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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021284

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NDA 021284 describes RITALIN LA, which is a drug marketed by Novartis and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the RITALIN LA profile page.

The generic ingredient in RITALIN LA 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 021284
Tradename:RITALIN LA
Applicant:Novartis
Ingredient:methylphenidate hydrochloride
Patents:1
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021284
Suppliers and Packaging for NDA: 021284
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284 NDA Novartis Pharmaceuticals Corporation 0078-0370 N 0078-0370-05
RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284 NDA Novartis Pharmaceuticals Corporation 0078-0371 N 0078-0371-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Jun 5, 2002TE:AB1RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING METHYLPHENIDATE BI-MODAL RELEASE PROFILE EXTENDED-RELEASE CAPSULES

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Jun 5, 2002TE:AB1RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING METHYLPHENIDATE BI-MODAL RELEASE PROFILE EXTENDED-RELEASE CAPSULES

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength40MG
Approval Date:Jun 5, 2002TE:AB1RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING METHYLPHENIDATE BI-MODAL RELEASE PROFILE EXTENDED-RELEASE CAPSULES

Expired US Patents for NDA 021284

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-002 Jun 5, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-004 Apr 10, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-004 Apr 10, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284-001 Jun 5, 2002 ➤ 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
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Healthtrust
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