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 are two patents 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. Five suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Xopenex Hfa

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 8, 2023. This may change due to patent challenges or generic licensing.

Annual sales in 2019 were $10mm indicating the motivation for generic entry (peak sales were $114mm in 2012).

There have been four 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:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	6
Patent Applications:	3
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for XOPENEX HFA

Generic Entry Date for XOPENEX HFA^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 021730 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.

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 two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XOPENEX HFA is ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XOPENEX HFA

Levalbuterol salt
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS

Levalbuterol salt
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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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	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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	⤷ Try a Trial	⤷ Try a Trial
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	⤷ Try a Trial	⤷ Try a Trial
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	⤷ Try a Trial	⤷ Try a Trial
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	⤷ Try a Trial	⤷ Try a Trial
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	⤷ Try a Trial	⤷ Try a Trial
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	⤷ Try a Trial	⤷ Try a Trial
>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
Japan	3172190		⤷ Try a Trial
Canada	2166970	GARNITURES D'ETANCHEITE POUR BOMBES AEROSOLS (SEALS FOR USE IN AN AEROSOL DELIVERY DEVICE)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	9502651		⤷ Try a Trial
Japan	H02200627	MEDICAL AEROSOL PREPARATION	⤷ Try a Trial
Austria	498604		⤷ Try a Trial
Germany	9422364		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration