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.
The generic ingredient in CHANTIX is varenicline tartrate. There are twelve drug master file entries for this compound. Twenty-four 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 ENDO OPERATIONS on August 11th, 2021.
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Questions you can ask:
- What is the 5 year forecast for CHANTIX?
- What are the global sales for CHANTIX?
- What is Average Wholesale Price for CHANTIX?
Summary for CHANTIX
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 98 |
Clinical Trials: | 167 |
Patent Applications: | 132 |
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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pf Prism Cv | CHANTIX | varenicline tartrate | TABLET;ORAL | 021928-002 | May 10, 2006 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 |
---|---|---|---|
Norway | 2006016 | ⤷ Sign Up | |
European Patent Office | 1619192 | COMPOSES AZAPOLYCYCLIQUES A FUSION ARYLE (ARYL FUSED AZAPOLYCYCLIC COMPOUNDS) | ⤷ Sign Up |
Spain | 2246396 | ⤷ Sign Up | |
Norway | 20024042 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CHANTIX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1044189 | PA2008010 | Lithuania | ⤷ Sign Up | PRODUCT NAME: VARENICLINUM TARTRAT; REG. NO/DATE: EU/1/06/360/001-010 20060926 |
1044189 | 08C0039 | France | ⤷ Sign Up | 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 | SPC/GB08/034 | United Kingdom | ⤷ Sign Up | 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 |
1044189 | C01044189/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: VARENICLIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57736 21.12.2006 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |