DrugPatentWatch Database Preview
XOPENEX Drug Profile
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Which patents cover Xopenex, and what generic alternatives are available?
Xopenex is a drug marketed by Akorn and Sunovion and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.
The generic ingredient in XOPENEX 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
There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for XOPENEX
| US Patents: | 1 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 36 |
| Clinical Trials: | 6 |
| Patent Applications: | 4,233 |
| Drug Prices: | Drug price information for XOPENEX |
| Drug Sales Revenues: | Drug sales revenues for XOPENEX |
| What excipients (inactive ingredients) are in XOPENEX? | XOPENEX excipients list |
| DailyMed Link: | XOPENEX at DailyMed |
Recent Clinical Trials for XOPENEX
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
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
Paragraph IV (Patent) Challenges for XOPENEX
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| XOPENEX | SOLUTION;INHALATION | levalbuterol hydrochloride | 020837 | 2006-05-23 |
| XOPENEX | SOLUTION;INHALATION | levalbuterol hydrochloride | 020837 | 2005-06-20 |
US Patents and Regulatory Information for XOPENEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | AN | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-004 | Jul 18, 2003 | AN | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | ||
| Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | AN | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | AN | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | 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 | |||
| 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 | ||
| >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
International Patents for XOPENEX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 69209490 | Try Before You Buy |
| Spain | 2088152 | Try Before You Buy |
| Norway | 931393 | Try Before You Buy |
| Japan | 3630679 | Try Before You Buy |
| Hong Kong | 161896 | Try Before You Buy |
| Taiwan | 231318 | Try Before You Buy |
| Japan | H05503102 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
