XOPENEX Drug Patent Profile
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Which patents cover Xopenex, and what generic alternatives are available?
Xopenex is a drug marketed by Akorn and Lupin and is included in two NDAs. There are two 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. Four suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.
DrugPatentWatch® Generic Entry Outlook for Xopenex
Annual sales in 2019 were $19mm indicating the motivation for generic entry (peak sales were $558mm in 2011).
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: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 110 |
Clinical Trials: | 6 |
Patent Applications: | 5,095 |
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 |
Ascension Genesys Hospital | 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 | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
XOPENEX | Inhalation Solution | levalbuterol hydrochloride | 0.25% | 020837 | 1 | 2006-05-23 |
XOPENEX | Inhalation Solution | levalbuterol hydrochloride | 0.0103%, 0.021% and 0.042% | 020837 | 1 | 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 a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-004 | Jul 18, 2003 | AN | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | AN | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | AN | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Lupin | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Lupin | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Akorn | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for XOPENEX
See the table below for patents covering XOPENEX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1071474 | ⤷ Try a Trial | |
Canada | 2073181 | R(-) ALBUTEROL OPTIQUEMENT PUR POUR LE TRAITEMENT DE L'ASTHME (OPTICALLY PURE R(-) ALBUTEROL FOR TREATING ASTHMA) | ⤷ Try a Trial |
Finland | 932540 | ⤷ Try a Trial | |
Greece | 3020133 | ⤷ Try a Trial | |
European Patent Office | 0509036 | ALBUTEROL R(-) OPTIQUEMENT PUR DE TRAITEMENT DE L'ASTHME (OPTICALLY PURE R(-) ALBUTEROL FOR TREATING ASTHMA) | ⤷ Try a Trial |
Japan | H05503102 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |