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Generated: January 21, 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 five 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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Mar 25, 1999TE:ANRLD:Yes
Regulatory Exclusivity Expiration:Jan 22, 2018
Regulatory Exclusivity Use:REVISIONS TO THE LABELING BASED ON THE OUTCOMES OF PEDIATRIC STUDIES CONDUCTED TO ASSESS THE SAFETY AND EFFICACY OF XOPENEX IN SUBJECTS LESS THAN 6 YEARS OF AGE
Patent:➤ Try a Free 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
Regulatory Exclusivity Expiration:Jan 22, 2018
Regulatory Exclusivity Use:REVISIONS TO THE LABELING BASED ON THE OUTCOMES OF PEDIATRIC STUDIES CONDUCTED TO ASSESS THE SAFETY AND EFFICACY OF XOPENEX IN SUBJECTS LESS THAN 6 YEARS OF AGE

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 ➤ Try a Free Trial ➤ Try a Free Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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