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XOPENEX Drug Profile
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The generic ingredient in XOPENEX is levalbuterol tartrate. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.
Summary for Tradename: XOPENEX
| Patents: | 4 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 8 |
| Drug Prices: : | see details |
Pharmacology for Tradename: XOPENEX
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
Clinical Trials for: XOPENEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | RX | Yes | 6,451,289 | Mar 21, 2021 | ||||||||||||||||||||
Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-004 | Jul 18, 2003 | RX | Yes | 6,451,289 | Mar 21, 2021 | Y | |||||||||||||||||||
Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | RX | Yes | Jan 22, 2018 | |||||||||||||||||||||
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Expired Patents for Tradename: XOPENEX
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | 5,362,755 | <disabled> | ||||||||||||||||||||||
Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | 5,362,755 | <disabled> | ||||||||||||||||||||||
Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | 5,844,002 | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: XOPENEX
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| levalbuterol tartrate | Inhalation Aerosol | 0.045 mg/actuation | Xopenex | 2/27/2012 |
| levalbuterol hydrochloride | Inhalation Solution | 0.0025 | Xopenex | 5/23/2006 |
| levalbuterol hydrochloride | Inhalation Solution | 0.0103%, 0.021% and 0.042% | Xopenex | 6/20/2005 |
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