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GANIRELIX ACETATE Drug Profile

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Ganirelix Acetate is a drug marketed by Organon Usa Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has six patent family members in seven countries.

The generic ingredient in GANIRELIX ACETATE is ganirelix acetate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ganirelix acetate profile page.

Summary for Tradename: GANIRELIX ACETATE

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: GANIRELIX ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon Usa Inc
GANIRELIX ACETATE
ganirelix acetate
INJECTABLE;INJECTION021057-001Jul 29, 1999RXYes6,653,286► subscribe ► subscribe
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Expired Patents for Tradename: GANIRELIX ACETATE

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc
GANIRELIX ACETATE
ganirelix acetate
INJECTABLE;INJECTION021057-001Jul 29, 19994,801,577► subscribe
Organon Usa Inc
GANIRELIX ACETATE
ganirelix acetate
INJECTABLE;INJECTION021057-001Jul 29, 19995,767,082► subscribe
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Paragraph IV activity for: GANIRELIX ACETATE

Drugname Dosage Strength RLD Submissiondate
ganirelix acetateInjection250 mcg/0.5 mL, 1 mL PFSGanirelix Acetate3/30/2012

International Patent Family for Tradename: GANIRELIX ACETATE

Country Document Number Estimated Expiration
Austria302018► subscribe
European Patent Office0994718► subscribe
Australia8727798► 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: GANIRELIX ACETATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00C/030Belgium► subscribePRODUCT NAME: GANIRELIX; REGISTRATION NO/DATE: EU/1/00/130/001 20000518
00016Netherlands► subscribePRODUCT NAME: GANIRELIX, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION NO/DATE: EU/1/00/130/001-002 20000517
C/GB00/024United Kingdom► subscribePRODUCT NAME: GANIRELIX OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/130/001 20000517; UK EU/1/00/130/002 20000517
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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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