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CETRORELIX - Generic Drug Details

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Cetrorelix is the generic ingredient in one branded drug marketed by Emd Serono Inc and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-five patent family members in twenty-two countries.

There is one drug master file entry for cetrorelix. One supplier is listed for this compound.

Summary for Generic Name: CETRORELIX

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: see list1
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details

Clinical Trials for: CETRORELIX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Emd Serono Inc
CETROTIDE
cetrorelix
INJECTABLE;INJECTION021197-001Aug 11, 2000RXYes6,319,192<disabled> <disabled>
Emd Serono Inc
CETROTIDE
cetrorelix
INJECTABLE;INJECTION021197-002Aug 11, 2000DISCNNo6,319,192<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: cetrorelix

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono Inc
CETROTIDE
cetrorelix
INJECTABLE;INJECTION021197-002Aug 11, 20007,605,121<disabled>
Emd Serono Inc
CETROTIDE
cetrorelix
INJECTABLE;INJECTION021197-001Aug 11, 20004,800,191<disabled>
Emd Serono Inc
CETROTIDE
cetrorelix
INJECTABLE;INJECTION021197-002Aug 11, 20004,800,191<disabled>
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International Patent Family for Ingredient: cetrorelix

Country Document Number Estimated Expiration
Brazil9909802<disabled in preview>
Australia3702899<disabled in preview>
Norway20005145<disabled in preview>
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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: CETRORELIX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90029Netherlands<disabled>PRODUCT NAME: CETRORELIX, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZUUR ADDITIEZOUT, IN HET BIJZONDER CETRORELIX ACETAAT; REGISTRATION NO/DATE: EU/1/99/100/001-003 19990413
/1999Austria<disabled>PRODUCT NAME: CETRORELIX UND PHARMAZEUTISCH ANNEHMBARE SAEUREADDITIONSSALZE DAVON, INSBESONDERE CETRORELIXACETAT; REGISTRATION NO/DATE: EU/1/99/100/001- EU/1/99/100/003 19990413
9C0031Belgium<disabled>PRODUCT NAME: ACETATE DE CETRORELIX; REGISTRATION NO/DATE: EU/1/99/100/001 19990413
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