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Last Updated: December 6, 2019

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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 two 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. Two 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
Generic Entry Opportunity Date for 022252
Generic Entry Date for 022252*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
Paragraph IV (Patent) Challenges for 022252
Tradename Dosage Ingredient NDA Submissiondate
NATAZIA TABLET;ORAL dienogest; estradiol valerate 022252 2010-10-22

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:  Start TrialPatent Expiration:May 13, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY
Patent:  Start TrialPatent 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   Start Trial   Start Trial
Bayer Hlthcare NATAZIA dienogest; estradiol valerate TABLET;ORAL 022252-001 May 6, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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