Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
Boehringer Ingelheim
Merck
Mallinckrodt
Colorcon

Last Updated: October 24, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021615

See Plans and Pricing

« Back to Dashboard

NDA 021615 describes RAZADYNE ER, which is a drug marketed by Janssen Pharms 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 RAZADYNE ER profile page.

The generic ingredient in RAZADYNE ER is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
Summary for 021615
Tradename:RAZADYNE ER
Applicant:Janssen Pharms
Ingredient:galantamine hydrobromide
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021615
Mechanism of ActionCholinesterase Inhibitors
Medical Subject Heading (MeSH) Categories for 021615
Suppliers and Packaging for NDA: 021615
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615 NDA Patriot Pharmaceuticals, LLC 10147-0891 10147-0891-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10147-0891-3)
RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615 NDA Patriot Pharmaceuticals, LLC 10147-0892 10147-0892-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10147-0892-3)
Paragraph IV (Patent) Challenges for 021615
Tradename Dosage Ingredient NDA Submissiondate
RAZADYNE ER CAPSULE, EXTENDED RELEASE;ORAL galantamine hydrobromide 021615 2006-03-11
RAZADYNE ER CAPSULE, EXTENDED RELEASE;ORAL galantamine hydrobromide 021615 2006-03-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 8MG BASE
Approval Date:Apr 1, 2005TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Dec 20, 2019Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 16MG BASE
Approval Date:Apr 1, 2005TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Dec 20, 2019Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 24MG BASE
Approval Date:Apr 1, 2005TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Dec 20, 2019Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021615

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-001 Apr 1, 2005   Start Trial   Start Trial
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-003 Apr 1, 2005   Start Trial   Start Trial
Janssen Pharms RAZADYNE ER galantamine hydrobromide CAPSULE, EXTENDED RELEASE;ORAL 021615-002 Apr 1, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Dow
AstraZeneca
Merck
Boehringer Ingelheim
McKesson

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.