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CHANTIX Drug Profile
Which patents cover Chantix, 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.
Summary for CHANTIX
| International Patents: | 183 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 70 |
| Clinical Trials: | 71 |
| 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 |
|---|---|
| Medical University of South Carolina | Phase 2 |
| Oyster Point Pharma, Inc. | Phase 1 |
| University of Kansas Medical Center | Phase 3 |
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 |
| 7,8,9,10-tetrahydro-6h-6,10-methanoazepino[4,5-g]quinoxaline 2,3-dihydroxybutanedioate(1:1) |
| 815V875 |
| 82269ASB48 |
| A21286 |
| AB2000110 |
| AC1L55H3 |
| AC1Q5QUE |
| AKOS005146509 |
| AKOS025311300 |
| AKOS026750167 |
| AN-6400 |
| AOB5603 |
| API0006308 |
| AS-35136 |
| BC630727 |
| C13H13N3.C4H6O6 |
| CAS-375815-87-5 |
| CCG-221351 |
| Champix |
| Champix tartrate |
| Chantix tartrate |
| Chantix; Champix; CP 526555-18 |
| 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 |
| I14-8434 |
| LS-186594 |
| MolPort-009-682-971 |
| MolPort-023-220-723 |
| NCGC00260732-01 |
| PubChem18805 |
| PubChem18821 |
| Q-101415 |
| 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 1.0 mg/ml in Methanol (as free base) |
| Varenicline tartrate solution, 500 mug/mL in methanol (as free base), ampule of 1 mL, certified reference material |
| Varenicline tartrate, >=98% (HPLC) |
| Varenicline Tartrate|375815-87-5|Champix tartrate|Chantix tartrate |
| X1052 |
| X4690 |
| Z1642292115 |
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 | 021928-002 | May 10, 2006 | RX | Yes | Yes | 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 | ||||
| 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 |
Paragraph IV (Patent) Challenges for CHANTIX
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 0.5 mg and 1 mg | ➤ Subscribe | Start Trial |
International Patents for CHANTIX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Panama | 8463901 | Start Trial |
| Bulgaria | 106908 | Start Trial |
| Mexico | PA02008311 | Start Trial |
| Slovakia | 13362003 | 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 | 325 | Finland | Start Trial | |
| 1044189 | PA2008010 | Lithuania | Start Trial | PRODUCT NAME: VARENICLINUM TARTRAT; REG. NO/DATE: EU/1/06/360/001-010 20060926 |
| 1044189 | 300355 | Netherlands | Start Trial | 300355, 20181113, EXPIRES: 20220425 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
