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McKesson
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Medtronic
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Generated: December 16, 2017

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:1
Applicant:1
Ingredient:1
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 0078-0370-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0370-05)
RITALIN LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021284 NDA Novartis Pharmaceuticals Corporation 0078-0371 0078-0371-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0371-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Jun 5, 2002TE:AB1RLD:Yes
Patent:► SubscribePatent 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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Jun 5, 2002TE:AB1RLD:Yes
Patent:► SubscribePatent 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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength40MG
Approval Date:Jun 5, 2002TE:AB1RLD:Yes
Patent:► SubscribePatent 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 Orange Book Patents for NDA: 021284

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
NovartisRITALIN LAmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021284-002Jun 5, 2002► Subscribe► Subscribe
NovartisRITALIN LAmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021284-003Jun 5, 2002► Subscribe► Subscribe
NovartisRITALIN LAmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021284-004Apr 10, 2004► Subscribe► Subscribe
NovartisRITALIN LAmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021284-002Jun 5, 2002► Subscribe► Subscribe
NovartisRITALIN LAmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021284-002Jun 5, 2002► Subscribe► Subscribe
NovartisRITALIN LAmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021284-001Jun 5, 2002► Subscribe► Subscribe
NovartisRITALIN LAmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021284-001Jun 5, 2002► Subscribe► Subscribe
NovartisRITALIN LAmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021284-003Jun 5, 2002► Subscribe► Subscribe
NovartisRITALIN LAmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021284-001Jun 5, 2002► Subscribe► Subscribe
NovartisRITALIN LAmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021284-003Jun 5, 2002► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

McKesson
Teva
Medtronic
McKinsey
Chinese Patent Office
Federal Trade Commission
Covington
Express Scripts
US Army
Julphar

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