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Last Updated: August 14, 2020

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OXYBUTYNIN CHLORIDE Drug Profile

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Which patents cover Oxybutynin Chloride, and when can generic versions of Oxybutynin Chloride launch?

Oxybutynin Chloride is a drug marketed by Par Pharm Inc, Anda Repository, Lannett Co Inc, Pharm Assoc, Wockhardt Bio Ag, 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-one NDAs.

The generic ingredient in OXYBUTYNIN CHLORIDE is oxybutynin chloride. There are sixteen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.

US ANDA Litigation and Generic Entry Outlook for Oxybutynin Chloride

A generic version of OXYBUTYNIN CHLORIDE was approved as oxybutynin chloride by TEVA PHARMS USA on November 14th, 1988.

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Drug patent expirations by year for OXYBUTYNIN CHLORIDE
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
Novitium Pharma OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 209823-001 Oct 23, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 202332-001 Jun 26, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Upsher Smith Labs OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 074625-001 Jul 31, 1996 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

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