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Last Updated: July 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021098


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NDA 021098 describes YASMIN, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the YASMIN profile page.

The generic ingredient in YASMIN is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
Summary for 021098
Tradename:YASMIN
Applicant:Bayer Hlthcare
Ingredient:drospirenone; ethinyl estradiol
Patents:1
Suppliers and Packaging for NDA: 021098
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098 NDA AUTHORIZED GENERIC TEVA PHARMACEUTICALS USA, INC. 0555-9131 0555-9131-67 3 BLISTER PACK in 1 PACKAGE (0555-9131-67) > 1 KIT in 1 BLISTER PACK (0555-9131-79)
YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-402 50419-402-03 3 BLISTER PACK in 1 PACKAGE (50419-402-03) > 1 KIT in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 021098
Tradename Dosage Ingredient NDA Submissiondate
YASMIN TABLET;ORAL-28 drospirenone; ethinyl estradiol 021098 2005-01-07

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength3MG;0.03MG
Approval Date:May 11, 2001TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Aug 31, 2020Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021098

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001   Start Trial   Start Trial
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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