US Patent 11,707,464: Elagolix Endometriosis Claims, Scope and Patent Landscape

US Patent 11,707,464 protects patient-selection, dosing-duration, bone-mineral-density monitoring, and treatment-management methods for elagolix 150 mg once daily in premenopausal women with moderate to severe endometriosis pain. The patent does not claim the elagolix molecule itself. Its commercial relevance is concentrated in the 24-month Orilissa 150 mg once-daily regimen, particularly where treatment occurs without hormonal add-back therapy and involves bone-health screening or monitoring.

The claims are method-of-treatment claims. Infringement requires practice of every limitation in an asserted claim, including the patient population, dose, frequency, duration, disease indication, treatment outcome, add-back limitation, and, for selected claims, bone-mineral-density or osteoporosis-related conditions.

What does US Patent 11,707,464 cover?

The patent has four independent method claims: claims 1, 7, 16, and 22. Each targets a different risk-management configuration for long-term elagolix therapy.

Independent claim	Core protected subject matter	Principal limiting conditions
Claim 1	Elagolix 150 mg once daily for 24 months	Moderate to severe endometriosis pain; reduced dysmenorrhea and non-menstrual pelvic pain; no increased concomitant pain medication; lumbar-spine BMD decline limited to 2% at six months and 8% at 24 months; no add-back therapy
Claim 7	Elagolix 150 mg once daily for a maximum of 24 months	Duration cap intended to limit BMD loss; pain reduction; no add-back therapy
Claim 16	Treatment of women with no known osteoporosis	Determination that the patient has no known osteoporosis; 150 mg once daily for 24 months; pain reduction; no add-back therapy
Claim 22	Treatment of patients with bone-risk history	Low-trauma fracture history or condition associated with reduced BMD; selection of a BMD-mitigating regimen; 150 mg once daily for 24 months; no add-back therapy

The claims identify elagolix by its full chemical name and require administration as the sodium salt. This chemical definition corresponds to elagolix sodium, the active pharmaceutical ingredient in Orilissa.

The patent therefore sits in the use-patent layer of the elagolix estate. It does not principally protect:

The underlying elagolix composition of matter
A generic elagolix sodium molecule
A particular tablet excipient system
A manufacturing process
Hormonal add-back combinations such as estradiol and norethindrone acetate

How do claims 1 through 27 differ?

Claims 1, 7, 16, and 22 establish separate independent infringement pathways. The dependent claims add narrower patient, monitoring, supplement, analgesic, or outcome limitations.

Claims 1 through 6: BMD-outcome claims

Claim 1 is the most clinically detailed claim set. It requires:

A premenopausal adult human female.
Moderate to severe pain associated with endometriosis.
Oral elagolix sodium at 150 mg once daily.
Treatment for 24 months.
Reduction in dysmenorrhea and non-menstrual pelvic pain.
No increase in use of concomitant endometriosis pain medication.
No more than 2% lumbar-spine BMD reduction at six months.
No more than 8% lumbar-spine BMD reduction at 24 months.
No add-back therapy.

Claims 2 and 3 narrow the concomitant-medication limitation to analgesics, including anti-inflammatory drugs or opioids. Claim 4 excludes patients with osteoporosis. Claims 5 and 6 add calcium or vitamin D supplementation and pre-treatment BMD assessment.

The BMD limitations create both evidentiary value and enforcement complexity. A patentee would need to establish the relevant baseline, measurement methodology, lumbar-spine site, timing, and patient-specific percentage change. A generic sponsor could challenge whether those outcome limitations are inherent, consistently observed, or satisfied across the accused treatment population.

Claims 7 through 15: 24-month duration-limit claims

Claim 7 focuses on the treatment duration. It requires administration that “does not exceed 24 months” to limit BMD loss associated with elagolix exposure.

The claim is broader than claim 1 in one respect because it does not require the specific 2% and 8% BMD thresholds in the independent claim. Claims 14 and 15 add those thresholds as dependent limitations.

Claim 7 also does not require the patient to have no osteoporosis. That condition appears in claims 11 and 16. Claims 8 through 10 add the no-increase-in-analgesic-use limitation and specify anti-inflammatory drugs or opioids.

The duration language is commercially important because the FDA-approved Orilissa labeling provides a 24-month limitation for the 150 mg once-daily regimen. The label also limits the 200 mg twice-daily regimen to six months because of bone-loss concerns. [2]

Claims 16 through 21: Osteoporosis-screening claims

Claim 16 requires determining that the patient has no known history of osteoporosis before administering elagolix.

This claim is directed to clinical decision-making rather than only to drug delivery. Potential infringement questions include:

Whether the prescriber or provider made the required determination
Whether “no known history” requires an affirmative review of medical records
Whether a patient’s undocumented osteoporosis status satisfies the limitation
Whether an electronic prescribing protocol or treatment guideline performs the determination

Claims 20 and 21 cover calcium or vitamin D supplementation and pre-treatment BMD assessment. The claim does not require a specific BMD value or a DXA scan result. It requires the patient-selection determination and the specified treatment course.

Claims 22 through 27: Patients with bone-risk histories

Claim 22 addresses women with either:

A history of low-trauma fractures; or
A history of a condition associated with decreased BMD.

The claim requires providing a dosage form containing 150 mg or 200 mg, determining the patient’s bone-risk history, selecting a regimen suitable to mitigate further BMD decreases, and then administering 150 mg once daily for 24 months.

This claim is structurally unusual because it recites a dosage form containing either 150 mg or 200 mg, but the selected regimen ultimately requires administration of 150 mg. A product containing only 150 mg would fall within the dosage-form language if all remaining limitations were met. A 200 mg product would not necessarily infringe through administration of 200 mg, because the claim specifies the selected 150 mg regimen.

Claims 23 and 24 add supplementation and pre-treatment BMD assessment. Claims 25 through 27 add the no-increased-analgesic-use limitation.

What patents protect Orilissa and elagolix?

Elagolix has multiple potential patent layers:

Patent layer	Typical subject matter	Relevance to US 11,707,464
Composition of matter	Elagolix and related GnRH antagonists	Earlier foundational protection
Salt and solid-state forms	Elagolix sodium, polymorphs, crystallinity, stability	May affect active-ingredient and product manufacture
Formulation	Tablets, excipients, release and stability characteristics	Relevant to finished-dose products
Endometriosis methods	Dosing, duration, patient selection, symptom control	Direct subject of US 11,707,464
Uterine-fibroid methods	Elagolix regimens for heavy menstrual bleeding and fibroids	Separate indication and claim scope
Combination therapy	Elagolix with estradiol, norethindrone, or other add-back agents	Distinct from the no-add-back claims here
Manufacturing	Synthesis, purification, salt formation, and processing	Potential barrier to API suppliers and generic manufacturers

The principal commercial distinction is between Orilissa and Oriahnn. Orilissa contains elagolix alone and is approved for moderate to severe pain associated with endometriosis. Oriahnn combines elagolix with estradiol and norethindrone acetate and is approved for heavy menstrual bleeding associated with uterine fibroids. [2,3]

US 11,707,464 is focused on the Orilissa-type, no-add-back use case. It does not read naturally on a regimen that necessarily includes add-back therapy because each independent claim expressly excludes administration of add-back therapy.

What is the FDA and Orange Book status of US 11,707,464?

The FDA approved Orilissa in 2018 for moderate to severe pain associated with endometriosis. The approved dosing options are 150 mg once daily for up to 24 months and 200 mg twice daily for up to six months. [2]

The patent claims track the 150 mg once-daily, 24-month limitation in the FDA label. That alignment increases the patent’s potential relevance to an ANDA applicant seeking approval of an elagolix product for the same indication.

An Orange Book listing must be assessed separately from the claim language. The presence of a patent directed to a method of treatment does not, by itself, establish that the patent is listed for Orilissa. Orange Book relevance depends on FDA listing records, the approved product labeling, and whether the patent claims an approved method of using the drug. [4]

A generic sponsor could seek approval with a section VIII statement carving out a patented method of use if the proposed labeling omits the protected indication or regimen. If the proposed labeling includes the endometriosis indication and the patented 150 mg regimen, a Paragraph IV certification may be required for listed patents. [5]

When does elagolix lose exclusivity?

The commercial exclusivity analysis has separate patent and regulatory components.

Exclusivity component	Practical effect
New chemical entity exclusivity	Blocks certain ANDA approvals for the statutory NCE period
Patent protection	Can delay approval or launch depending on listing, certification, litigation, and settlement
Pediatric exclusivity	Can add six months if awarded
Method-of-use protection	Can be avoided through a compliant label carve-out in some circumstances
Formulation or product patents	Can create separate barriers even after method claims expire

The earliest expiration date of US 11,707,464 depends on its effective patent-term calculation, including the earliest relevant nonprovisional filing date, patent-term adjustment, and any terminal disclaimer. The patent issued on August 29, 2023, according to the supplied patent number and public patent record. The enforceable term cannot be determined from the claim text alone.

The 24-month treatment limitation is not an expiration date. It limits the claimed therapy for each patient. It does not mean that the patent expires after 24 months of treatment.

Which companies are challenging the Orilissa patent estate?

The main generic risk would come from ANDA applicants seeking approval for elagolix tablets or therapeutically equivalent products. A Paragraph IV challenge could target:

The validity of the method claims
Written description and enablement
Obviousness of the 150 mg, 24-month regimen
Whether the BMD limitations are adequately supported
Whether the claims are anticipated by clinical-trial or label disclosures
Whether the claims are infringed by a proposed generic label
Whether a section VIII carve-out avoids the claimed use

A label-carve-out strategy is more feasible for claims requiring the endometriosis indication, 150 mg once-daily dosing, or a 24-month duration. It becomes more difficult if the generic label retains the same indication and dosing instructions as Orilissa.

No claim in US 11,707,464 covers all elagolix prescribing. The claims are limited to a specific patient population and regimen. That creates potential design-around routes, including different dosing, a different labeled duration, an add-back regimen, or omission of the endometriosis indication. Each route must be evaluated against the full Orange Book patent set, not this patent alone.

How strong is the patent estate for US 11,707,464?

The patent has meaningful commercial strength because its central limitations correspond closely to the approved Orilissa regimen. The strongest practical features are:

The specific 150 mg once-daily dose
The 24-month duration
The endometriosis pain indication
The absence of add-back therapy
The patient-selection and bone-health limitations

The principal weaknesses are claim-specific and evidentiary.

Legal vulnerability

The claims may face obviousness arguments based on known elagolix dosing, known GnRH-antagonist bone-loss risks, clinical-trial data, and the FDA-approved 24-month limitation. A challenger could argue that selecting a 150 mg regimen for no more than 24 months was an expected response to known dose-duration toxicity.

Proof of infringement

Claims 1 and 7 require treatment outcomes or clinical conditions that may not appear in a generic label. A generic product may be sold for the same indication without every patient experiencing the claimed BMD change or symptom response. Outcome-dependent limitations can complicate inducement allegations.

Patient-specific limitations

Claims 16 and 22 depend on medical history, BMD risk, or provider decision-making. These limitations may reduce direct product-level infringement exposure but increase the importance of prescribing systems, clinical protocols, and promotional materials.

No-add-back limitation

The no-add-back limitation narrows the claims against Oriahnn-type products. It also creates a potential distinction between standalone elagolix and combination regimens.

What litigation and settlement risks affect generic entry?

A Paragraph IV litigation involving a listed patent can trigger a 30-month stay of FDA approval under the Hatch-Waxman framework, subject to statutory exceptions and court developments. [5]

Potential settlement structures include:

Delayed generic entry before patent expiration
A licensed entry date
A nonexclusive license for specific strengths or indications
A covenant not to sue for carved-out uses
Restrictions on launch conditions
Agreements tied to patent litigation resolution

The commercial risk is highest where a proposed generic label reproduces the Orilissa indication and 150 mg once-daily regimen. The risk is lower where the applicant can use a valid section VIII carve-out without undermining approval or marketing the product for the patented method.

How does US 11,707,464 compare with elagolix formulation patents?

Formulation patents generally attach to the product itself. They can create broader supply-chain exposure because infringement may occur through making, importing, offering for sale, or selling a claimed tablet or formulation.

US 11,707,464 is narrower in product terms but broader in clinical-use terms. It does not require a particular excipient, tablet architecture, dissolution profile, or manufacturing step. Its enforcement focus is the prescribed regimen and patient management.

A generic manufacturer therefore needs two separate analyses:

Whether its product infringes formulation, salt, solid-state, or manufacturing patents.
Whether its label, promotion, or prescribing support induces the claimed treatment methods.

Avoiding the patented clinical method does not eliminate API, formulation, or process-patent exposure.

What generic launch scenarios exist for elagolix?

Launch scenario	Patent exposure	Commercial assessment
Full-label generic for endometriosis, 150 mg once daily	High exposure to method claims and any listed patents	Most direct challenge route
Section VIII carve-out of endometriosis use	Lower exposure to method claims	Viable only if FDA labeling and marketing remain compliant
Generic 200 mg-only product	Avoids the claimed 150 mg administration in this patent	Other patents and regulatory requirements remain relevant
Add-back combination product	Outside the express no-add-back limitation	May implicate separate combination patents
Authorized generic or license entry	Depends on settlement or license terms	Can reduce litigation risk but affects economics
Post-expiration launch	No live patent risk from the expired patent	Subject to other unexpired patents and regulatory exclusivity

What revenue exposure does the patent create?

The patent’s revenue exposure is tied to Orilissa sales attributable to the 150 mg once-daily regimen. It does not directly cover every elagolix indication or formulation.

The most exposed segment is long-duration endometriosis treatment in patients without add-back therapy. The 200 mg twice-daily regimen is less directly implicated because the independent claims require 150 mg once daily. Oriahnn revenue is also less directly exposed because the claims exclude add-back therapy and target endometriosis pain rather than uterine-fibroid bleeding.

Commercial damages could be based on lost sales, reasonable royalty, or other statutory remedies, depending on the litigation posture and proof of induced or direct infringement. The patent’s value is therefore highest if it is listed, survives validity challenges, and supports an enforceable label-based infringement theory.

Key Takeaways

US 11,707,464 is a clinical-use patent for elagolix sodium, not a composition-of-matter patent.
Its core commercial target is 150 mg elagolix once daily for up to 24 months for endometriosis pain.
Every independent claim excludes add-back therapy.
Claims 1, 16, and 22 add BMD, osteoporosis, fracture-history, or bone-risk requirements.
Claims 7 through 15 focus on the 24-month duration cap and related BMD outcomes.
The patent aligns closely with the FDA-approved Orilissa 150 mg regimen.
Generic exposure depends heavily on Orange Book listing, proposed labeling, Paragraph IV certifications, and the feasibility of a section VIII carve-out.
The patent does not directly cover the 200 mg administration regimen or elagolix add-back combinations.
Formulation, salt, manufacturing, and other method-of-use patents must be analyzed separately.
The patent’s enforceable expiration date requires the official patent-term calculation, including PTA and any terminal disclaimer.

FAQs

Does US Patent 11,707,464 cover Orilissa 200 mg twice daily?

No. The independent claims principally require administration of 150 mg elagolix once daily. Claim 22 mentions a dosage form containing 150 mg or 200 mg, but the selected regimen still requires administration of 150 mg once daily.

Can a generic company sell elagolix with a section VIII carve-out?

Potentially. A section VIII carve-out may avoid a patented method if the generic labeling and marketing omit the protected indication or regimen. The strategy must account for every listed patent and the FDA-approved labeling requirements.

Does calcium or vitamin D supplementation avoid infringement?

No. Claims 5, 12, 20, and 23 expressly include calcium, vitamin D, or both as dependent limitations. Supplementation is not a general safe harbor from the independent claims.

Does the patent cover patients with osteoporosis?

The independent claims either exclude osteoporosis or require no known history of osteoporosis. Claim 22 instead addresses patients with a history of low-trauma fractures or a condition associated with reduced BMD. The claim set does not broadly cover treatment of all patients with osteoporosis.

Is the patent relevant to Oriahnn?

Its relevance is limited. Oriahnn includes elagolix with estradiol and norethindrone acetate, while every independent claim here excludes add-back therapy. Separate patents and regulatory protections may apply to the combination product.

References

United States Patent and Trademark Office. (2023). United States Patent No. 11,707,464.
U.S. Food and Drug Administration. (2024). Orilissa (elagolix) prescribing information. AbbVie Inc.
U.S. Food and Drug Administration. (2024). Oriahnn (elagolix, estradiol, and norethindrone acetate) prescribing information. AbbVie Inc.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book.
U.S. Food and Drug Administration. (2024). Abbreviated New Drug Application regulations and patent certification requirements under the Hatch-Waxman Amendments.

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	11,707,464	⤷ Start Trial				MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG ELAGOLIX FOR UP TO 24 MONTHS	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2906894	⤷ Start Trial
European Patent Office	2968566	⤷ Start Trial
European Patent Office	3384930	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,707,464

Which drugs does patent 11,707,464 protect, and when does it expire?

Summary for Patent: 11,707,464