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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
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Dow
Harvard Business School
Express Scripts
QuintilesIMS
Julphar
Queensland Health
AstraZeneca

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021121

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NDA 021121 describes CONCERTA, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from five suppliers. There are five patents protecting this drug and two Paragraph IV challenges. Additional details are available on the CONCERTA profile page.

The generic ingredient in CONCERTA is methylphenidate hydrochloride. There are thirty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 021121
Tradename:CONCERTA
Applicant:Janssen Pharms
Ingredient:methylphenidate hydrochloride
Patents:5
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021121
Suppliers and Packaging for NDA: 021121
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-2715 N 0591-2715-01
CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-2715 N 0591-2715-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength18MG
Approval Date:Aug 1, 2000TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 31, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jan 31, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jan 31, 2018Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 021121

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-004 Apr 1, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-004 Apr 1, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 ➤ 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:

Argus Health
Queensland Health
Fuji
Boehringer Ingelheim
Medtronic
Citi
Express Scripts
Julphar
Harvard Business School

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