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Generated: November 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021197

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NDA 021197 describes CETROTIDE, which is a drug marketed by Emd Serono Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the CETROTIDE profile page.

The generic ingredient in CETROTIDE is cetrorelix. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cetrorelix profile page.
Summary for 021197
Tradename:CETROTIDE
Applicant:Emd Serono Inc
Ingredient:cetrorelix
Patents:1
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021197
Generic Entry Date for 021197*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;INJECTION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 021197
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETROTIDE cetrorelix INJECTABLE;INJECTION 021197 NDA EMD Serono, Inc. 44087-1225 44087-1225-1 1 KIT in 1 CARTON (44087-1225-1) * 1 mL in 1 SYRINGE, GLASS * 1 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.25MG BASE/ML
Approval Date:Aug 11, 2000TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 23, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREMATURE LH SURGES IN WOMEN UNDERGOING CONTROLLED OVARIAN STIMULATION

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 3MG BASE/ML
Approval Date:Aug 11, 2000TE:RLD:No
Patent:➤ Try a Free TrialPatent Expiration:Apr 23, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREMATURE LH SURGES IN WOMEN UNDERGOING CONTROLLED OVARIAN STIMULATION

Expired US Patents for NDA 021197

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono Inc CETROTIDE cetrorelix INJECTABLE;INJECTION 021197-002 Aug 11, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono Inc CETROTIDE cetrorelix INJECTABLE;INJECTION 021197-001 Aug 11, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono Inc CETROTIDE cetrorelix INJECTABLE;INJECTION 021197-001 Aug 11, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono Inc CETROTIDE cetrorelix INJECTABLE;INJECTION 021197-002 Aug 11, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono Inc CETROTIDE cetrorelix INJECTABLE;INJECTION 021197-001 Aug 11, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Emd Serono Inc CETROTIDE cetrorelix INJECTABLE;INJECTION 021197-002 Aug 11, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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