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Last Updated: April 2, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021149

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NDA 021149 describes OVIDREL, which is a drug marketed by Emd Serono 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 OVIDREL profile page.

The generic ingredient in OVIDREL is choriogonadotropin alfa. One supplier is listed for this compound. Additional details are available on the choriogonadotropin alfa profile page.
Summary for 021149
Applicant:Emd Serono
Ingredient:choriogonadotropin alfa
Generic Entry Opportunity Date for 021149
Generic Entry Date for 021149*:
Constraining patent/regulatory exclusivity:

*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.

Pharmacology for NDA: 021149
Suppliers and Packaging for NDA: 021149
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OVIDREL choriogonadotropin alfa INJECTABLE;INJECTION 021149 NDA EMD Serono, Inc. 44087-1150 44087-1150-1 1 SYRINGE, GLASS in 1 CARTON (44087-1150-1) > .5 mL in 1 SYRINGE, GLASS
OVIDREL choriogonadotropin alfa INJECTABLE;SUBCUTANEOUS 021149 NDA EMD Serono, Inc. 44087-1150 44087-1150-1 1 SYRINGE, GLASS in 1 CARTON (44087-1150-1) > .5 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.25MG/VIAL
Approval Date:Sep 20, 2000TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 0.25MG /0.5ML
Approval Date:Oct 6, 2003TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 16, 2021Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021149

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono OVIDREL choriogonadotropin alfa INJECTABLE;INJECTION 021149-001 Sep 20, 2000   Start Trial   Start Trial
Emd Serono OVIDREL choriogonadotropin alfa INJECTABLE;SUBCUTANEOUS 021149-002 Oct 6, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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