class | Partial Cholinergic Nicotinic Agonist |
| Mechanism of Action | Partial Cholinergic Nicotinic Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for CHANTIX
Paragraph IV (Patent) Challenges for CHANTIX
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| CHANTIX | Tablets | varenicline tartrate | 0.5 mg and 1 mg | 021928 | 5 | 2010-05-10 |
US Patents and Regulatory Information for CHANTIX
CHANTIX is protected by two US patents and two FDA Regulatory Exclusivities.
Patents protecting CHANTIX
Tartrate salts of 5,8, 14-triazateracyclo[10.3.1.02,11 04.9]-hexadeca-2(11),3,5,7,9-pentaene and pharmaceutical compositions thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tartrate salts of 5,8,14-triazatetracyclo[10.3.1.0.sup.2,11.0.sup.4.9]-hexadeca-2(11),3,5,7- ,9-pentaene and pharmaceutical compositions thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting CHANTIX
INFORMATION ADDED TO LABELING TO DESCRIBE A STUDY TO EVALUATE THE SAFETY AND EFFICACY OF VARENICLINE FOR SMOKING CESSATION IN ADOLESCENT SMOKERS
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pf Prism Cv | CHANTIX | varenicline tartrate | TABLET;ORAL | 021928-001 | May 10, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Pf Prism Cv | CHANTIX | varenicline tartrate | TABLET;ORAL | 021928-002 | May 10, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pf Prism Cv | CHANTIX | varenicline tartrate | TABLET;ORAL | 021928-001 | May 10, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pf Prism Cv | CHANTIX | varenicline tartrate | TABLET;ORAL | 021928-002 | May 10, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pf Prism Cv | CHANTIX | varenicline tartrate | TABLET;ORAL | 021928-001 | May 10, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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 CHANTIX
See the table below for patents covering CHANTIX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 122008000038 | ⤷ Try a Trial | |
| Poland | 366551 | ⤷ Try a Trial | |
| European Patent Office | 1259489 | COMPOSES AZAPOLYCYCLIQUES A FUSION ARYLE (ARYL FUSED AZAPOLYCYCLIC COMPOUNDS) | ⤷ Try a Trial |
| Slovenia | 1044189 | ⤷ Try a Trial | |
| Spain | 2246396 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CHANTIX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1044189 | SPC021/2008 | Ireland | ⤷ Try a Trial | SPC021/2008: 20081105, EXPIRES: 20210925 |
| 1044189 | CA 2008 00031 | Denmark | ⤷ Try a Trial | |
| 1044189 | 122008000038 | Germany | ⤷ Try a Trial | PRODUCT NAME: VARENICLIN GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES UNTER EINSCHLUSS VON TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001-010 20060926 |
| 1044189 | 08C0039 | France | ⤷ Try a Trial | 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 |
| 1044189 | 91442 | Luxembourg | ⤷ Try a Trial | 91442, EXPIRES: 20210926 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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