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Serving leading biopharmaceutical companies globally:

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Baxter
Fish and Richardson
Federal Trade Commission
Fuji
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Generated: December 13, 2017

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Levalbuterol hydrochloride - Generic Drug Details

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What are the generic sources for levalbuterol hydrochloride and what is the scope of levalbuterol hydrochloride patent protection?

Levalbuterol hydrochloride
is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Cipla Ltd, Impax Labs Inc, Mylan Speciality Lp, Ritedose Corp, Teva Parenteral, Teva Pharms Usa, and Oak Pharms Inc, and is included in ten NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for levalbuterol hydrochloride. Fourteen suppliers are listed for this compound.

Summary for levalbuterol hydrochloride

Pharmacology for levalbuterol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Teva Pharms UsaLEVALBUTEROL HYDROCHLORIDElevalbuterol hydrochlorideSOLUTION;INHALATION090297-001Apr 26, 2013ANRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Oak Pharms IncXOPENEXlevalbuterol hydrochlorideSOLUTION;INHALATION020837-004Jul 18, 2003ANRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Cipla LtdLEVALBUTEROL HYDROCHLORIDElevalbuterol hydrochlorideSOLUTION;INHALATION078171-001Dec 13, 2013ANRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Oak Pharms IncXOPENEXlevalbuterol hydrochlorideSOLUTION;INHALATION020837-004Jul 18, 2003ANRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Cipla LtdLEVALBUTEROL HYDROCHLORIDElevalbuterol hydrochlorideSOLUTION;INHALATION078171-002Dec 13, 2013ANRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Speciality LpLEVALBUTEROL HYDROCHLORIDElevalbuterol hydrochlorideSOLUTION;INHALATION077800-002Mar 15, 2013ANRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Speciality LpLEVALBUTEROL HYDROCHLORIDElevalbuterol hydrochlorideSOLUTION;INHALATION077800-003Mar 15, 2013ANRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Ritedose CorpLEVALBUTEROL HYDROCHLORIDElevalbuterol hydrochlorideSOLUTION;INHALATION203653-001Mar 22, 2016ANRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva Pharms UsaLEVALBUTEROL HYDROCHLORIDElevalbuterol hydrochlorideSOLUTION;INHALATION090297-003Apr 26, 2013ANRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Cipla LtdLEVALBUTEROL HYDROCHLORIDElevalbuterol hydrochlorideSOLUTION;INHALATION078171-003Dec 13, 2013ANRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: levalbuterol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Oak Pharms IncXOPENEXlevalbuterol hydrochlorideSOLUTION;INHALATION020837-004Jul 18, 2003► Subscribe► Subscribe
Oak Pharms IncXOPENEXlevalbuterol hydrochlorideSOLUTION;INHALATION020837-004Jul 18, 2003► Subscribe► Subscribe
Oak Pharms IncXOPENEXlevalbuterol hydrochlorideSOLUTION;INHALATION020837-001Mar 25, 1999► Subscribe► Subscribe
Oak Pharms IncXOPENEXlevalbuterol hydrochlorideSOLUTION;INHALATION020837-004Jul 18, 2003► Subscribe► Subscribe
Oak Pharms IncXOPENEXlevalbuterol hydrochlorideSOLUTION;INHALATION020837-004Jul 18, 2003► Subscribe► Subscribe
Oak Pharms IncXOPENEXlevalbuterol hydrochlorideSOLUTION;INHALATION020837-001Mar 25, 1999► Subscribe► Subscribe
Oak Pharms IncXOPENEXlevalbuterol hydrochlorideSOLUTION;INHALATION020837-003Jan 30, 2002► Subscribe► Subscribe
Oak Pharms IncXOPENEXlevalbuterol hydrochlorideSOLUTION;INHALATION020837-004Jul 18, 2003► Subscribe► Subscribe
Oak Pharms IncXOPENEXlevalbuterol hydrochlorideSOLUTION;INHALATION020837-002Mar 25, 1999► Subscribe► Subscribe
Oak Pharms IncXOPENEXlevalbuterol hydrochlorideSOLUTION;INHALATION020837-002Mar 25, 1999► Subscribe► Subscribe
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Argus Health
Fuji
Teva
Covington
Federal Trade Commission
Baxter
Deloitte
Johnson and Johnson
Mallinckrodt

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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