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Last Updated: June 28, 2022

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 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

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Drug patent expirations by year for XOPENEX HFA
Drug Prices for XOPENEX HFA

See drug prices for XOPENEX HFA

Drug Sales Revenue Trends for XOPENEX HFA

See drug sales revenues for XOPENEX HFA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for XOPENEX HFA
Generic Entry Date for XOPENEX HFA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Henry Ford Health SystemPhase 4
Genesys Regional Medical CenterPhase 4
Ascension Genesys HospitalPhase 4

See all XOPENEX HFA clinical trials

Pharmacology for XOPENEX HFA
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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS

Levalbuterol salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Sunovion XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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

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

Patent: 03295695
Estimated Expiration: See Plans and Pricing

Austria

Patent: 4364
Estimated Expiration: See Plans and Pricing

Patent: 8604
Estimated Expiration: See Plans and Pricing

Canada

Patent: 07572
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 11330
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 72622
Estimated Expiration: See Plans and Pricing

Patent: 71942
Estimated Expiration: See Plans and Pricing

Patent: 92584
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 72622
Estimated Expiration: See Plans and Pricing

Patent: 71942
Estimated Expiration: See Plans and Pricing

Patent: 92584
Estimated Expiration: See Plans and Pricing

Germany

Patent: 304900
Estimated Expiration: See Plans and Pricing

Patent: 336089
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8739
Estimated Expiration: See Plans and Pricing

Patent: 2369
Estimated Expiration: See Plans and Pricing

Japan

Patent: 70960
Estimated Expiration: See Plans and Pricing

Patent: 06509802
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05006087
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1168
Estimated Expiration: See Plans and Pricing

Norway

Patent: 1649
Estimated Expiration: See Plans and Pricing

Patent: 053339
Estimated Expiration: See Plans and Pricing

Poland

Patent: 2725
Estimated Expiration: See Plans and Pricing

Patent: 7336
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 72622
Estimated Expiration: See Plans and Pricing

Patent: 71942
Estimated Expiration: See Plans and Pricing

Patent: 92584
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 72622
Estimated Expiration: See Plans and Pricing

Patent: 71942
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1166955
Estimated Expiration: See Plans and Pricing

Patent: 050088307
Estimated Expiration: See Plans and Pricing

Patent: 080103614
Estimated Expiration: See Plans and Pricing

Patent: 100080865
Estimated Expiration: See Plans and Pricing

Spain

Patent: 63051
Estimated Expiration: See Plans and Pricing

Patent: 61172
Estimated Expiration: See Plans and Pricing

Patent: 26648
Estimated Expiration: See Plans and Pricing

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.