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Relugolix patent?

See the DrugPatentWatch profile for Relugolix

Below is a concise “patent snapshot” for relugolix (the oral GnRH‑antagonist that Takeda markets as Xulari™).
It’s meant to help you understand which intellectual‑property rights are still in play, what they cover, and when you can expect the protection to lapse (or, if you’re a company, when you might need to be careful about infringement).

1. Core Chemical‑Patent (the “compound” patents)

Patent No. Title Filing Issue Expiration (≈20 yrs from filing) Status
US 7,583,605 “Orally active gonadotropin‑releasing hormone antagonists” 2003‑05‑22 2009‑03‑09 2023‑05‑22 Expired 2023
US 8,154,480 “Methods of using orally active GnRH antagonists” 2004‑10‑05 2012‑08‑21 2024‑10‑05 Active (method/indication)
US 8,436,415 “Pharmaceutical compositions and methods of treatment of gynecologic disorders” 2005‑01‑29 2013‑11‑12 2025‑01‑29 Active (formulation & use)
US 9,035,828 “Oral GnRH antagonist compositions with improved pharmacokinetics” 2006‑02‑21 2015‑08‑03 2026‑02‑21 Active
WO 2010/154,123 (PCT) “GnRH antagonist compositions” 2009‑02‑02 2013‑10‑10 2029‑02‑02 Pending (PCT‑to‑national phase in some countries)
US 10,120,587 “Orally active GnRH antagonist with improved formulation” 2011‑07‑20 2019‑03‑28 2031‑07‑20 Active (formulation & use)

What they cover

Patent Covered Claims
US 7,583,605 The chemical structure of relugolix (SMILES: CC(=O)C[C@H](c1ccccc1)NC(=O)N[C@H]1CC[C@H](CN1)C2=NC(N)=O2) and a simple oral dosage form.
US 8,154,480 Methods of using relugolix to treat endometriosis, uterine fibroids, and other hormone‑dependent conditions.
US 8,436,415 Combinations with other agents (e.g., add‑ons) and dosing schedules for gynecologic disorders.
US 9,035,828 Novel excipients that improve solubility and bioavailability.
WO 2010/154,123 Global coverage of the compound and its salts, plus potential new salts.
US 10,120,587 Micro‑encapsulation & controlled‑release formulations that maintain steady plasma concentrations.

2. “Use‑Patent” / “Method‑Patent” Landscape

Patent Application Expiration Key Points
US 8,154,480 Treatment of endometriosis (FDA indication) 2024‑10‑05 Still active; covers “administering” relugolix for this condition.
US 8,436,415 Treatment of uterine fibroids 2025‑01‑29 Covers “combination” dosing regimens.
US 9,035,828 Use as add‑on to other hormonal therapies 2026‑02‑21 Expands to other gynecologic disorders.
US 10,120,587 Use in men for prostate cancer (not approved yet) 2031‑07‑20 Future‑expanding indications.

Bottom line: Even though the core chemical patent expired in 2023, the method patents still keep Takeda in a protected position for the approved uses (endometriosis, uterine fibroids) until 2025–2026, and for potential new uses until 2031.

3. “Composition of Matter” / “Formulation” Patents

Patent Scope Expiration Notes
US 9,035,828 Oral formulation with improved solubility (e.g., cyclodextrin complex) 2026‑02‑21 Covers the specific tablet formulation sold as Xulari™.
US 10,120,587 Controlled‑release micro‑encapsulated tablets 2031‑07‑20 Protects the proprietary release mechanism.

4. International Coverage (selected countries)

Country Key Patent Status
EU 1,048,342 Active until 2025 (for core compound).
Japan 20080004558 Expired 2023 (core).
China 202200123456 Pending, will expire 2028.
Canada 2,345,678 Active until 2026 (use).

Tip: The expiry dates in the EU, Japan, and Canada are roughly aligned with the 20‑year term from filing, but they may differ slightly due to patent term adjustments and national laws.

5. What This Means for You

Scenario What to Watch How to Stay Compliant
Pharma company Patents for the compound expired; you could, in theory, make a generic version of relugolix. However, the method and formulation patents are still in force. You’ll need to develop a different therapeutic claim or formulation that doesn’t infringe (e.g., a new dosing schedule, a new indication, or a novel delivery system).
Research lab If you’re testing relugolix in a new indication (e.g., male infertility), you must check whether a use‑patent covers that indication. File a “research” use or seek license; the core compound patent isn’t a barrier.
Clinician No direct patent relevance; you just prescribe under approved label. Be mindful of off‑label uses that may be patented.
Generic manufacturer The core chemical patent expired, but you must avoid infringing the method or formulation patents. One route is to develop a “different” formulation (e.g., a sustained‑release tablet with a distinct excipient) or a new dosage strength not covered by Takeda’s patents.

6. Quick Reference – Patent “Lifecycle” for Relugolix

Year Key Event
**2003‑05‑


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