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Generated: May 22, 2018

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 four 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 ten 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
Formulation / Manufacturing:	see details

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	N	0093-5423-58
YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA Inc	0093-5423	N	0093-5423-62

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	3MG;0.02MG
Approval Date:	Mar 16, 2006	TE:	AB	RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Aug 31, 2020	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	➤ Sign Up	Patent Expiration:	Dec 20, 2021	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	➤ Sign Up	Patent Expiration:	Dec 20, 2021	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	PREVENTION OF PREGNANCY

Expired US Patents for NDA 021676

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

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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.