XOPENEX HFA Drug Patent Profile

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

Xopenex Hfa is a drug marketed by Sunovion 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. Four 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 six 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

Summary for XOPENEX HFA

International Patents:	36
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	6
Patent Applications:	1
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

See drug prices for XOPENEX HFA

See drug sales revenues for XOPENEX HFA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for XOPENEX HFA

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.

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

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

Expired US Patents for XOPENEX HFA

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
Sunovion	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005
Sunovion	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005
Sunovion	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005
Sunovion	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005
Sunovion	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005
Sunovion	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005

International Patents for XOPENEX HFA

When does loss-of-exclusivity occur for XOPENEX HFA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Canada

Cyprus

Denmark

European Patent Office

Germany

Israel

Japan

Mexico

New Zealand

Norway

Poland

Portugal

Slovenia

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	1671942
South Korea	0154116
European Patent Office	0995434
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)
Spain	2045470
Austria	324364
New Zealand	243056	AEROSOL FORMULATION CONTAINING A MEDICAMENT, TETRAFLUOROETHANE AND ISOPROPYL MYRISTATE