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
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 |


See drug prices 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
Sponsor | Phase |
---|---|
Henry Ford Health System | Phase 4 |
Genesys Regional Medical Center | Phase 4 |
Ascension Genesys Hospital | Phase 4 |
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
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 |