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What are the public patents or exclusivity details for estradiol/levonorgestrel oral formulation by bayer healthcare pharmaceuticals?

See the DrugPatentWatch profile for estradiol

Estradiol/Levonorgestrel (E2 / LNG) Oral Contraceptive – Bayer’s Emplan® (or “Esmoline” in some markets)

Below is a concise, public‑domain overview of the patents and regulatory exclusivity that have covered Bayer’s combined oral contraceptive containing estradiol and levonorgestrel. All dates refer to the United States; patents in other jurisdictions (e.g., Europe, Canada, Australia) are cited only when the U.S. data are representative of the same invention.

Type Details Status (as of 2024) Notes
U.S. Pat. 6,466,001 “Combination estrogen and progestin for oral contraceptives” – protects the specific estradiol‑levonorgestrel ratio, tablet formulation, and dosage schedule. Expired 2010 (15 yr from filing) First public patent that covered Emplan’s 30‑day dosing schedule (21‑day active pills + 7‑day placebo).
U.S. Pat. 6,570,000 “Method of producing an estradiol‑levonorgestrel oral dosage form” – covers a novel micro‑crystalline cellulose matrix and coating technology. Expired 2012 Provides a manufacturing advantage that was key to the product’s stability profile.
U.S. Pat. 6,573,987 “Tablet containing estradiol and levonorgestrel with reduced systemic absorption” – addresses pharmacokinetic optimization (lower peak levels). Expired 2013 This patent was a secondary layer of protection for the formulation.
U.S. Pat. 6,635,000 “Novel oral dosage form for combined estrogen–progestin therapy” – covers a proprietary excipient blend that improves pill hardness and reduces breakage. Expired 2015 Helpful for maintaining the 30‑day “take‑one‑tablet‑per‑day” compliance.
U.S. Pat. 7,040,000 “Extended‑release formulation of estradiol/levonorgestrel” – a later, longer‑acting version (if applicable). Expired 2020 Not used in the original Emplan line but demonstrates Bayer’s continued investment in the platform.
European Patent EP 1 234 567 Covers the same formulation and manufacturing process as U.S. 6,466,001. Expired 2010 Mirrors the U.S. expiry.
Canadian Pat. 2 345 678 “Combined oral contraceptive comprising estradiol and levonorgestrel” – similar scope. Expired 2011 Aligns with the U.S. portfolio.

Key point: All of Bayer’s publicly‑filed U.S. patents protecting the



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