Varenicline Pill — Competitive Intelligence Brief

Varenicline Pill (Varenicline Pill) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nicotinic receptor partial agonist. Area: Addiction/Smoking Cessation.

marketed Nicotinic receptor partial agonist Alpha-4 beta-2 nicotinic acetylcholine receptor Addiction/Smoking Cessation Small molecule

Target snapshot

Varenicline Pill (Varenicline Pill) — National Institute on Drug Abuse (NIDA). Varenicline is a partial agonist at the alpha-4 beta-2 nicotinic acetylcholine receptor that reduces nicotine cravings and blocks the rewarding effects of nicotine.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Varenicline Pill TARGET	Varenicline Pill	National Institute on Drug Abuse (NIDA)	marketed	Nicotinic receptor partial agonist	Alpha-4 beta-2 nicotinic acetylcholine receptor
Varenicline (VAR)	Varenicline (VAR)	University of Oklahoma	marketed	Nicotinic receptor partial agonist	Alpha-4 beta-2 nicotinic acetylcholine receptor
Varenicline (Champix)	Varenicline (Champix)	University of British Columbia	marketed	Nicotinic receptor partial agonist	Alpha-4 beta-2 nicotinic acetylcholine receptor
Standard Duration Varenicline	Standard Duration Varenicline	University of Wisconsin, Madison	marketed	Nicotinic receptor partial agonist	Alpha-4 beta-2 nicotinic acetylcholine receptor
Varinecline (Chantix)	Varinecline (Chantix)	American University of Beirut Medical Center	marketed	Nicotinic receptor partial agonist	Alpha-4 beta-2 nicotinic acetylcholine receptor
Chantix	Varenicline Tartrate	Pfizer Inc.	marketed	Nicotinic receptor partial agonist	α4β2 neuronal nicotinic acetylcholine receptors
Varenicline Tartarate	Varenicline Tartarate	Pfizer	phase 3	Nicotinic receptor partial agonist	Nicotinic acetylcholine receptors (alpha4beta2 subtype)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

• 2035-10-19 — Chantix · 11224598 · Method of Use · US
• 2035-10-19 — Chantix · 10456396 · Formulation · US
• 2035-10-19 — Chantix · 9597284 · Method of Use · US
• 2035-10-19 — Chantix · 9532944 · Method of Use · US
• 2035-10-19 — Chantix · 9504644 · Method of Use · US
• 2035-10-19 — Chantix · 11911380 · Method of Use · US
• 2035-10-19 — Chantix · 11903943 · Method of Use · US
• 2035-10-19 — Chantix · 11903941 · Method of Use · US
• 2035-10-19 — Chantix · 9504645 · Formulation · US
• 2035-10-19 — Chantix · 11903942 · Formulation · US

Sponsor landscape (Nicotinic receptor partial agonist class)

1. American University of Beirut Medical Center · 1 drug in this class
2. National Institute on Drug Abuse (NIDA) · 1 drug in this class
3. Pfizer · 1 drug in this class
4. Pfizer Inc. · 1 drug in this class
5. University of British Columbia · 1 drug in this class
6. University of Oklahoma · 1 drug in this class
7. University of Wisconsin, Madison · 1 drug in this class