OROS® oxybutynin — Competitive Intelligence Brief

OROS® oxybutynin (OROS® oxybutynin) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Anticholinergic agent. Area: Urology / Gastroenterology.

phase 3 Anticholinergic agent Muscarinic acetylcholine receptors (M1-M5, primarily M3) Urology / Gastroenterology Small molecule

Target snapshot

OROS® oxybutynin (OROS® oxybutynin) — Alza Corporation, DE, USA. OROS oxybutynin is an anticholinergic agent that blocks muscarinic receptors in the bladder smooth muscle, reducing involuntary contractions and increasing bladder capacity.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
OROS® oxybutynin TARGET	OROS® oxybutynin	Alza Corporation, DE, USA	phase 3	Anticholinergic agent	Muscarinic acetylcholine receptors (M1-M5, primarily M3)
Oxybutynin chloride, extended-release	Oxybutynin chloride, extended-release	US Department of Veterans Affairs	marketed	Anticholinergic agent	M3 muscarinic acetylcholine receptor
Neostigmine+Glycopyrronium	Neostigmine+Glycopyrronium	Pusan National University Yangsan Hospital	marketed	Acetylcholinesterase inhibitor + Anticholinergic agent	Acetylcholinesterase; Muscarinic acetylcholine receptors
Solifenacin with vaginal estrogen cream	Solifenacin with vaginal estrogen cream	Mackay Memorial Hospital	marketed	Anticholinergic agent (solifenacin) + topical estrogen (vaginal cream)	M3 muscarinic receptor (solifenacin); estrogen receptor (vaginal estrogen)
Trospium Cl	Trospium Cl	Toronto Rehabilitation Institute	marketed	Anticholinergic agent	Muscarinic acetylcholine receptors (M3 subtype)
Active B&O suppository of belladonna	Active B&O suppository of belladonna	Edgar LeClaire, MD	marketed	Anticholinergic agent	Muscarinic acetylcholine receptors (M1-M5)
Neostigmine and Glycopyrrolate	Neostigmine and Glycopyrrolate	James J. Peters Veterans Affairs Medical Center	marketed	Cholinesterase inhibitor with anticholinergic agent	Acetylcholinesterase (neostigmine); Muscarinic acetylcholine receptors (glycopyrrolate)

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)

No upcoming patent expiries for this set.

Sponsor landscape (Anticholinergic agent class)

1. Repurposed Therapeutics, Inc. · 2 drugs in this class
2. University of Iowa · 2 drugs in this class
3. Alza Corporation, DE, USA · 2 drugs in this class
4. Janssen-Cilag Ltd.,Thailand · 1 drug in this class
5. Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · 1 drug in this class
6. Rutgers, The State University of New Jersey · 1 drug in this class
7. Stony Brook University · 1 drug in this class
8. Toronto Rehabilitation Institute · 1 drug in this class
9. US Department of Veterans Affairs · 1 drug in this class
10. University of California, Davis · 1 drug in this class