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Medtronic
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McKinsey
Colorcon
Covington
Accenture
Daiichi Sankyo
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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022252

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NDA 022252 describes NATAZIA, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NATAZIA profile page.

The generic ingredient in NATAZIA is dienogest; estradiol valerate. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dienogest; estradiol valerate profile page.
Summary for 022252
Tradename:NATAZIA
Applicant:Bayer Hlthcare
Ingredient:dienogest; estradiol valerate
Patents:2
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022252
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252 NDA AUTHORIZED GENERIC Sandoz Inc 0781-4110 N 0781-4110-15
NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-409 N 50419-409-00

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A
Approval Date:May 6, 2010TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:May 13, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY
Patent:➤ Sign UpPatent Expiration:Jan 30, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HEAVY MENSTRUAL BLEEDING IN WOMEN WITHOUT ORGANIC PATHOLOGY WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION

Expired US Patents for NDA 022252

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Chinese Patent Office
Deloitte
Fuji
Mallinckrodt
McKinsey
Queensland Health
Cipla
Dow

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