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Covington
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Deloitte
Boehringer Ingelheim
Cipla
Farmers Insurance

Generated: July 18, 2018

DrugPatentWatch Database Preview

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 five 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-one drug master file entries for this compound. Two suppliers are 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:5
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021514
Generic Entry Date for 021514*:
Constraining patent/regulatory exclusivity:
Dosage::
FILM, EXTENDED RELEASE;TRANSDERMAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 N 68968-5552-3
DAYTRANA methylphenidate FILM, EXTENDED RELEASE;TRANSDERMAL 021514 NDA Noven Therapeutics, LLC 68968-5553 N 68968-5553-3

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:➤ Try a Free TrialPatent Expiration:Sep 30, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Patent:➤ Try a Free TrialPatent Expiration:Sep 30, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Patent:➤ Try a Free TrialPatent Expiration:Oct 7, 2025Product Flag?YSubstance Flag?Delist Request?

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

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo
McKesson
Colorcon
Covington
Cantor Fitzgerald
Baxter
Fish and Richardson
Julphar

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