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Serving 500+ biopharmaceutical companies globally:

Chubb
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Fuji
US Department of Justice
Healthtrust
McKinsey
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Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021351

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NDA 021351 describes OXYTROL, which is a drug marketed by Allergan Sales Llc and is included in two NDAs. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OXYTROL profile page.

The generic ingredient in OXYTROL is oxybutynin. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the oxybutynin profile page.

Summary for NDA: 021351

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:6
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021351

Suppliers and Packaging for NDA: 021351

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYTROL
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL 021351 NDA Actavis Pharma, Inc. 52544-920 52544-920-08 8 POUCH in 1 BOX (52544-920-08) > 1 PATCH in 1 POUCH (52544-920-54) > 4 d in 1 PATCH

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength3.9MG/24HR
Approval Date:Feb 26, 2003TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Apr 26, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE
Patent:► SubscribePatent Expiration:Apr 26, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE
Patent:► SubscribePatent Expiration:Apr 26, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE

Expired Orange Book Patents for NDA: 021351

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc
OXYTROL
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL021351-002Feb 26, 2003► Subscribe► Subscribe
Allergan Sales Llc
OXYTROL
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL021351-002Feb 26, 2003► Subscribe► Subscribe
Allergan Sales Llc
OXYTROL
oxybutynin
FILM, EXTENDED RELEASE;TRANSDERMAL021351-002Feb 26, 2003► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Citi
Farmers Insurance
Merck
Deloitte
Dow
Boehringer Ingelheim
Medtronic
Julphar
McKesson

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