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XOPENEX HFA Drug Patent Profile

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Which patents cover Xopenex Hfa, and when can generic versions of Xopenex Hfa launch?

Xopenex Hfa is a drug marketed by Lupin and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-six patent family members in eighteen countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Xopenex Hfa

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for XOPENEX HFA

International Patents:	36
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	6
Drug Prices:	Drug price information for XOPENEX HFA
Drug Sales Revenues:	Drug sales revenues for XOPENEX HFA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XOPENEX HFA
What excipients (inactive ingredients) are in XOPENEX HFA?	XOPENEX HFA excipients list
DailyMed Link:	XOPENEX HFA at DailyMed

Drug patent expirations by year for XOPENEX HFA

Recent Clinical Trials for XOPENEX HFA

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

Sponsor	Phase
Henry Ford Health System	Phase 4
Genesys Regional Medical Center	Phase 4
Ascension Genesys Hospital	Phase 4

See all XOPENEX HFA clinical trials

Pharmacology for XOPENEX HFA

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

Paragraph IV (Patent) Challenges for XOPENEX HFA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XOPENEX HFA	Inhalation Aerosol	levalbuterol tartrate	0.045 mg/actuation	021730	1	2012-02-27

US Patents and Regulatory Information for XOPENEX HFA

XOPENEX HFA is protected by one US patents.

Patents protecting XOPENEX HFA

Levalbuterol salt
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>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 XOPENEX HFA

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

International Patents for XOPENEX HFA

See the table below for patents covering XOPENEX HFA around the world.

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Country	Patent Number	Title	Estimated Expiration
Israel	212369	לבלבוטרול l-טרטראט בצורה קריסטלית, תהליך לייצורו, ותכשיר תרסיס המכיל אותו (Levalbuterol l-tartrate in crystalline form, a process for its preparation and aerosol formulation comprising it)	⤷ Sign Up
Canada	2507572	SEL DE LEVALBUTEROL (LEVALBUTEROL SALT)	⤷ Sign Up
Canada	2073181	R(-) ALBUTEROL OPTIQUEMENT PUR POUR LE TRAITEMENT DE L'ASTHME (OPTICALLY PURE R(-) ALBUTEROL FOR TREATING ASTHMA)	⤷ Sign Up
Australia	7174191		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration