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Last Updated: December 12, 2019

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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 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, Anda Repository, Lannett Co Inc, Pharm Assoc, Wockhardt Bio Ag, Janssen Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Amneal Pharms, Impax Pharms, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Unique Pharm Labs, Zydus Pharms, Abhai Llc, Arise, Athem, Emcure Pharms Ltd, Novitium Pharma, Quantum Pharmics, Teva Pharms Usa, Tulex Pharms Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms, and Watson Labs, and is included in thirty-six NDAs. There are twelve 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 sixteen patent family members in twenty-two countries.

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

Drug Prices for oxybutynin

See drug prices for oxybutynin

Drug Sales Revenue Trends for oxybutynin

See drug sales revenues for oxybutynin

Recent Clinical Trials for oxybutynin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of ArizonaPhase 2
National Heart, Lung, and Blood Institute (NHLBI)Phase 2
Kaohsiung Medical University Chung-Ho Memorial HospitalN/A

See all oxybutynin clinical trials

Recent Litigation for oxybutynin

Identify potential future generic entrants

District Court Litigation
Case NameDate
Auxilium Pharmaceuticals v. Upsher-Smith Laboratories2014-01-29
Abbott Products Inc. v. Teva Pharamceuticals USA, Inc.2011-04-29

See all oxybutynin litigation

Pharmacology for oxybutynin
Synonyms for oxybutynin
(+/-)-oxybutynin
(+/-)-OXYBUTYNIN(Hydrochloride form)
(R)-4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate
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
BCP12179
BDBM50165019
Benzeneacetic acid, a-cyclohexyl-a-hydroxy-,4-(diethylamino)-2-butynyl ester
Benzeneacetic acid, alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl ester
BPBio1_000214
BRD-A65013509-003-03-8
BRD-A65013509-003-13-7
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
DB01062
Ditropan
Ditropan Xl
Ditropan;Lyrinel XL;Oxytrol
DTXSID0023406
FT-0082890
FT-0603679
GTPL359
HSDB 3270
HY-B0267
I06-2117
K-9978
KS-00000GVI
KS-5221
L000923
Lopac0_000923
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
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)
Oxytrol for Women
Pollakisu
Prestwick0_000287
Prestwick1_000287
Prestwick2_000287
Prestwick3_000287
s1754
SBI-0050898.P002
SC-26752
SCHEMBL2992
SMR001550466
SPBio_002413
ST24048863
SW196787-3
transdermal patch
XIQVNETUBQGFHX-UHFFFAOYSA-N
Paragraph IV (Patent) Challenges for OXYBUTYNIN
Tradename Dosage Ingredient NDA Submissiondate
OXYTROL FILM, EXTENDED RELEASE;TRANSDERMAL oxybutynin 021351 2008-08-19

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
Osmotica Pharm Us OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 078503-002 Feb 4, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Allergan Sales Llc OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan Sales Llc GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Impax Pharms OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 076745-001 Nov 9, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Unique Pharm Labs OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 206121-003 May 27, 2016 AB RX No 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

Expired US Patents for oxybutynin

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

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