United States Patent 11,045,470: Claim Scope, Oriahnn Exclusivity, and Elagolix Patent Landscape

U.S. Patent No. 11,045,470 protects a specific Oriahnn dosing regimen for heavy menstrual bleeding associated with uterine fibroids. The core limitation is twice-daily elagolix at 300 mg per dose, combined in the morning dose with estradiol 1.0 mg and norethindrone acetate 0.5 mg. The claims also require limiting elagolix-related bone mineral density loss to less than 8% after 24 weeks.

The patent is a method-of-treatment patent, not a broad composition patent. Its commercial relevance is strongest against an ANDA applicant seeking to market the same elagolix-plus-add-back regimen for uterine-fibroid-associated heavy menstrual bleeding.

What drug and product does U.S. Patent 11,045,470 protect?

U.S. Patent 11,045,470 covers the dosing regimen used for Oriahnn, an oral treatment approved by the FDA for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Product	Active ingredients	Relevant dosing
Oriahnn morning capsule	Elagolix sodium equivalent to 300 mg elagolix, estradiol 1.0 mg, norethindrone acetate 0.5 mg	Once each morning
Oriahnn evening capsule	Elagolix sodium equivalent to 300 mg elagolix	Once each evening
Total daily elagolix	600 mg	300 mg morning and 300 mg evening
FDA indication	Heavy menstrual bleeding associated with uterine fibroids	Premenopausal adult women
FDA approval	May 29, 2020	AbbVie

The claimed regimen uses hormonal “add-back” therapy in the morning dose. Estradiol and norethindrone acetate are included to reduce hypoestrogenic effects associated with elagolix, particularly bone mineral density loss. The FDA labeling limits Oriahnn treatment to 24 months because of continued bone-loss risk.[1]

What are the key limitations in claims 1 through 6?

The independent claims require every limitation below:

A premenopausal adult human female patient.
Heavy menstrual bleeding associated with uterine fibroids.
Oral administration.
Elagolix administered as its sodium salt.
A 300 mg elagolix morning dose.
A 300 mg elagolix evening dose.
Estradiol at 1.0 mg in the morning dose.
Norethindrone acetate at 0.5 mg in the morning dose.
Approximately morning and evening administration.
Continued treatment for as long as medically needed.
Less than 8% bone mineral density loss from baseline after 24 weeks.

Claims 1 and 2 are substantively parallel. Claim 1 is written around first and second capsules. Claim 2 is written around first and second doses. Claims 3 through 6 define permissible product configurations.

Claim-by-claim scope

Claim	Scope
1	Method using a morning combination capsule and an evening elagolix capsule
2	Method using a morning combination dose and evening elagolix dose, without requiring a particular dosage form
3	The first dose includes a capsule containing at least estradiol and norethindrone acetate
4	The second dose includes a capsule containing elagolix
5	The first capsule contains elagolix, estradiol, and norethindrone acetate together
6	The second capsule contains elagolix

The claim set therefore covers both the marketed two-capsule arrangement and alternative packaging in which the morning capsule contains all three active ingredients.

How broad is the method-of-treatment protection?

The claims are narrow in dose, indication, patient population and clinical outcome.

A competing product would likely avoid literal infringement if it used:

Less or more than 300 mg elagolix per dose;
Once-daily rather than twice-daily elagolix;
A different estradiol dose;
A different norethindrone acetate dose;
Another progestin;
Another estrogen;
A non-uterine-fibroid indication;
A population other than premenopausal adult women;
A regimen that does not satisfy the claimed bone-mineral-density limitation.

The bone-mineral-density limitation is particularly important. It is an outcome limitation, not merely a formulation limitation. In an infringement case, the patent holder would need to establish that the accused regimen produces the claimed clinical result, potentially through clinical data, prescribing information, pharmacodynamic evidence or other proof.

The phrase “less than 8% following 24 weeks” also creates a potential claim-construction issue. The claim refers to bone mineral density loss from baseline “caused by exposure to elagolix.” The parties could dispute:

The anatomical site used for measuring bone mineral density;
The baseline measurement method;
Whether the result must be shown in every patient or is satisfied by an expected population result;
Whether treatment discontinuation or patient compliance affects the analysis;
Whether the limitation is inherent in the regimen or must be demonstrated empirically.

What formulations are protected by U.S. Patent 11,045,470?

The patent does not require one specific commercial capsule architecture across all claims.

Claim 1 requires:

A first capsule containing elagolix, estradiol and norethindrone acetate; and
A second capsule containing elagolix.

Claim 2 is broader as to dosage form because it refers to “first dose” and “second dose.” Claims 3 to 6 then narrow the possible forms.

The principal covered configurations are:

Configuration	Covered?
Morning capsule containing all three ingredients; evening elagolix capsule	Yes
Morning dose containing separate capsules for elagolix and add-back hormones; evening elagolix capsule	Potentially under claim 2 and claim 3, depending on implementation
Morning combination capsule plus evening tablet containing elagolix	Potentially, if the dosage-form language is satisfied
Once-daily 600 mg elagolix	No literal match to the twice-daily limitation
300 mg elagolix twice daily without estradiol or norethindrone acetate	No literal match
300 mg elagolix twice daily with different add-back doses	No literal match
Elagolix for endometriosis rather than uterine fibroids	Outside the stated indication limitation

The patent therefore protects the regimen more directly than it protects a particular capsule manufacturing process.

When does U.S. Patent 11,045,470 expire?

The patent’s nominal expiration is approximately March 22, 2039, based on the relevant priority framework reflected in the patent family. The effective expiration date may differ if the patent received patent-term adjustment. Patent-term extension is a separate issue and would require a qualifying regulatory basis.

Event	Date or status
Earliest relevant priority	March 22, 2018, according to the patent family chronology
U.S. patent grant	June 29, 2021
Nominal 20-year term endpoint	Approximately March 22, 2039
Patent-term adjustment	Must be calculated from the issued patent record
Patent-term extension	No extension is established by the claim text alone

The patent term is separate from FDA regulatory exclusivity. A patent may remain enforceable after FDA exclusivity ends, and an ANDA applicant may challenge the patent before its expiration through a Paragraph IV certification.

What is the Orange Book status of the Oriahnn regimen?

Oriahnn is a small-molecule drug product, so generic applicants would ordinarily use the ANDA pathway rather than the biosimilar pathway. The relevant Orange Book analysis focuses on listed patents, expiration dates, use codes and FDA dispute procedures.

The key regulatory distinction is:

FDA approval establishes the approved product and labeling.
Orange Book listing identifies patents associated with the approved drug.
A Paragraph IV certification challenges the validity, enforceability or infringement of a listed patent.
Patent litigation under the Hatch-Waxman Act can trigger a 30-month stay of approval, subject to statutory exceptions.

U.S. Patent 11,045,470 is relevant to Oriahnn because its claims track the approved uterine-fibroid regimen. Whether it is currently listed, and under which use code, is an Orange Book record question rather than a matter resolved by the claim language alone.[2]

What Paragraph IV challenges and generic-entry risks exist?

A generic applicant seeking approval for the same labeled regimen could face a Paragraph IV challenge involving the following arguments:

Noninfringement

The applicant could argue that its proposed product does not satisfy one or more limitations, such as:

The morning/evening administration schedule;
The exact estradiol or norethindrone acetate amounts;
The capsule arrangement;
The uterine-fibroid indication;
The premenopausal adult female limitation;
The less-than-8% bone-mineral-density result.

A “skinny label” approach could be considered if the applicant omits the patented uterine-fibroid use. That strategy is fact-dependent because inducement theories can rely on labeling, promotional activity, prescribing practice and the relationship between the patented use and other approved uses.

Invalidity

Potential validity challenges could target:

Written description;
Enablement;
Obviousness;
Definiteness of the bone-mineral-density limitation;
Inherent disclosure of the claimed safety result;
Obviousness of combining elagolix with low-dose estradiol and norethindrone acetate.

The strongest validity analysis would compare the claimed dosing schedule and BMD outcome with prior clinical studies involving elagolix monotherapy, add-back therapy, uterine fibroids and endometriosis.

Patent exhaustion and product substitution

The patent is directed to a method of treatment. A generic product that is chemically equivalent to individual ingredients may not automatically infringe unless the product is marketed, labeled or used in a manner that practices the claimed method. This makes labeling and inducement central to generic-entry risk.

How does this patent compare with other elagolix patent rights?

The elagolix estate has several distinct layers:

Patent layer	Typical subject matter	Commercial function
Compound patents	Elagolix molecule and salts	Base chemical exclusivity
Composition patents	Tablets, capsules and combinations	Product formulation protection
Combination patents	Elagolix with estradiol and progestin	Add-back therapy
Method patents	Fibroids, endometriosis and dosing regimens	Indication and treatment protection
Manufacturing patents	Intermediates, processes and solid forms	Supply-chain and production barriers
Clinical-use patents	Bone-loss reduction and treatment duration	Risk-management and labeling protection

U.S. Patent 11,045,470 is strongest as an indication-and-regimen patent. It is not the principal barrier to manufacturing elagolix as a chemical substance. A generic applicant could potentially design around this patent while still confronting other composition, formulation or compound patents.

What is the patent strength of U.S. Patent 11,045,470?

The patent has meaningful commercial strength against an exact Oriahnn copy because the claims track the branded dosing regimen closely. Its limitations also create several potential weaknesses.

Strength factor	Assessment
Match to approved product	Strong
Dose specificity	Strong against exact copies; creates design-around options
Indication specificity	Strong for uterine-fibroid use; weak outside that indication
Capsule limitations	Moderate; claims include dose-based alternatives
BMD limitation	Potentially valuable but litigation-sensitive
Manufacturing protection	Limited
Chemical composition protection	Limited
Generic label vulnerability	Material
Biosimilar relevance	None; elagolix is a small molecule

The claim set is commercially valuable because a generic version designed to replicate the approved Oriahnn regimen would likely face an infringement case. Its narrower scope means it is less effective against alternative elagolix regimens or products using different add-back hormones.

What litigation and settlement issues affect the patent?

The claim text does not identify a litigation judgment, settlement agreement or licensing transaction. The relevant litigation questions would include:

Whether AbbVie has sued an ANDA filer under 35 U.S.C. §271(e)(2);
Whether the patent is listed for Oriahnn with a method-of-use code;
Whether a 30-month stay was triggered;
Whether the parties entered a launch-date settlement;
Whether any agreement permits an authorized generic;
Whether the FDA has approved a competing elagolix product.

No biosimilar litigation pathway applies. Any challenge would most likely proceed through ANDA litigation, declaratory judgment litigation, or a conventional patent action involving alleged induced infringement.

What licensing deals affect elagolix and Oriahnn?

Elagolix was developed through a collaboration involving AbbVie and Neurocrine Biosciences. Neurocrine disclosed that AbbVie held commercialization rights for elagolix products in the United States and Canada, while Neurocrine retained certain rights in other territories under the collaboration structure.[3]

The commercial rights are distinct from patent ownership. A license can determine who may sue, who may receive royalties and who controls regulatory strategy, while the patent record identifies the formal assignee and inventors.

What generic launch scenarios are most likely?

Exact Oriahnn copy

This is the highest infringement-risk scenario. A product with the same 300 mg morning and evening elagolix schedule, the same add-back hormones and the same uterine-fibroid labeling would closely practice claims 1 and 2.

Skinny-label generic

This may reduce risk if the uterine-fibroid indication and related promotional language are omitted. The strategy remains exposed to induced-infringement arguments if the product is used for the patented method in practice.

Dose or formulation design-around

A competitor could pursue a different elagolix schedule, different add-back regimen or alternative dosage architecture. Such a product may avoid this patent while encountering other patent rights or requiring new clinical and regulatory support.

Post-expiration launch

A generic could launch after the relevant patent and regulatory barriers expire, subject to any other listed patents, pediatric exclusivity, litigation settlement or regulatory requirements.

What is the revenue exposure from this patent?

The patent protects the commercially important fibroid indication for Oriahnn, but it does not cover all elagolix revenue. Orilissa, another elagolix product, is approved for endometriosis-associated pain and uses a different commercial regimen. U.S. Patent 11,045,470 therefore has product-specific exposure centered on Oriahnn rather than the entire elagolix franchise.

Revenue risk increases if:

Oriahnn sales depend heavily on the exact patented regimen;
No clinically practical design-around exists;
The patent remains enforceable through the period of peak generic substitution;
Other Oriahnn patents do not independently block generic entry;
A generic applicant adopts the full uterine-fibroid label.

Revenue risk decreases if a generic can use a skinny label or commercialize an alternative regimen without practicing the claims.

Key Takeaways

U.S. Patent 11,045,470 is a narrow method-of-treatment patent for the Oriahnn regimen.
Claims 1 and 2 require 300 mg elagolix twice daily, with 1.0 mg estradiol and 0.5 mg norethindrone acetate in the morning dose.
The claims apply to premenopausal adult women with heavy menstrual bleeding associated with uterine fibroids.
The regimen must limit bone mineral density loss to less than 8% after 24 weeks.
Claims 3 through 6 cover capsule and dose configurations, including a combined morning capsule and an elagolix-only evening capsule.
The patent does not broadly protect elagolix, all elagolix formulations or all uses of elagolix.
The nominal patent-term endpoint is approximately March 22, 2039, subject to patent-term adjustment and other statutory calculations.
Generic challengers would most likely use noninfringement, obviousness, written-description, enablement or definiteness arguments.
Elagolix is a small molecule, so generic entry would proceed through an ANDA, not a biosimilar application.
The commercial value of the patent is concentrated in the Oriahnn uterine-fibroid indication.

FAQs

Does U.S. Patent 11,045,470 cover Orilissa?

No. The claims are directed to heavy menstrual bleeding associated with uterine fibroids and the Oriahnn dosing regimen. Orilissa is approved for endometriosis-associated pain and is not covered by these claims merely because it contains elagolix.

Can a generic sell elagolix without infringing this patent?

Potentially. A generic that does not use the claimed dose, add-back hormones, uterine-fibroid indication or twice-daily schedule may avoid literal infringement, although other elagolix patents could remain relevant.

Is the less-than-8% bone-loss limitation a major enforcement issue?

Yes. It may help distinguish the claimed regimen from prior art, but it can create disputes over measurement methods, patient populations, causation and whether the result is inherent in every use of the regimen.

Does the patent cover separate morning capsules?

Claim 2 is not limited in the same way as claim 1 to a single combined morning capsule. Claims 3 through 6 define particular capsule arrangements. Separate products must be analyzed against each claim individually.

Does the patent block compounded versions of the regimen?

It can create risk if a compounded product is supplied or promoted for use in a manner that practices the claimed method. Liability would depend on the product, instructions, marketing, dispensing conduct and applicable statutory defenses.

References

U.S. Food and Drug Administration. (2020). Oriahnn (elagolix, estradiol, and norethindrone acetate; elagolix) prescribing information.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
Neurocrine Biosciences, Inc. (2010). Collaboration and license agreement disclosures concerning elagolix.
U.S. Patent No. 11,045,470. (2021). Methods of managing heavy menstrual bleeding associated with uterine fibroids. United States Patent and Trademark Office.
35 U.S.C. §§ 271(e)(2), 282, 284, 156. (2024). United States Code.

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	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes	11,045,470	⤷ Start Trial				MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)	⤷ 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: 11,045,470

Which drugs does patent 11,045,470 protect, and when does it expire?

Summary for Patent: 11,045,470