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Last Updated: December 5, 2019

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Details for New Drug Application (NDA): 021730

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NDA 021730 describes XOPENEX HFA, which is a drug marketed by Sunovion and is included in one NDA. It is available from four suppliers. There are two patents protecting this drug. Additional details are available on the XOPENEX HFA profile page.

The generic ingredient in XOPENEX HFA 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 021730
Tradename:XOPENEX HFA
Applicant:Sunovion
Ingredient:levalbuterol tartrate
Patents:2
Generic Entry Opportunity Date for 021730
Generic Entry Date for 021730*:
Constraining patent/regulatory exclusivity:
Dosage:
AEROSOL, METERED;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 021730
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 021730
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-2927 0591-2927-54 1 INHALER in 1 CARTON (0591-2927-54) > 200 AEROSOL, METERED in 1 INHALER
XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730 NDA AUTHORIZED GENERIC Proficient Rx LP 63187-876 63187-876-15 1 INHALER in 1 CARTON (63187-876-15) > 200 AEROSOL, METERED in 1 INHALER
Paragraph IV (Patent) Challenges for 021730
Tradename Dosage Ingredient NDA Submissiondate
XOPENEX HFA AEROSOL, METERED;INHALATION levalbuterol tartrate 021730 2012-02-27

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrengthEQ 0.045MG BASE/INH
Approval Date:Mar 11, 2005TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 8, 2024Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS
Patent:  Start TrialPatent Expiration:Dec 8, 2023Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021730

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005   Start Trial   Start Trial
Sunovion XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005   Start Trial   Start Trial
Sunovion XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005   Start Trial   Start Trial
Sunovion XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005   Start Trial   Start Trial
Sunovion XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005   Start Trial   Start Trial
Sunovion XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005   Start Trial   Start Trial
Sunovion XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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