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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
UBS
Harvard Business School
Federal Trade Commission
Colorcon
Express Scripts
Baxter
Novartis
Johnson and Johnson

Generated: July 27, 2017

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 NDA: 021514

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:5
Formulation / Manufacturing:see details

Pharmacology for NDA: 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

Summary 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:► SubscribePatent Expiration:Oct 7, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Oct 7, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Oct 7, 2025Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021514

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-002Apr 6, 2006► Subscribe► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-003Apr 6, 2006► Subscribe► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-001Apr 6, 2006► Subscribe► Subscribe
Noven Pharms Inc
DAYTRANA
methylphenidate
FILM, EXTENDED RELEASE;TRANSDERMAL021514-004Apr 6, 2006► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

McKinsey
Colorcon
Novartis
Harvard Business School
Chubb
Baxter
Accenture
Medtronic
US Department of Justice
Cantor Fitzgerald

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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