Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: October 22, 2019

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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 freedom to operate?

Oxybutynin chloride is the generic ingredient in four branded drugs marketed by Allergan Sales Llc, Par Pharm Inc, Ortho Mcneil Janssen, Lannett Co Inc, Mikart, Pd Partners, 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, Appco Pharma Llc, Emcure Pharms Ltd, Invatech Pharma, 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-two NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

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

Drug Prices for oxybutynin chloride

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Drug Sales Revenue Trends for oxybutynin chloride

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Recent Clinical Trials for oxybutynin chloride

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SponsorPhase
Kessler FoundationPhase 2
National Institute on Disability, Independent Living, and Rehabilitation ResearchPhase 2
National Cancer Institute (NCI)Phase 3

See all oxybutynin chloride clinical trials

Recent Litigation for oxybutynin chloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Ultratec, Inc. v. CaptionCall, LLC2016-03-15
Purdue Pharma L.P. v. PAR Pharmaceutical, Inc.2013-05-17
Endo Pharmaceuticals Inc., and Grunenthal GbmH v. Teva Pharmaceuticals USA, Inc., and Barr Laboratories, Inc.2012-11-05

See all oxybutynin chloride litigation

Pharmacology for oxybutynin chloride
Synonyms for oxybutynin chloride
(R,S) - Oxybutynin Hydrochloride
(R)-|A-Phenylcyclohexaneglycolic Acid 4-(Diethylamino)-2-butynyl Ester, Hydrochloride
(R)-Oxybutynin Chloride
(S)-|A-Phenylcyclohexaneglycolic Acid 4-(Diethylamino)-2-butynyl Ester, Hydrochloride
(S)-4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate hydrochloride
1207344-05-5
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
AKOS015895349
alpha-Phenylcyclohexaneglycolic acid 4-(diethylamino)-2-butynyl ester hydrochloride
AN-49346
API0003718
BCP12138
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
Ditropan (TN)
Ditropan Xl
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
HY-B0267A
I06-0708
J-008750
J10411
Jsp002882
KS-00000ZDA
KS-1377
LP00923
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
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, British Pharmacopoeia (BP) Reference Standard
Oxybutynin hydrochloride, European Pharmacopoeia (EP) Reference Standard
Pharmakon1600-01505399
Prestwick_621
REGID_for_CID_91505
s3117
SAM002564226
SC-18892
SCHEMBL25751
SMR000058490
SR-01000000184
SR-01000000184-2
SR-01000000184-7
ST24048864
ST51015085
SW196787-4
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
Mylan Pharms Inc OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 076644-002 May 10, 2007 AB RX No No   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
Mikart OXYBUTYNIN CHLORIDE oxybutynin chloride SYRUP;ORAL 075039-001 Jan 29, 1999 DISCN 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 chloride

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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Colorcon
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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.