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CHANTIX Drug Profile
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» See Plans and PricingWhen 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 three patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and eighty-three patent family members in fifty-seven countries.
The generic ingredient in CHANTIX is varenicline tartrate. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.
US ANDA Litigation and Generic Entry Outlook for Chantix
Chantix was eligible for patent challenges on May 10, 2010.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 3, 2023. This may change due to patent challenges or generic licensing.
Annual sales in 2017 were $264mm indicating the motivation for generic entry (peak sales were $304mm in 2016).
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
There is one tentative approval for the generic drug (varenicline tartrate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for CHANTIX
| International Patents: | 183 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 71 |
| Clinical Trials: | 79 |
| Patent Applications: | 4 |
| 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 |
| DailyMed Link: | CHANTIX at DailyMed |
Generic Entry Opportunity Date for CHANTIX
Generic Entry Date for CHANTIX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for CHANTIX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institutes of Health (NIH) | Phase 4 |
| Medical University of South Carolina | Phase 4 |
| National Cancer Institute (NCI) | Phase 4 |
Pharmacology for CHANTIX
| Drug Class | Partial Cholinergic Nicotinic Agonist |
| Mechanism of Action | Partial Cholinergic Nicotinic Agonists |
Synonyms for CHANTIX
| (2S,3S)-2,3-dihydroxybutanedioic acid; 5,8,14-triazatetracyclo[10.3.1.0^{2,11}.0^{4,9}]hexadeca-2(11),3,5,7,9-pentaene |
| (6R,10S)-7,8,9,10-tetrahydro-6H-6,10-methanoazepino[4,5-g]quinoxaline (2R,3R)-2,3-dihydroxysuccinate |
| 375815-87-5 |
| 5,8,14-triazatetracyclo[10.3.1.02,11.04,9]-hexadeca-2(11),3,5,7,9-pentaene L-tartrate |
| 6,10-Methano-6H-pyrazino(2,3-h)(3)benzazepine, 7,8,9,10-tetrahydro-, (2R,3R)-2,3-dihydroxybutanedioate (1:1) |
| 7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino(2,3-h)(3)benzazepine (2R,3R)-2,3-dihydroxybutanedioate |
| 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino(2,3-h)(3)benzazepine tartrate |
| 7,8,9,10-Tetrahydro-6H-6,10-methanoazepino-[4,5-g]quinoxaline (2R,3R)-2,3-dihydroxysuccinate |
| 7,8,9,10-tetrahydro-6H-6,10-methanoazepino[4,5-g]quinoxalin-8-ium (2R,3R)-3-carboxy-2,3-dihydroxypropanoate |
| 7,8,9,10-tetrahydro-6H-6,10-methanoazepino[4,5-g]quinoxaline (2R,3R)-2,3-dihydroxysuccinate |
| 7,8,9,10-tetrahydro-6H-6,10-methanoazepino[4,5-g]quinoxaline (2R,3R)-2,3-dihydroxysuccinic acid |
| 7,8,9,10-tetrahydro-6H-6,10-methanoazepino[4,5-g]quinoxaline (2S,3S)-2,3-dihydroxysuccinate |
| 815V875 |
| 82269ASB48 |
| A21286 |
| AB2000110 |
| AKOS005146509 |
| AKOS025311300 |
| AKOS026750167 |
| AOB5603 |
| API0006308 |
| AS-35136 |
| C13H13N3.C4H6O6 |
| CAS-375815-87-5 |
| CCG-221351 |
| Champix |
| Champix (TN) |
| Champix tartrate |
| Chantix (TN) |
| Chantix tartrate |
| Chantix;Champix |
| CHEBI:84507 |
| CHEMBL1201135 |
| CP 526555-18 |
| CP-526,555-18 |
| CP-526555-18 |
| CS-0830 |
| D06282 |
| DSSTox_CID_28998 |
| DSSTox_GSID_49072 |
| DSSTox_RID_83263 |
| DTXSID0049072 |
| FT-0675785 |
| HMS3260I15 |
| HY-10021 |
| LS-186594 |
| NCGC00260732-01 |
| PubChem18805 |
| PubChem18821 |
| Q-101415 |
| Q27157813 |
| Q47485750 |
| s1440 |
| SB17431 |
| SC-24629 |
| SCHEMBL224852 |
| Tox21_113630 |
| Tox21_500047 |
| TWYFGYXQSYOKLK-LREBCSMRSA-N |
| UNII-82269ASB48 |
| Varenicline (Tartrate) |
| varenicline monotartrate |
| Varenicline tartrate |
| Varenicline tartrate (JAN/USAN) |
| Varenicline tartrate [USAN] |
| Varenicline tartrate solution, 500 mug/mL in methanol (as free base), ampule of 1 mL, certified reference material |
| Varenicline tartrate, >=98% (HPLC) |
| Varenicline-tartrate |
| X1052 |
| X4690 |
| Z1642292115 |
Paragraph IV (Patent) Challenges for CHANTIX
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CHANTIX | TABLET;ORAL | varenicline tartrate | 021928 | 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 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Pf Prism Cv | CHANTIX | varenicline tartrate | TABLET;ORAL | 021928-001 | May 10, 2006 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pf Prism Cv | CHANTIX | varenicline tartrate | TABLET;ORAL | 021928-001 | May 10, 2006 | RX | Yes | No | Start Trial | Start Trial | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Croatia | P20020700 | Start Trial |
| Spain | 2301210 | Start Trial |
| Iceland | 2293 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CHANTIX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1044189 | C01044189/01 | Switzerland | Start Trial | PRODUCT NAME: VARENICLIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57736 21.12.2006 |
| 1044189 | 300355 | Netherlands | Start Trial | 300355, 20181113, EXPIRES: 20220425 |
| 1044189 | 91442 | Luxembourg | Start Trial | 91442, EXPIRES: 20210926 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
