Levalbuterol tartrate - Generic Drug Details

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What are the generic sources for levalbuterol tartrate and what is the scope of freedom to operate?

Levalbuterol tartrate is the generic ingredient in one branded drug marketed by Lupin and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Levalbuterol tartrate has thirty-six patent family members in eighteen countries.

Four suppliers are listed for this compound.

Summary for levalbuterol tartrate

International Patents:	36
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Clinical Trials:	5
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for levalbuterol tartrate
What excipients (inactive ingredients) are in levalbuterol tartrate?	levalbuterol tartrate excipients list
DailyMed Link:	levalbuterol tartrate at DailyMed

Recent Clinical Trials for levalbuterol tartrate

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

Sponsor	Phase
Sunovion	Phase 2
Sunovion	Phase 3

See all levalbuterol tartrate clinical trials

Pharmacology for levalbuterol tartrate

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

Paragraph IV (Patent) Challenges for LEVALBUTEROL TARTRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XOPENEX HFA	Inhalation Aerosol	levalbuterol tartrate	0.045 mg/actuation	021730	1	2012-02-27

US Patents and Regulatory Information for levalbuterol tartrate

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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
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 levalbuterol tartrate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	⤷ Sign Up	⤷ Sign Up
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	⤷ Sign Up	⤷ Sign Up
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	⤷ Sign Up	⤷ Sign Up
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for levalbuterol tartrate

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Country	Patent Number	Title	Estimated Expiration
Germany	60336089		⤷ Sign Up
Portugal	1671942		⤷ Sign Up
Portugal	1572622		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004052835		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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