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Last Updated: November 21, 2019

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Details for New Drug Application (NDA): 021514

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NDA 021514 describes DAYTRANA, which is a drug marketed by Noven Pharms Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DAYTRANA profile page.

The generic ingredient in DAYTRANA is methylphenidate. There are thirty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methylphenidate profile page.
Summary for 021514
Tradename:DAYTRANA
Applicant:Noven Pharms Inc
Ingredient:methylphenidate
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 021514
Medical Subject Heading (MeSH) Categories for 021514
Suppliers and Packaging for NDA: 021514
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514 NDA Noven Therapeutics, LLC 68968-5552 68968-5552-3 30 PATCH in 1 CARTON (68968-5552-3) > 9 h in 1 PATCH
DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514 NDA Noven Therapeutics, LLC 68968-5553 68968-5553-3 30 PATCH in 1 CARTON (68968-5553-3) > 9 h in 1 PATCH
Paragraph IV (Patent) Challenges for 021514
Tradename Dosage Ingredient NDA Submissiondate
DAYTRANA FILM, EXTENDED RELEASE;TRANSDERMAL methylphenidate 021514 2011-04-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength10MG/9HR (1.1MG/HR)
Approval Date:Apr 6, 2006TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 7, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Oct 7, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Oct 7, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR TRANSDERMALLY DELIVERING A DRUG TO A USER IN NEED THEREOF

Expired US Patents for NDA 021514

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-002 Apr 6, 2006   Start Trial   Start Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-001 Apr 6, 2006   Start Trial   Start Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-003 Apr 6, 2006   Start Trial   Start Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-003 Apr 6, 2006   Start Trial   Start Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-003 Apr 6, 2006   Start Trial   Start Trial
Noven Pharms Inc DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514-004 Apr 6, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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