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Last Updated: December 6, 2023

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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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 Loss of Exclusivity (LOE) 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 ⤷  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

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

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.

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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Medtronic
Colorcon
Baxter
McKinsey

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.