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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020837

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NDA 020837 describes XOPENEX, which is a drug marketed by Oak Pharms Inc and Sunovion and is included in two NDAs. It is available from three suppliers. There are three patents protecting this drug and three Paragraph IV challenges. Additional details are available on the XOPENEX profile page.

The generic ingredient in XOPENEX is levalbuterol tartrate. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.
Summary for 020837
Tradename:XOPENEX
Applicant:Oak Pharms Inc
Ingredient:levalbuterol hydrochloride
Patents:1
Pharmacology for NDA: 020837
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 020837
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837 NDA Akorn, Inc. 17478-171 17478-171-30 30 POUCH in 1 CARTON (17478-171-30) > 1 VIAL, SINGLE-DOSE in 1 POUCH (17478-171-01) > .5 mL in 1 VIAL, SINGLE-DOSE
XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837 NDA Akorn, Inc. 17478-172 17478-172-24 2 POUCH in 1 CARTON (17478-172-24) > 12 VIAL, SINGLE-DOSE in 1 POUCH (17478-172-12) > 3 mL in 1 VIAL, SINGLE-DOSE
Paragraph IV (Patent) Challenges for 020837
Tradename Dosage Ingredient NDA Submissiondate
XOPENEX SOLUTION;INHALATION levalbuterol hydrochloride 020837 2006-05-23
XOPENEX SOLUTION;INHALATION levalbuterol hydrochloride 020837 2005-06-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Mar 25, 1999TE:ANRLD:Yes
Patent:  Start TrialPatent Expiration:Mar 21, 2021Product Flag?Substance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.042% BASE
Approval Date:Mar 25, 1999TE:ANRLD:Yes
Patent:  Start TrialPatent Expiration:Mar 21, 2021Product Flag?Substance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.0103% BASE
Approval Date:Jan 30, 2002TE:ANRLD:Yes
Patent:  Start TrialPatent Expiration:Mar 21, 2021Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 020837

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003   Start Trial   Start Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003   Start Trial   Start Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999   Start Trial   Start Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003   Start Trial   Start Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999   Start Trial   Start Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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