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Serving leading biopharmaceutical companies globally:

Queensland Health
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Generated: December 15, 2017

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 four 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:1
Applicant:1
Ingredient:1
Patents:4
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 0781-4110-15 3 BLISTER PACK in 1 PACKAGE (0781-4110-15) > 1 KIT in 1 BLISTER PACK (0781-4110-52)
NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-409 50419-409-00 90 BLISTER PACK in 1 PACKAGE (50419-409-00) > 1 KIT in 1 BLISTER PACK

Summary 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:► SubscribePatent Expiration:Oct 25, 2016Product Flag?YSubstance Flag?Delist Request?Y
Patented Use:CONTRACEPTION
Patent:► SubscribePatent Expiration:Oct 25, 2016Product Flag?YSubstance Flag?Delist Request?Y
Patented Use:PREVENTION OF PREGNANCY
Patent:► SubscribePatent Expiration:Oct 25, 2016Product Flag?YSubstance Flag?Delist Request?Y
Patented Use:PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF CONTRACEPTION

Expired Orange Book Patents for NDA: 022252

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer HlthcareNATAZIAdienogest; estradiol valerateTABLET;ORAL022252-001May 6, 2010► Subscribe► Subscribe
Bayer HlthcareNATAZIAdienogest; estradiol valerateTABLET;ORAL022252-001May 6, 2010► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Federal Trade Commission
Moodys
Novartis
Cantor Fitzgerald
Queensland Health
Medtronic
Accenture
Chinese Patent Office
Argus Health

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.

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