LEVALBUTEROL HYDROCHLORIDE - Generic Drug Details

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

Levalbuterol hydrochloride is the generic ingredient in two branded drugs marketed by Cipla, Impax Labs Inc, Luoxin Aurovitas, Mylan Speciality Lp, Norvium Bioscience, Ritedose Corp, Sun Pharm, Teva Parenteral, Teva Pharms Usa, and Hikma, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for levalbuterol hydrochloride. Eleven suppliers are listed for this compound.

Summary for LEVALBUTEROL HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	11
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	33
Patent Applications:	1,504
What excipients (inactive ingredients) are in LEVALBUTEROL HYDROCHLORIDE?	LEVALBUTEROL HYDROCHLORIDE excipients list
DailyMed Link:	LEVALBUTEROL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for LEVALBUTEROL HYDROCHLORIDE

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

Sponsor	Phase
University of Aleppo	Phase 4
Children's Hospital Los Angeles	N/A
University of Illinois at Chicago	N/A

See all LEVALBUTEROL HYDROCHLORIDE clinical trials

Pharmacology for LEVALBUTEROL HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for LEVALBUTEROL HYDROCHLORIDE

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 LEVALBUTEROL HYDROCHLORIDE

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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
Norvium Bioscience	LEVALBUTEROL HYDROCHLORIDE	levalbuterol hydrochloride	SOLUTION;INHALATION	077800-003	Mar 15, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ritedose Corp	LEVALBUTEROL HYDROCHLORIDE	levalbuterol hydrochloride	SOLUTION;INHALATION	203653-002	Mar 22, 2016	AN	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	LEVALBUTEROL HYDROCHLORIDE	levalbuterol hydrochloride	SOLUTION;INHALATION	090297-002	Apr 26, 2013	AN	RX	No	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

Expired US Patents for LEVALBUTEROL HYDROCHLORIDE

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

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