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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Deloitte
Daiichi Sankyo
Colorcon
Argus Health
Julphar
Merck
Moodys
Chubb
Healthtrust

Generated: February 23, 2018

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 Oak Pharms Inc and Sunovion and is included in two NDAs. There are three patents protecting this drug and three Paragraph IV challenges.

The generic ingredient in XOPENEX is levalbuterol tartrate. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.
Summary for XOPENEX
Drug patent expirations by year for XOPENEX
Pharmacology for XOPENEX

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
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 AN RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 AN RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 AN RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 AN RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 AN RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 AN RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999 AN RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999 AN RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sunovion XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sunovion XOPENEX HFA levalbuterol tartrate AEROSOL, METERED;INHALATION 021730-001 Mar 11, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for XOPENEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-001 Mar 25, 1999 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-003 Jan 30, 2002 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-004 Jul 18, 2003 ➤ Sign Up ➤ Sign Up
Oak Pharms Inc XOPENEX levalbuterol hydrochloride SOLUTION;INHALATION 020837-002 Mar 25, 1999 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for XOPENEX
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Inhalation Aerosol 0.045 mg/actuation ➤ Subscribe 2/27/2012
➤ Subscribe Inhalation Solution 0.0025 ➤ Subscribe 5/23/2006
➤ Subscribe Inhalation Solution 0.0103%, 0.021% and 0.042% ➤ Subscribe 6/20/2005

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
UBS
Cipla
Citi
Covington
Chubb
AstraZeneca
Baxter
Cerilliant

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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