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Details for New Drug Application (NDA): 021204

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NDA 021204 describes STARLIX, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the STARLIX profile page.

The generic ingredient in STARLIX is nateglinide. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the nateglinide profile page.

Summary for NDA: 021204

Tradename:
STARLIX
Applicant:
Novartis
Ingredient:
nateglinide
Patents:4
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 021204

Mechanism of ActionPotassium Channel Antagonists

Suppliers and Packaging for NDA: 021204

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STARLIX
nateglinide
TABLET;ORAL 021204 NDA Novartis Pharmaceuticals Corporation 0078-0351 0078-0351-05 100 TABLET in 1 BOTTLE (0078-0351-05)
STARLIX
nateglinide
TABLET;ORAL 021204 NDA Novartis Pharmaceuticals Corporation 0078-0352 0078-0352-05 100 TABLET in 1 BOTTLE (0078-0352-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Dec 22, 2000TE:ABRLD:No
Patent:6,878,749Patent Expiration:Sep 15, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:6,641,841Patent Expiration:Nov 14, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE AS A BLOOD GLUCOSE-LOWERING AGENT
Patent:6,844,008Patent Expiration:Nov 14, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE AS A BLOOD GLUCOSE-LOWERING AGENT

Expired Orange Book Patents for NDA: 021204

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-002Dec 22, 20005,463,116► subscribe
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 20005,463,116► subscribe
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-002Dec 22, 20005,488,150► subscribe
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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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