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Generated: December 18, 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 three 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-two drug master file entries for this compound. Thirty-nine 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
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 0591-2715-01 100 TABLET in 1 BOTTLE (0591-2715-01)
CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-2715 0591-2715-30 30 TABLET in 1 BOTTLE (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:➤ Sign UpPatent Expiration:Jan 31, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jan 31, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent 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 021121-003 Dec 8, 2000 ➤ Sign Up ➤ Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000 ➤ Sign Up ➤ Sign Up
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Chinese Patent Office
Boehringer Ingelheim
Cipla
Fuji
Mallinckrodt
Argus Health
Johnson and Johnson
Daiichi Sankyo
Merck

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