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Serving 500+ biopharmaceutical companies globally:

Baxter
AstraZeneca
Julphar
Accenture
Chinese Patent Office
UBS
Boehringer Ingelheim
QuintilesIMS
Covington
Novartis

Generated: September 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020837

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NDA 020837 describes XOPENEX, which is a drug marketed by Oak Pharms Inc and Sunovion and is included in two NDAs. It is available from six suppliers. There are three patents protecting this drug and three Paragraph IV challenges. Additional details are available on the XOPENEX profile page.

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 NDA: 020837

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Respiratory Tract Agents

Pharmacology for NDA: 020837

Mechanism of ActionAdrenergic beta2-Agonists

Suppliers and Packaging for NDA: 020837

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION 020837 NDA Akorn, Inc. 17478-171 17478-171-30 30 POUCH in 1 CARTON (17478-171-30) > 1 VIAL, SINGLE-DOSE in 1 POUCH (17478-171-01) > .5 mL in 1 VIAL, SINGLE-DOSE
XOPENEX
levalbuterol hydrochloride
SOLUTION;INHALATION 020837 NDA Akorn, Inc. 17478-172 17478-172-24 2 POUCH in 1 CARTON (17478-172-24) > 12 VIAL, SINGLE-DOSE in 1 POUCH (17478-172-12) > 3 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Mar 25, 1999TE:ANRLD:Yes
Regulatory Exclusivity Expiration:Jan 22, 2018
Regulatory Exclusivity Use:REVISIONS TO THE LABELING BASED ON THE OUTCOMES OF PEDIATRIC STUDIES CONDUCTED TO ASSESS THE SAFETY AND EFFICACY OF XOPENEX IN SUBJECTS LESS THAN 6 YEARS OF AGE
Patent:► SubscribePatent Expiration:Mar 21, 2021Product Flag?Substance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.042% BASE
Approval Date:Mar 25, 1999TE:ANRLD:Yes
Regulatory Exclusivity Expiration:Jan 22, 2018
Regulatory Exclusivity Use:REVISIONS TO THE LABELING BASED ON THE OUTCOMES OF PEDIATRIC STUDIES CONDUCTED TO ASSESS THE SAFETY AND EFFICACY OF XOPENEX IN SUBJECTS LESS THAN 6 YEARS OF AGE

Expired Orange Book Patents for NDA: 020837



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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Merck
US Department of Justice
Mallinckrodt
McKesson
Express Scripts
Federal Trade Commission
Baxter
Cantor Fitzgerald
Novartis

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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