Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Express Scripts
Dow
McKesson
Harvard Business School

Last Updated: November 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020830

See Plans and Pricing

« 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-five drug master file entries for this compound. Forty-six 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
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 0006-1711-31 30 TABLET, CHEWABLE in 1 BOTTLE (0006-1711-31)
SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830 NDA Merck Sharp & Dohme Corp. 0006-9275 0006-9275-31 30 TABLET, CHEWABLE in 1 BOTTLE (0006-9275-31)
Paragraph IV (Patent) Challenges for 020830
Tradename Dosage Ingredient NDA Submissiondate
SINGULAIR TABLET, CHEWABLE;ORAL montelukast sodium 020830 2006-12-26

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   Start Trial   Start Trial
Msd Merck Co SINGULAIR montelukast sodium TABLET, CHEWABLE;ORAL 020830-002 Mar 3, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Medtronic
Colorcon
Express Scripts
McKesson

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.