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Oxybutynin - Generic Drug Details

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What are the generic drug sources for oxybutynin and what is the scope of oxybutynin freedom to operate?

Oxybutynin is the generic ingredient in eight branded drugs marketed by Barr Labs Div Teva, Allergan Sales Llc, Par Pharm Inc, Ortho Mcneil Janssen, Apotex Inc, Lannett Co Inc, Mikart, Pharm Assoc, Wockhardt Bio Ag, Janssen Pharms, Accord Hlthcare, Amneal Pharms, Impax Pharms, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Unique Pharm Labs, Zydus Pharms Usa Inc, Abhai Llc, Appco Pharma Llc, Novitium Pharma, Quantum Pharmics, Teva Pharms Usa, Upsher-smith Labs, Usl Pharma, Vintage Pharms, and Watson Labs, and is included in thirty-two NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Oxybutynin has one hundred and fifteen patent family members in twenty-two countries.

There are sixteen drug master file entries for oxybutynin. Two suppliers are listed for this compound.

Summary for oxybutynin

International Patents:	115
US Patents:	11
Tradenames:	8
Applicants:	27
NDAs:	32
Drug Master File Entries:	16
Suppliers / Packagers:	2
Bulk Api Vendors:	55
Clinical Trials:	73
Patent Applications:	5,229
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for oxybutynin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for oxybutynin
DailyMed Link:	oxybutynin at DailyMed

Pharmacology for oxybutynin

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Synonyms for oxybutynin

(+/-)-oxybutynin

(+/-)-OXYBUTYNIN(Hydrochloride form)

1508-65-2 (hydrochloride)

27815-EP2269989A1

27815-EP2275420A1

27815-EP2280008A2

27815-EP2298767A1

27815-EP2314587A1

4-(Diethylamino)-2-butynyl .alpha.-phenylcyclohexaneglycolate

4-(Diethylamino)-2-butynyl alpha-phenylcyclohexaneglycolic acid ester

4-(Diethylamino)-2-butynyl cyclohexyl(hydroxy)phenylacetate #

4-(diethylamino)-2-butynyl-alpha-cyclohexyl-alpha-hydroxybenzeneacetate

4-(diethylamino)-2-butynyl-alpha-phenylcyclohexaneglycolate

4-(diethylamino)but-2-yn-1-yl 2-cyclohexyl-2-hydroxy-2-phenylacetate

4-(diethylamino)but-2-yn-1-yl cyclohexyl(hydroxy)phenylacetate

4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenyl-acetate

4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate

4-Diethylamino-2-butinyl alpha-cyclohexylmandelat

4-Diethylamino-2-butynyl alpha-phenylcyclohexaneglycolate

4-diethylaminobut-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate

5633-20-5

633O205

AB0013281

AB2000274

AC-2153

AC1L1ILV

AK162584

AKOS015896242

AN-14276

Anturol

Anturol (TN)

API0007236

AX8146542

BDBM50165019

Benzeneacetic acid, alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl ester

BPBio1_000214

BRD-A65013509-003-03-8

BSPBio_000194

C-20821

C07360

CC-33425

CCG-205005

CCRIS 1923

CHEBI:7856

CHEMBL1231

CS-2255

Cyclohexaneglycolic acid, .alpha.-phenyl-, 4-(diethylamino)-2-butynyl ester

Cyclohexaneglycolic acid, alpha-phenyl-, 4-(diethylamino)-2-butynyl ester

Cystrin

D00465

D0F5LH

DB01062

Ditropan

Ditropan Xl

Ditropan;Lyrinel XL;Oxytrol

DR001867

DTXSID0023406

FT-0082890

FT-0603679

GTPL359

HSDB 3270

HY-B0267

I06-2117

K-9978

kentera

KS-00000GVI

KS-5221

L000923

Lopac0_000923

LP048773

LS-28714

Lyrinel XL

MCULE-3407007074

MFCD00865252

MLS006010052

MolPort-003-849-741

MRF-0000601

NCGC00015767-03

NCGC00015767-04

NCGC00015767-06

NCGC00015767-07

NCGC00015767-09

NCGC00089795-02

O222

OR285581

Oxibutinina

Oxibutinina [INN-Spanish]

Oxibutyninum

Oxybutinin

Oxybutynin (Ditropan)

Oxybutynin (USAN/INN)

Oxybutynin [USAN:INN:BAN]

Oxybutynin Base

oxybutynin topical gel

Oxybutynin transdermal

Oxybutynin transdermal patch

OXYBUTYNIN, Oxybutynin chloride

Oxybutynine

Oxybutynine [INN-French]

Oxybutyninum

Oxybutyninum [INN-Latin]

Oxytrol

Oxytrol (TN)

Pollakisu

Prestwick0_000287

Prestwick1_000287

Prestwick2_000287

Prestwick3_000287

s1754

SBI-0050898.P002

SC-26752

SCHEMBL2992

SMR001550466

SPBio_002413

ST24048863

transdermal patch

XIQVNETUBQGFHX-UHFFFAOYSA-N

US Patents and Regulatory Information for oxybutynin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abhai Llc	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET;ORAL	209335-001	Dec 22, 2017	AB	RX	No	No
Unique Pharm Labs	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	206121-001	May 27, 2016	AB	RX	No	No
Allergan Sales Llc	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013		OTC	Yes	Yes			Y
Accord Hlthcare	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	207138-003	Feb 29, 2016	AB	RX	No	No
Allergan Sales Llc	GELNIQUE	oxybutynin chloride	GEL;TRANSDERMAL	022204-001	Jan 27, 2009	AB	RX	Yes	Yes
Mylan Pharms Inc	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	076644-001	Nov 9, 2006	AB	RX	No	No
Wockhardt Bio Ag	OXYBUTYNIN CHLORIDE	oxybutynin chloride	SYRUP;ORAL	074868-001	Feb 12, 1997	AA	RX	No	Yes

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Expired US Patents for oxybutynin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan Sales Llc	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003
Allergan Sales Llc	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013
Allergan Sales Llc	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003
Allergan Sales Llc	OXYTROL FOR WOMEN	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	202211-001	Jan 25, 2013
Allergan Sales Llc	OXYTROL	oxybutynin	FILM, EXTENDED RELEASE;TRANSDERMAL	021351-002	Feb 26, 2003

Non-Orange Book US Patents for oxybutynin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,087,241	Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
7,214,381	Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels
7,335,379	Transdermal pharmaceutical formulation for minimizing skin residues
7,387,788	Pharmaceutical compositions of nicotine and methods of use thereof
7,404,965	Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels
7,470,433	Formulations for transdermal or transmucosal application
8,652,491	Transdermal compositions for anticholinergic agents

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International Patents for oxybutynin

Country	Document Number	Estimated Expiration
South Korea	20110043725
Japan	2017031191
Brazil	0110381
South Korea	20030031568
Austria	534373
European Patent Office	1992342
China	101305994