CHANTIX Drug Patent Profile
✉ Email this page to a colleague
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.
The generic ingredient in CHANTIX is varenicline tartrate. There are twelve drug master file entries for this compound. Nineteen 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
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 98 |
Clinical Trials: | 166 |
Patent Applications: | 155 |
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 | Cholinergic Receptor Agonist Partial Cholinergic Nicotinic Agonist |
Mechanism of Action | Cholinergic Agonists 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
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 | ⤷ 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 | ||||
>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 |
---|---|---|---|
Iceland | 6459 | ⤷ Try a Trial | |
China | 1715280 | ⤷ Try a Trial | |
New Zealand | 528210 | Tartrate salts of 5,8,14-triazatetracyclo[10.3.1.02,11.04,9]-hexadeca-2(11),3,5,7,9-pentaene and pharmaceutical compositions thereof | ⤷ Try a Trial |
Serbia | 50814 | TARTARATNE SOLI 5,8,14-TRIAZATETRACIKLO(10.3.1.02,11.04,9)- HEKSADEKA-2(11),3,5,7,9-PENTAENA (TARTARATE SALTS OF 5,8,14-TRIAZATETRACYCLO(10.3.1.02,11.04,9 )-HEXADECA-2(11)3,5,7,9-PENTAENE AND PHARMACEUTICAL COMPOSITIONS THEREOF) | ⤷ Try a Trial |
Croatia | P20030910 | TARTARATNE SOLI 5,8,14-TRIAZATETRACIKLO {10.3.1.0<2,11>.0<4,9>}-HEKSADEKA-2(11), 3,5,7,9-PENTAENA I PRIPADAJUĆIH FARMACEUTSKIH SPOJEVA (TARTARATE SALTS 5,8,14-TRIAZATETRACYCLO {10.3.1.02,11.04,9}-HEXADECA-2(11), 3,5,7,9-PENTAENE AND PHARMACEUTICAL COMPOSITIONS THEREOF) | ⤷ Try a Trial |
China | 1263745 | ⤷ 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 | PA2008010,C1044189 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VARENICLINUM TARTRAT; REGISTRATION NO/DATE: EU/1/06/360/001 - EU/1/06/360/010, 0060926 |
1044189 | CA 2008 00031 | Denmark | ⤷ Try a Trial | |
1044189 | 91442 | Luxembourg | ⤷ Try a Trial | 91442, EXPIRES: 20210926 |
1044189 | SPC021/2008 | Ireland | ⤷ Try a Trial | SPC021/2008: 20081105, EXPIRES: 20210925 |
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 | C01044189/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: VARENICLIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57736 21.12.2006 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |