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Last Updated: March 4, 2021

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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 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, Rubicon, Unique Pharm Labs, Zydus Pharms, Abhai Llc, Emcure Pharms Ltd, Eywa, Leading Pharma Llc, Novast Labs, Novitium Pharma, Quantum Pharmics, Rising, Strides Pharma, Teva Pharms Usa, Tulex Pharms Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms, and Watson Labs, and is included in thirty-seven 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-two 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 Cancer Institute (NCI)Phase 2
Alliance for Clinical Trials in OncologyPhase 2
National Institute on Disability, Independent Living, and Rehabilitation ResearchPhase 2

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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
Allergan GELNIQUE oxybutynin chloride GEL;TRANSDERMAL 022204-001 Jan 27, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novast Labs OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 210611-001 Oct 30, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Osmotica Pharm Us OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 078503-001 Feb 4, 2009 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 020897-001 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
Janssen Pharms DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897-001 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:

Colorcon
Boehringer Ingelheim
Dow
Harvard Business School
Medtronic
Moodys

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