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
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

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
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 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
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 |