US Patent

US8153616 — Combination preparation for oral contraception and oral therapy of dysfunctional uterine bleeding containing estradiol valerate and dienogest and method of using same

Method of Use · Assigned to Bayer Pharma AG · Expires 2028-01-30 · 2y remaining

Vulnerability score 80/100 Vulnerable — likely target for IPR or design-around

What this patent protects

This patent protects a combination oral contraceptive and treatment for dysfunctional uterine bleeding containing estradiol valerate and dienogest.

USPTO 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.

Drugs covered by this patent

FDA Patent Use Codes

When a patent is method-of-use, FDA lists it once per applicable indication ("U-code"). Each U-code carves out a specific therapeutic use that generic filers must either license or design around.

CodeDescriptionDrug
U-1240 Natazia

Patent Metadata

Patent number
US8153616
Jurisdiction
US
Classification
Method of Use
Expires
2028-01-30
Drug substance claim
No
Drug product claim
No
Assignee
Bayer Pharma AG
Source
FDA Orange Book + USPTO grounding via Google Patents

Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.

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