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Last Updated: August 11, 2020

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Oxybutynin chloride - Generic Drug Details

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What are the generic sources for oxybutynin chloride and what is the scope of patent protection?

Oxybutynin chloride is the generic ingredient in four branded drugs marketed by Allergan, 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, Bionpharma Inc, Impax Pharms, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Unique Pharm Labs, Zydus Pharms, Abhai Llc, Arise, Athem, Emcure Pharms Ltd, Leading Pharma Llc, Novast Labs, 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-five NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are sixteen drug master file entries for oxybutynin chloride. Forty-four 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
National Institute on Disability, Independent Living, and Rehabilitation ResearchPhase 2
Kessler FoundationPhase 2
National Cancer Institute (NCI)Phase 3

See all oxybutynin chloride clinical trials

Pharmacology for oxybutynin chloride
Paragraph IV (Patent) Challenges for OXYBUTYNIN CHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
GELNIQUE GEL;TRANSDERMAL oxybutynin chloride 022204 2014-06-19
DITROPAN XL TABLET, EXTENDED RELEASE;ORAL oxybutynin chloride 020897

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 074997-001 Oct 15, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 072485-001 Apr 19, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Ortho Mcneil Janssen DITROPAN oxybutynin chloride SYRUP;ORAL 018211-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bionpharma Inc OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 210717-002 Dec 17, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Osmotica Pharm Us OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 078503-003 Feb 4, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Unique Pharm Labs OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 206121-002 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 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   Start Trial   Start Trial
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-001 Dec 16, 1998   Start Trial   Start Trial
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 020897-001 Dec 16, 1998   Start Trial   Start Trial
Allergan GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009   Start Trial   Start Trial
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-003 Jun 22, 1999   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:

Johnson and Johnson
Medtronic
AstraZeneca
Colorcon
Express Scripts
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 verification 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.