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Details for Patent: 8,153,616

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Patent 8,153,616 protects NATAZIA and is included in one NDA. There has been one Paragraph IV challenge on Natazia.

This patent has thirty-two patent family members in twenty countries.

Summary for Patent: 8,153,616

Title:Combination preparation for oral contraception and oral therapy of dysfunctional uterine bleeding containing estradiol valerate and dienogest and method of using same
Abstract: The multiphase combination preparation for oral therapy of dysfunctional uterine bleeding and for oral contraception contains a first phase consisting of 2 daily dosage units, each containing 3 mg of estradiol valerate or <3 mg of estradiol; a second phase consisting of a first group of 5 daily dosage units, each consisting of a combination of 2 mg of dienogest with 2 mg of estradiol valerate or <2 mg of estradiol, and a second group consisting of 17 daily dosage units, each consisting of a combination of 3 mg of dienogest with 2 mg of estradiol valerate or <2 mg of estradiol; a third phase consisting of 2 daily dosage units, each containing 1 mg of estradiol valerate or <1 mg of estradiol; and another phase consisting of 2 daily dosage units of a pharmaceutically harmless placebos.
Inventor(s): Zeun; Susan (Berlin, DE), Boudes; Pol (Hackettstown, NJ), Secci; Angelo (Parsipanny, NJ), Nedrikat; Jan (Chianti Kirkland, CA), Zimmermann; Holger (Falkensee, DE)
Assignee: Bayer Pharma Aktiengesellschaft (Berlin, DE)
Application Number:11/609,705
Patent Claim Types:
see list of patent claims
Use;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 62nd percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Bayer Hlthcare
NATAZIA
dienogest; estradiol valerate
TABLET;ORAL022252-001May 6, 2010RXYes8,153,616► subscribe TREATMENT OF HEAVY MENSTRUAL BLEEDING IN WOMEN WITHOUT ORGANIC PATHOLOGY WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION
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International Patent Family for Patent: 8,153,616

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina056694► subscribe
Austria424828► subscribe
Austria497387► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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