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Generated: August 21, 2018

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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.

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

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

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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 ➤ Try a Free Trial
7,214,381 Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels ➤ Try a Free Trial
7,335,379 Transdermal pharmaceutical formulation for minimizing skin residues ➤ Try a Free Trial
7,387,788 Pharmaceutical compositions of nicotine and methods of use thereof ➤ Try a Free Trial
7,404,965 Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels ➤ Try a Free Trial
7,470,433 Formulations for transdermal or transmucosal application ➤ Try a Free Trial
8,652,491 Transdermal compositions for anticholinergic agents ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for oxybutynin

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Merck
McKinsey
Fuji
Covington
US Army
Healthtrust
Colorcon

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