Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Queensland Health
Teva
Dow
Daiichi Sankyo
Cipla
Chinese Patent Office
McKesson
Covington

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020830

« Back to Dashboard

NDA 020830 describes SINGULAIR, which is a drug marketed by Merck and Msd Merck Co and is included in three NDAs. It is available from two suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the SINGULAIR profile page.

The generic ingredient in SINGULAIR is montelukast sodium. There are thirty-four drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for 020830
Tradename:SINGULAIR
Applicant:Msd Merck Co
Ingredient:montelukast sodium
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020830
Suppliers and Packaging for NDA: 020830
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830 NDA Merck Sharp & Dohme Corp. 0006-1711 N 0006-1711-31
SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830 NDA Merck Sharp & Dohme Corp. 0006-9275 N 0006-9275-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 5MG BASE
Approval Date:Feb 20, 1998TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 4MG BASE
Approval Date:Mar 3, 2000TE:ABRLD:Yes

Expired US Patents for NDA 020830

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-001 Feb 20, 1998 ➤ Sign Up ➤ Sign Up
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Teva
Daiichi Sankyo
Argus Health
Merck
Cerilliant
Express Scripts
Citi
US Department of Justice

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.