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.
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022252
*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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A | ||||
| Approval Date: | May 6, 2010 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 13, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | PREVENTION OF PREGNANCY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 30, 2028 | Product 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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