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XOPENEX HFA Drug 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. Three 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 2018 were $27mm 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: | 3 |
| Clinical Trials: | 6 |
| 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 |
| Fahim Khorfan, MD | 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 | NDA | Submissiondate |
|---|---|---|---|---|
| XOPENEX HFA | AEROSOL, METERED;INHALATION | levalbuterol tartrate | 021730 | 2012-02-27 |
US Patents and Regulatory Information for 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 | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Sunovion | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| >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 | Try Before You Buy | Try Before You Buy |
| Sunovion | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | Try Before You Buy | Try Before You Buy |
| Sunovion | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | Try Before You Buy | Try Before You Buy |
| Sunovion | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | Try Before You Buy | Try Before You Buy |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for XOPENEX HFA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 595789 | Try Before You Buy |
| South Korea | 20050088307 | Try Before You Buy |
| South Korea | 20100080865 | Try Before You Buy |
| Japan | 4570960 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
