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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021278

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NDA 021278 describes FOCALIN, which is a drug marketed by Novartis and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug and eight Paragraph IV challenges. Additional details are available on the FOCALIN profile page.

The generic ingredient in FOCALIN is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
Summary for 021278
Tradename:FOCALIN
Applicant:Novartis
Ingredient:dexmethylphenidate hydrochloride
Patents:0
Pharmacology for NDA: 021278
Medical Subject Heading (MeSH) Categories for 021278
Suppliers and Packaging for NDA: 021278
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278 NDA Novartis Pharmaceuticals Corporation 0078-0380 0078-0380-05 100 TABLET in 1 BOTTLE (0078-0380-05)
FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278 NDA Novartis Pharmaceuticals Corporation 0078-0381 0078-0381-05 100 TABLET in 1 BOTTLE (0078-0381-05)
Paragraph IV (Patent) Challenges for 021278
Tradename Dosage Ingredient NDA Submissiondate
FOCALIN TABLET;ORAL dexmethylphenidate hydrochloride 021278 2004-07-27
FOCALIN TABLET;ORAL dexmethylphenidate hydrochloride 021278 2004-05-27

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Nov 13, 2001TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 13, 2001TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 13, 2001TE:ABRLD:Yes

Expired US Patents for NDA 021278

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-003 Nov 13, 2001   Start Trial   Start Trial
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-003 Nov 13, 2001   Start Trial   Start Trial
Novartis FOCALIN dexmethylphenidate hydrochloride TABLET;ORAL 021278-001 Nov 13, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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