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XOPENEX HFA Drug Profile
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» See Plans and PricingWhich 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.
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.
US ANDA Litigation and 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 2017 were $21mm indicating the motivation for generic entry (peak sales were $114mm in 2012).
There have been eleven 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 |
| Suppliers / Packagers: | 4 |
| 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 |
| DailyMed Link: | XOPENEX HFA at DailyMed |
See drug prices for XOPENEX HFA
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 |
Recent Litigation for XOPENEX HFA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Cipla Ltd. v. Sunovion Pharmaceuticals Inc. | 2015-05-26 |
| Celgard, LLC v. Sumitomo Chemical Co., Ltd. | 2013-02-22 |
| Sunovion Pharmaceuticals Inc. v. Watson Pharmaceuticals Inc. | 2012-07-27 |
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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Sunovion | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 |
|---|---|---|---|---|---|---|---|
| Sunovion | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | Start Trial | Start Trial |
| Sunovion | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | Start Trial | Start Trial |
| Sunovion | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | Start Trial | Start Trial |
| Sunovion | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | Start Trial | Start Trial |
| Sunovion | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | Start Trial | Start Trial |
| Sunovion | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | Start Trial | Start Trial |
| Sunovion | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for XOPENEX HFA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 80497 | Start Trial |
| South Korea | 0154116 | Start Trial |
| Austria | 135908 | Start Trial |
| Germany | 60336089 | Start Trial |
| Austria | 324364 | Start Trial |
| Denmark | 595789 | Start Trial |
| Cyprus | 1111330 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
