Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
McKinsey
Medtronic
McKesson
Dow

Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021149

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

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
Tradename:OVIDREL
Applicant:Emd Serono
Ingredient:choriogonadotropin alfa
Patents:1
Generic Entry Opportunity Date for 021149
Generic Entry Date for 021149*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;SUBCUTANEOUS

*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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Moodys
Merck
McKinsey
Boehringer Ingelheim

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.