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RAZADYNE Drug Profile

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Razadyne is a drug marketed by Janssen Pharms and is included in three NDAs. It is available from five suppliers. There are three patents protecting this drug and three Paragraph IV challenges.

This drug has forty-two patent family members in thirty-three countries.

The generic ingredient in RAZADYNE is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the galantamine hydrobromide profile page.

Summary for Tradename: RAZADYNE

Patents:3
Applicants:1
NDAs:3
Suppliers / Packagers: see list5
Drug Prices: :see details

Pharmacology for Tradename: RAZADYNE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
RAZADYNE
galantamine hydrobromide
SOLUTION;ORAL021224-001Jun 22, 2001DISCNNo► subscribe► subscribe
Janssen Pharms
RAZADYNE
galantamine hydrobromide
TABLET;ORAL021169-003Feb 28, 2001RXNo6,099,863► subscribe ► subscribe
Janssen Pharms
RAZADYNE
galantamine hydrobromide
TABLET;ORAL021169-002Feb 28, 2001RXNo6,358,527► subscribeY ► subscribe
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Expired Patents for Tradename: RAZADYNE

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
RAZADYNE
galantamine hydrobromide
SOLUTION;ORAL021224-001Jun 22, 20014,663,318► subscribe
Janssen Pharms
RAZADYNE
galantamine hydrobromide
TABLET;ORAL021169-002Feb 28, 20014,663,318► subscribe
Janssen Pharms
RAZADYNE
galantamine hydrobromide
TABLET;ORAL021169-003Feb 28, 20014,663,318► subscribe
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Paragraph IV activity for: RAZADYNE

Drugname Dosage Strength RLD Submissiondate
galantamine hydrobromide Extended-release Capsules16 mg and 24 mgRazadyne ER3/11/2006
galantamine hydrobromide Extended-release Capsules8 mg Razadyne ER3/2/2006
galantamine hydrobromide Tablets4 mg, 8 mg and 12 mgRazadyne2/28/2005

International Patent Family for Tradename: RAZADYNE

Country Document Number Estimated Expiration
South Korea20000015851► subscribe
Poland330431► subscribe
Turkey9802592► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: RAZADYNE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00140Netherlands► subscribePRODUCT NAME: GALANTAMINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER GALANTAMINE HYDROBROMIDE; NAT. REGISTRATION NO/DATE: RVG 29073 - RVG 29076 20030702; FIRST REGISTRATION: SE 15561 - 15565 20000225
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