XOPENEX Drug Patent Profile

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Which patents cover Xopenex, and what generic alternatives are available?

Xopenex is a drug marketed by Hikma and Lupin and is included in two NDAs. There is one patent 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

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

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Summary for XOPENEX

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	6
Patent Applications:	4,719
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

Drug patent expirations by year for XOPENEX

Recent Clinical Trials for XOPENEX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Henry Ford Health System	Phase 4
Ascension Genesys Hospital	Phase 4
Fahim Khorfan, MD	Phase 4

See all XOPENEX clinical trials

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

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Glossary

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

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

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Country	Patent Number	Title	Estimated Expiration
Spain	2088152		⤷ Sign Up
World Intellectual Property Organization (WIPO)	9109596		⤷ Sign Up
Germany	69118359		⤷ Sign Up
Canada	2073181	R(-) ALBUTEROL OPTIQUEMENT PUR POUR LE TRAITEMENT DE L'ASTHME (OPTICALLY PURE R(-) ALBUTEROL FOR TREATING ASTHMA)	⤷ Sign Up
Japan	H06503841		⤷ Sign Up
Mexico	9205639	COMPOSICIONES Y TEJIDOS DE POLIMEROS TRATADOS CON LAS MISMAS.	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration