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RAZADYNE ER Drug Profile

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Razadyne Er 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.

This drug has forty-one patent family members in thirty-five countries.

The generic ingredient in RAZADYNE ER 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 ER

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: RAZADYNE ER

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
RAZADYNE ER
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL021615-001Apr 1, 2005RXYes7,160,559► subscribeY ► subscribe
Janssen Pharms
RAZADYNE ER
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL021615-002Apr 1, 2005RXNo7,160,559► subscribeY ► subscribe
Janssen Pharms
RAZADYNE ER
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL021615-003Apr 1, 2005RXNo7,160,559► subscribeY ► subscribe
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Expired Patents for Tradename: RAZADYNE ER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
RAZADYNE ER
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL021615-001Apr 1, 20054,663,318► subscribe
Janssen Pharms
RAZADYNE ER
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL021615-003Apr 1, 20054,663,318► subscribe
Janssen Pharms
RAZADYNE ER
galantamine hydrobromide
CAPSULE, EXTENDED RELEASE;ORAL021615-002Apr 1, 20054,663,318► subscribe
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Paragraph IV activity for: RAZADYNE ER

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

International Patent Family for Tradename: RAZADYNE ER

Country Document Number Estimated Expiration
Hungary0104778► subscribe
Czech Republic20012182► subscribe
Argentina022008► 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 ER

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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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.

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