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Last Updated: August 2, 2021

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OXYBUTYNIN - Generic Drug Details

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

Oxybutynin is the generic ingredient in eight branded drugs marketed by Barr Labs Div Teva, 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, Appco, Emcure Pharms Ltd, Eywa, Leading Pharma Llc, Novast Labs, Novitium Pharma, Quantum Pharmics, Strides Pharma, Teva Pharms Usa, Tulex Pharms Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms, and Watson Labs, and is included in forty-one NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Oxybutynin has fifty-five patent family members in twenty countries.

There are sixteen drug master file entries for oxybutynin. One supplier is listed for this compound.

Drug Prices for OXYBUTYNIN

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Drug Sales Revenue Trends for OXYBUTYNIN

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Recent Clinical Trials for OXYBUTYNIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
China Medical University HospitalPhase 4
Alliance for Clinical Trials in OncologyPhase 2
National Cancer Institute (NCI)Phase 2

See all OXYBUTYNIN clinical trials

Pharmacology for OXYBUTYNIN
Paragraph IV (Patent) Challenges for OXYBUTYNIN
Tradename Dosage Ingredient NDA Submissiondate
OXYTROL FILM, EXTENDED RELEASE;TRANSDERMAL oxybutynin 021351 2008-08-19

US Patents and Regulatory Information for OXYBUTYNIN

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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Tulex Pharms Inc OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 210125-001 Sep 6, 2018 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Rubicon OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 214415-003 Oct 27, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan GELNIQUE 3% oxybutynin GEL, METERED;TRANSDERMAL 202513-001 Dec 7, 2011 ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003 ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan OXYTROL oxybutynin FILM, EXTENDED RELEASE;TRANSDERMAL 021351-002 Feb 26, 2003 ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan GELNIQUE 3% oxybutynin GEL, METERED;TRANSDERMAL 202513-001 Dec 7, 2011 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Dow
Moodys
McKinsey
McKesson
AstraZeneca

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