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Last Updated: April 20, 2024

OXYBUTYNIN Drug Patent Profile

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When do Oxybutynin patents expire, and when can generic versions of Oxybutynin launch?

Oxybutynin is a drug marketed by Barr Labs Div Teva, Chartwell Rx, Lannett Co Inc, Pharm Assoc, Pharmobedient Cnsltg, Accord Hlthcare, Ajanta Pharma Ltd, Amneal Pharms, Bionpharma, Impax Pharms, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Rubicon, Unique, Zydus Pharms, Abhai Llc, Avet Lifesciences, Beximco Pharms Usa, Eywa, Leading, Novast Labs, Novitium Pharma, Quantum Pharmics, Rising, Strides Pharma, Teva Pharms Usa, Tulex Pharms Inc, Upsher Smith Labs, Usl Pharma, and Watson Labs. and is included in thirty-five NDAs.

The generic ingredient in OXYBUTYNIN is oxybutynin chloride. There are sixteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Oxybutynin

A generic version of OXYBUTYNIN was approved as oxybutynin chloride by TEVA PHARMS USA on November 14^th, 1988.

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Summary for OXYBUTYNIN

US Patents:	0
Applicants:	31
NDAs:	35
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	94
Patent Applications:	3,929
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for OXYBUTYNIN
Drug Sales Revenues:	Drug sales revenues for OXYBUTYNIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OXYBUTYNIN
DailyMed Link:	OXYBUTYNIN at DailyMed

Drug patent expirations by year for OXYBUTYNIN

Drug Prices for OXYBUTYNIN

Recent Clinical Trials for OXYBUTYNIN

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Sponsor	Phase
Cairo University	Phase 3
Benha University	N/A
Science Valley Research Institute	Phase 2

See all OXYBUTYNIN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for OXYBUTYNIN

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for OXYBUTYNIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OXYTROL	Transdermal System Extended-release	oxybutynin	3.9 mg/24 hrs	021351	1	2008-08-19

US Patents and Regulatory Information for OXYBUTYNIN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Beximco Pharms Usa	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	213550-001	Jul 14, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rubicon	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	214415-003	Oct 27, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Strides Pharma	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	075079-001	Oct 31, 1997	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novitium Pharma	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	209823-001	Oct 23, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Strides Pharma	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	208165-001	Dec 17, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	072485-001	Apr 19, 1989		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Osmotica Pharm Us	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	078503-002	Feb 4, 2009	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for OXYBUTYNIN

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva B.V.	Kentera (previously Oxybutynin Nicobrand)	oxybutynin	EMEA/H/C/000532 Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.	Authorised	no	no	no	2004-06-15
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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