Details for Patent: 10,682,351

Which drugs does patent 10,682,351 protect, and when does it expire?

Patent 10,682,351 protects ORILISSA and is included in one NDA.

This patent has six patent family members in five countries.

Summary for Patent: 10,682,351

Title:	Methods of administering elagolix
Abstract:	The present disclosure relates to the use of GnRH receptor antagonists used in the treatment of endometriosis or uterine fibroids. In particular, the present disclosure describes a method of treating endometriosis or uterine fibroids, where the method involves the administration of elagolix, and where the method may further involve the co-administration of rifampin or ketoconazole.
Inventor(s):	Sandra L. Goss, Cheri E. Klein, Juki Wing-Keung Ng, Ahmed Salem
Assignee:	AbbVie Inc
Application Number:	US16/722,741
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,682,351
Patent Claim Types: see list of patent claims	Use;

US Patent 10,682,351 (Elagolix): Scope of Claims, Active-Drug/Drug-Interaction Limits, and U.S. Patent Landscape for Endometriosis Treatment

US Patent 10,682,351 has a single, highly specific claim scope tied to an endometriosis treatment method using elagolix (as a sodium salt) with a defined oral dosing equivalence and a co-administered drug-drug interaction: ketoconazole dosed at 400 mg once daily, producing specified PK increases (Cmax and AUC) for elagolix. The practical effect is a narrow, “stacked” patent claim that is most likely aimed at combination regimens where a strong CYP3A inhibitor is used to boost elagolix exposure.

What does US Patent 10,682,351 claim, and how narrow is the method?

Featured snippet answer: Claim 1 is limited to (i) treating endometriosis, (ii) orally administering elagolix as a sodium salt equivalent to 150 mg free acid once daily, and (iii) concurrently dosing the patient with ketoconazole 400 mg once daily, where PK parameters show at least specified fold increases for elagolix Cmax and AUC versus elagolix alone.

Claim 1 elements (requirement-by-requirement)

Claim 1 requires all of the following, written as functional and quantitative limitations:

1. Indication

   • “A method for treating endometriosis in a patient…”

2. Dosage form and active

   • “Orally administering… elagolix as a sodium salt”
   • The sodium salt is administered in an amount equivalent to 150 mg of the free acid.

3. Dosing frequency

   • “Once daily 150 mg equivalent” (claim states once daily administration of the sodium salt).

4. Co-administered drug and dose

   • “Wherein the patient receives a once daily dose of 400 mg ketoconazole.”

5. Pharmacokinetic relationship

   • “Maximum plasma concentration for elagolix is increased by 1.8 fold relative to elagolix alone.”
   • “Plasma area-under-the-curve for elagolix is increased by 2.2 fold relative to elagolix alone.”

How that structure affects enforceability and design-around

The claim’s enforceability is tied to both fixed regimen parameters and measured PK outcomes:

• Fixed regimen parameters create direct infringement risk only if the accused regimen matches the sodium-salt/150 mg equivalent elagolix exposure plan and the coadministration includes ketoconazole 400 mg once daily.
• The PK outcome constraints mean an accused regimen can avoid infringement if its measured Cmax and AUC fold-changes do not meet the claimed thresholds or are measured under materially different conditions that change comparators.

From a patent landscape perspective, this is not a “broad use” claim (like “increasing exposure of elagolix with CYP3A inhibitors”); it is a claim drafted to a specific pairing and a specific exposure profile.

What patents cover elagolix endometriosis treatment in the U.S., and where does this claim fit?

US Patent 10,682,351 sits in a segment of the elagolix estate focused on drug-drug interactions (DDIs) and exposure modulation, not basic therapeutic use alone. The typical elagolix U.S. patent architecture (across multiple families) divides into:

• Active ingredient / chemical composition (core elagolix matter)
• Salt forms and/or specific salt properties
• Formulations and dosing regimens
• Method-of-use for endometriosis
• DDI and exposure boosting, including strong CYP3A inhibitor interaction studies
• Manufacturing and intermediates (nonclinical, process-focused protection)

Given the claim’s content, 10,682,351 is best categorized as DDI method-of-treatment protection tied to a CYP3A inhibition mechanism via ketoconazole. That typically complements broader endometriosis-treatment patents rather than replacing them.

What is the practical claim “role” in litigation?

For a DDI-focused claim, enforcement strategies usually target:

• Prescribing patterns that match the exact label-adjacent or off-label regimen used in clinical practice
• Marketing or promotional materials for combination regimens
• Regulatory documents that reference similar PK findings

Because the claim is not limited to a label indication alone but requires an endometriosis treatment context, the “use” portion can increase litigation complexity versus a purely composition/kit claim, but the ketoconazole + 150 mg sodium salt equivalent specificity reduces the number of plausible accused regimens.

What are the key claim construction risks for US 10,682,351 (scope of “increased by 1.8 fold” and “2.2 fold”)?

Featured snippet answer: Claim 1 requires that Cmax and AUC are increased by at least the specified fold values versus elagolix alone, so claim construction will hinge on (i) which study design serves as the “relative to elagolix alone” comparator and (ii) the measurement conditions that can alter PK results.

Fold-increase comparator: “relative to administration of elagolix alone”

The claim uses a comparative phrase that can introduce evidentiary and construction issues:

• Comparator cohort: The claim implies a condition where elagolix is administered alone, and PK is measured in that baseline.
• Measurement window and endpoints: “Maximum plasma concentration” and “area-under-the-curve” are standard PK endpoints, but fold values can change based on sampling schedule, assay, and population characteristics.

Endpoint thresholds as infringement gating

The claim provides explicit numeric thresholds:

• Cmax: 1.8 fold
• AUC: 2.2 fold

This reduces the claim’s “conceptual scope” and increases the “technical scope” burden. In practice, infringement proofs must map the accused regimen’s measured endpoints to the thresholds.

How does the ketoconazole interaction limitation shape potential generic entry risk?

Featured snippet answer: Since the claim is tied to ketoconazole 400 mg once daily and specific PK fold increases, generic elagolix manufacturers face lower direct risk from purely “generic elagolix” launch activity unless they market, instruct, or test combination regimens that meet the claim’s numeric PK outcome conditions.

Risk pathways for generics or biosimilar-like substitutes (small molecule context)

Unlike biologics, elagolix is a small molecule. The main exposure routes to this type of claim include:

• Labeling and labeling-adjacent instructions for coadministration with strong CYP3A inhibitors
• Educational and promotional materials that describe PK-boosting strategies
• Clinical bridging or bioequivalence studies that evaluate interactions in a way that triggers the method claim

A generic firm could argue that its approval only covers elagolix alone and not the claimed ketoconazole regimen. But method claims can still be implicated by actual prescribing and use, especially where materials support the combination as medically appropriate.

What Orange Book status is relevant to this patent type?

Featured snippet answer: This is a U.S. method patent that can be listed in the Orange Book only if it is tied to an approved drug product and listed as covering a protected use. The Orange Book listing matters for Paragraph IV challenge strategy and FDA-related Orange Book dispute flow, but actual infringement is determined by method performance, not listing alone.

In practical terms, for a method patent like this:

• It is Orange Book impact depends on whether the patent is listed for an approved elagolix NDA product and for a relevant protected use.
• A Paragraph IV filer typically challenges listed patents tied to the NDA product; unlisted patents are often not reachable via the specific Orange Book litigation trigger mechanism, though infringement can still be pursued outside that pathway.

When does US 10,682,351 expire, and how does exclusivity differ from patent term?

US 10,682,351’s expiration depends on:

• the application filing date and the patent term rules applicable in force at issuance, plus any adjustments (PTA) and any term extensions.
• whether the patent has been validated/extended in any way affecting enforceability in the U.S.

This answer cannot be completed without the patent’s bibliographic data (filing date, priority, PTA/PTD, and any terminal disclaimer terms). The claim text alone does not provide a reliable expiration schedule.

How strong is the patent estate for elagolix versus competing endometriosis therapies?

Featured snippet answer: Claim 1 is narrow in dosing and coadministration, but the estate strength depends on whether broader elagolix-method, formulation, salt, and composition patents also cover the same commercial regimen space. A narrow DDI-method claim can still be commercially relevant because it targets a practical prescribing pattern (using a strong CYP3A inhibitor to raise exposure).

Portfolio “strength” drivers for this claim category

Key factors that usually determine how much value an interaction-method patent contributes:

• Whether there are multiple layers (composition/formulation + method-of-use + DDI) protecting the same branded regimen
• Whether the DDI claim is listed in the Orange Book for the approved product(s)
• Whether the claim is supported by multiple in vivo PK studies in the specification that support the exact fold thresholds
• Whether there are related claims in the same patent family that cover other CYP3A inhibitors or other elagolix dose equivalents

Because the prompt provides only Claim 1, and not the dependent claims (if any), full estate strength cannot be mapped precisely here.

Does US 10,682,351 cover other CYP3A inhibitors beyond ketoconazole?

Featured snippet answer: Claim 1, as provided, is explicitly limited to ketoconazole 400 mg once daily, so coverage beyond ketoconazole depends on the existence of other claims or other patents in the family that recite different inhibitor drugs or different dosing.

The limitation to ketoconazole in Claim 1 is a straightforward narrowing device. If the patent family contains additional claims, they could expand to:

• other CYP3A inhibitors
• other dose equivalents of elagolix sodium salt
• different fold increase targets
• different dosing schedules

No such expansion can be asserted from the single claim text provided.

How does this claim compare with other DDI-based patent claim patterns?

Featured snippet answer: Typical DDI claims in pharmaceuticals can be broad (class of inhibitors, exposure increase concept) or narrow (specific inhibitor, dose, regimen, and numeric PK endpoints). US 10,682,351 follows the narrow numeric/compound-specific model.

Narrow DDI claim characteristics

Compared to broader “use with CYP3A inhibitor” language, this claim:

• identifies ketoconazole by name
• specifies dose (400 mg once daily)
• specifies elagolix salt equivalence (150 mg free acid equivalent)
• specifies quantified exposure changes (1.8-fold Cmax, 2.2-fold AUC)

That combination is generally less vulnerable to overbreadth attacks but more vulnerable to “non-infringement by mismatch” (different doses, different comparator baselines, or different observed fold-changes).

What patent litigation does this kind of method claim tend to trigger?

Featured snippet answer: Method claims tied to DDI regimens typically arise in Orange Book disputes, then continue into disputes about prescribing/use and evidence of PK performance under real-world or clinical protocols.

For 10,682,351 specifically, the key litigation issues would likely be:

• whether the accused product is elagolix sodium salt capable of the claimed administration
• whether the accused regimen matches ketoconazole 400 mg once daily concurrently
• whether measured PK outcomes meet the claimed fold increase thresholds
• claim construction of “once daily” dosing timing and what constitutes “elgagolix alone” baseline

No case caption or docket details were provided here, so no specific litigation schedule can be stated.

Key takeaways for R&D, licensing, and freedom-to-operate

1. US 10,682,351 is a narrow DDI method claim anchored to a specific coadministration (ketoconazole 400 mg once daily) and specific PK endpoints (Cmax 1.8-fold; AUC 2.2-fold) for an elagolix sodium-salt regimen equivalent to 150 mg free acid once daily.
2. Generic elagolix launch alone is not the whole risk question. The method claim is triggered by use of a combination regimen that matches the claim’s defined pairing and exposure outcome.
3. Design-around is most feasible by avoiding the exact dosing pair (ketoconazole 400 mg) or by ensuring any evaluated regimen yields PK outcomes that fall short of the claimed fold thresholds.
4. For enforcement, evidence will focus on PK comparators (“relative to elagolix alone”) and endpoint measurement under the accused regimen conditions.
5. For licensing strategy, the claim’s value is tied to actual clinical use of ketoconazole as an exposure-boosting agent in patients treated for endometriosis using elagolix sodium salt at the claimed dose equivalence.

FAQs

1) Is the ketoconazole limitation enforceable even if only used off-label?

The claim does not recite “FDA-approved” or “label” language. If a regimen performed in practice satisfies the claim elements, method infringement risk remains.

2) Would a different ketoconazole dose avoid infringement?

If the dosing does not match “400 mg once daily,” and the resulting PK fold increases do not meet the claim thresholds, the regimen can fall outside Claim 1 as provided.

3) Do PK endpoints need to be measured in every patient for infringement?

The claim requires that endpoints are increased relative to elagolix alone; the litigation evidentiary approach typically uses studies or representative PK data tied to the accused regimen rather than every individual’s measurements.

4) Does “sodium salt equivalent to 150 mg free acid” cover all elagolix sodium salt products?

Coverage depends on whether the administered amount is “equivalent to 150 mg of the free acid” and whether the accused product and regimen satisfy the oral once-daily administration element.

5) Can Orange Book listing alone determine infringement?

No. Orange Book listing is procedural context for patent challenges, but infringement is determined by performing the claimed method.

References

1. U.S. Patent No. 10,682,351.

Drugs Protected by US Patent 10,682,351

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018		RX	Yes	No						MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG ELAGOLIX WHILE CO-ADMINISTERING KETOCONAZOLE

International Family Members for US Patent 10,682,351

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016317955
Australia	2021204104
Canada	3002791