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Generated: August 21, 2018

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Oxybutynin chloride - Generic Drug Details

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

Oxybutynin chloride is the generic ingredient in four branded drugs marketed by 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 twenty-eight NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Oxybutynin chloride has eighty-one patent family members in twenty countries.

There are sixteen drug master file entries for oxybutynin chloride. Fifty-four suppliers are listed for this compound.

Pharmacology for oxybutynin chloride
Synonyms for oxybutynin chloride
(R,S) - Oxybutynin Hydrochloride
(R)-|A-Phenylcyclohexaneglycolic Acid 4-(Diethylamino)-2-butynyl Ester, Hydrochloride
(R)-OXYBUTYNIN HYDROCHLORIDE
(S)-|A-Phenylcyclohexaneglycolic Acid 4-(Diethylamino)-2-butynyl Ester, Hydrochloride
(s)-oxybutynin chloride
1508-65-2
2-cyclohexyl-2-hydroxy-2-phenylacetic acid 4-(diethylamino)but-2-ynyl ester hydrochloride
4-(Diethylamino)-2-butynyl (+-)-alpha-phenylcyclohexaneglycolate hydrochloride
4-(Diethylamino)-2-butynyl alpha-phenylcyclohexaneglycolate hydrochloride
4-(diethylamino)but-2-yn-1-yl 2-cyclohexyl-2-hydroxy-2-phenylacetate hydrochloride
4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenyl-acetate hydrochloride
4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate hydrochloride
4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate, chloride
4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate;hydrochloride
4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-oxidanyl-2-phenyl-ethanoate hydrochloride
4-(Diethylamino)but-2-ynyl cyclohexylphenylglycolate hydrochloride
4-Diethylamino-2-butynyl phenyl(cyclohexyl)glycolate hydrochloride
5633-20-5 (Parent)
A809082
AC1L3M7P
AK142874
AKOS015895349
alpha-Phenylcyclohexaneglycolic acid 4-(diethylamino)-2-butynyl ester hydrochloride
AN-49346
API0003718
Benzeneacetic acid, alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl ester hydrochloride
Benzeneacetic acid, alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl ester hydrochloride, (+-)-
BG0595
C-21602
C22H31NO3.HCl
C22H32ClNO3
CAS-1508-65-2
CCG-213420
CHEBI:7857
CHEMBL1133
CPD000058490
CS-2256
CTK8G2229
Cyclohexaneglycolic acid, alpha-phenyl-, 4-(diethylamino)-2-butynyl ester, hydrochloride
D00722
D05KZK
D0R1DH
Ditropan (TN)
Ditropan Xl
DL-06003
Dridase
DSSTox_CID_25356
DSSTox_GSID_45356
DSSTox_RID_80822
DTXSID3045356
EINECS 216-139-7
EU-0100923
FT-0082889
FT-0603563
Gelnique
Gelnique (TN)
H33O205
H815
HMS1568J16
HOB-294
HY-B0267A
I06-0708
J-008750
J10411
Jsp002882
KS-00000ZDA
KS-1377
LP00923
LP052649
LS-56862
MCULE-5193326065
MFCD00072150
MJ 4309-1
MJ-4309-1
MLS000069688
MLS001148211
MLS002222232
MolPort-003-666-668
NC00580
NCGC00016583-01
NCGC00094234-01
NCGC00094234-02
NCGC00261608-01
NSC-759108
NSC759108
O 2881
Opera_ID_1330
OR009708
OR206939
Oxibutinina hydrochloride
Oxybutynin (chloride)
Oxybutynin chloride (USP)
Oxybutynin chloride [USAN:USP]
Oxybutynin chloride [USAN]
Oxybutynin chloride, >=98% (TLC), powder
Oxybutynin chloride, meets EP, USP testing specifications
Oxybutynin chloride, United States Pharmacopeia (USP) Reference Standard
Oxybutynin HCl
Oxybutynin hydrochloride
Oxybutynin hydrochloride (JAN)
Oxybutynin hydrochloride (transdermal patch, overactive bladder)
Oxybutynin hydrochloride (transdermal patch, overactive bladder), Hisamitsu
Oxybutynin hydrochloride, European Pharmacopoeia (EP) Reference Standard
Oxybutyninhydrochloride
Pharmakon1600-01505399
Prestwick_621
REGID_for_CID_91505
s3117
SAM002564226
SC-18892
SCHEMBL25751
SMR000058490
SMT-D002
SR-01000000184
SR-01000000184-2
ST24048864
ST51015085
SWIJYDAEGSIQPZ-UHFFFAOYSA-N
Tox21_110507
Tox21_500923
Tropax
VA11467

US Patents and Regulatory Information for oxybutynin chloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharm Assoc OXYBUTYNIN CHLORIDE oxybutynin chloride SYRUP;ORAL 075137-001 Dec 18, 1998 AA RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Zydus Pharms Usa Inc OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 202332-002 Jun 26, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Amneal Pharms OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 204010-001 Nov 23, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Upsher-smith Labs OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 074625-001 Jul 31, 1996 AB RX No No ➤ 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 chloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-003 Jun 22, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-001 Dec 16, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-002 Dec 16, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-001 Dec 16, 1998 ➤ 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 chloride

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
6,743,441 Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy ➤ Try a Free Trial
7,081,249 Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy ➤ Try a Free Trial
7,081,250 Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy ➤ Try a Free Trial
7,081,251 Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Daiichi Sankyo
Healthtrust
Harvard Business School
Colorcon
Teva
McKinsey
US Department of Justice
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.