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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021676

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NDA 021676 describes YAZ, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the YAZ profile page.

The generic ingredient in YAZ is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
Summary for 021676
Tradename:YAZ
Applicant:Bayer Hlthcare
Ingredient:drospirenone; ethinyl estradiol
Patents:3
Suppliers and Packaging for NDA: 021676
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA Inc 0093-5423 0093-5423-58 3 BLISTER PACK in 1 PACKAGE (0093-5423-58) > 1 KIT in 1 BLISTER PACK (0093-5423-28)
YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA Inc 0093-5423 0093-5423-62 3 BLISTER PACK in 1 PACKAGE (0093-5423-62) > 1 KIT in 1 BLISTER PACK (0093-5423-28)
Paragraph IV (Patent) Challenges for 021676
Tradename Dosage Ingredient NDA Submissiondate
YAZ TABLET;ORAL drospirenone; ethinyl estradiol 021676 2006-09-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG;0.02MG
Approval Date:Mar 16, 2006TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Aug 31, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Dec 20, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Dec 20, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY

Expired US Patents for NDA 021676

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006   Start Trial   Start Trial
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006   Start Trial   Start Trial
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006   Start Trial   Start Trial
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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