What is US Drug Patent 11,787,820’s Scope and How Broad Are Its Claims?

US Patent 11,787,820 is a method-of-treatment patent directed to treating sex hormone-dependent diseases using soft gelatin capsules that contain:

Compound A (including anhydrate crystalline form embodiments), and
A defined lipid-based solubilizer system (selected from specific excipients), and
An antioxidant system (selected from specific antioxidants), with optional and constrained addition of an emulsifier (notably glyceryl monooleate), plus defined amount and concentration ranges.

The claims are structured so that infringement does not hinge on a single dosing parameter or a single excipient. It hinges on meeting the combination of: 1) the indication (one of the listed sex hormone-dependent diseases), and
2) the dosage form (soft gelatin capsule), and
3) the formulation excipient selections, and
4) the form/identity constraints on Compound A for certain claims, plus
5) multiple w/w range locks (for solubilizer and antioxidant components), plus
6) defined compound loading and daily dosing in dependent claims.

The practical scope therefore has two layers:

Core capture: any administration of a soft gelatin capsule meeting the claim’s excipient/antioxidant selection and containing Compound A to treat the listed diseases.
Narrow capture: additional dependent claims tighten the infringement perimeter via crystalline anhydrate form definition, and specific w/w composition and mg/day dosing.

What Does the Independent Claim Cover (Claim 1 and Claim 31)?

Claim 1: What is the baseline coverage?

Claim 1 covers a method of treating any of the listed diseases by administering to a human one or more soft gelatin capsules comprising:

(a) Compound A or pharmaceutically acceptable salt
(b) at least one solubilizer selected from:

caprylocaproyl polyoxyl-8 glycerides
glycerol monocaprylocaprate
polyoxyl 35 castor oil
polysorbate 80
mixtures thereof
(c) at least one antioxidant selected from:
dl-alpha-tocopherol
butylated hydroxytoluene (BHT)
butylated hydroxyanisole (BHA)
mixtures thereof

Indications explicitly captured (sex hormone-dependent diseases):

vasomotor symptoms (VMS)
endometriosis
uterine fibroid tumor
heavy menstrual bleeding
polycystic ovary syndrome (PCOS)

Key breadth point: Claim 1 does not constrain:

the exact mg dose or w/w concentration of Compound A, or
the exact ratio among solubilizers, or
the exact ratio among antioxidants,
as long as the capsule contains the required selection-set.

Claim 31: What is the tighter composition lock?

Claim 31 is another method claim (independent in structure) that restricts the soft gelatin capsule to a specific formulation featuring all of:

Compound A: 5% w/w to 10% w/w
glycerol monocaprylocaprate: 20% w/w to 65% w/w
caprylocaproyl polyoxyl-8 glycerides: 7% w/w to 13% w/w
polysorbate 80: 7% w/w to 13% w/w
dl-alpha-tocopherol: 0.5% w/w to 1% w/w
glyceryl monooleate: present (no explicit w/w bound in Claim 31 itself)

This claim is narrower than Claim 1 because it requires a specific intersection of solubilizers and antioxidant, not merely “at least one.”

How Many Indications Are Claimed, and Do They Affect Enforcement?

The patent’s indication coverage is broad at the claim level because it lists five disease categories in the independent claim(s). Dependent claims then anchor enforcement to the same disease list but narrow which disease is being treated.

Disease list (same across claim 1 and claim 31 and dependent claims 4-8): 1) VMS
2) endometriosis
3) uterine fibroid tumor
4) heavy menstrual bleeding
5) PCOS

Implication for landscape: A competitor using the formulation for an indication outside that list may avoid method-of-treatment claim coverage. But if the product is used on-label or marketed for one of these indications, the claims become directly relevant.

What Is Claimed About Compound A’s Solid Form (Claim 2 and Claim 3)?

Claim 2: crystalline anhydrate

Claim 2 states: Compound A is in a crystalline anhydrate form.

Claim 3: crystalline anhydrate Form 1 with XRD-defined peaks

Claim 3 further constrains Compound A to crystalline anhydrate Form 1, defined by a specific XRD peak list:

Peaks at 2θ (degrees):

4.3 ± 0.1
7.9 ± 0.1
9.8 ± 0.1
10.7 ± 0.1
10.8 ± 0.1
13.3 ± 0.1
14.0 ± 0.1
15.1 ± 0.1

Corresponding d-spacing (Å):

20.4
11.1
9.0
8.3
8.2
6.6
6.3
5.9

Scope effect:

If a generic or alternative formulation uses a different solid form (not crystalline anhydrate or not anhydrate Form 1), it may avoid these dependent claim constraints.
Claim 1 itself does not require the anhydrate Form 1; it only requires Compound A generally (or a salt). Claim 2 and 3 create narrower “fallback” positions for the patentee.

What Soft-Gel Formulation Elements Drive Claim Validity and Claim Differentiation?

The claims tightly define a formulation system built from:

a lipid-solubilizer system (solubilizers),
an optional/required emulsifier (glyceryl monooleate in certain dependent claims),
an antioxidant that is specifically enumerated, and
concentration/w/w ranges that scale infringement risk.

Solubilizer selection set (Claim 1) vs full matrix (Claim 31)

Claim 1 solubilizers allowed (at least one):

caprylocaproyl polyoxyl-8 glycerides
glycerol monocaprylocaprate
polyoxyl 35 castor oil
polysorbate 80
mixtures

Claim 31 requires:

glycerol monocaprylocaprate
caprylocaproyl polyoxyl-8 glycerides
polysorbate 80
(no polyoxyl 35 castor oil recited in Claim 31 composition)

Antioxidant selection set (Claim 1) vs constrained antioxidant (Claim 31)

Claim 1 antioxidants allowed (at least one):

dl-alpha-tocopherol
BHT
BHA
mixtures

Claim 31 requires dl-alpha-tocopherol at 0.5% to 1% w/w.

Emulsifier: glyceryl monooleate

Claim 10 introduces optional requirement by specifying at least one emulsifier selected from glyceryl monooleate or Miglyol 812 (or mixture).
Claim 17 pins the emulsifier to glyceryl monooleate.
Claim 20-21 describe capsule embodiments where glyceryl monooleate is explicitly present alongside the full solubilizer + tocopherol system.
Claim 31 includes glyceryl monooleate as part of the full composition.

How Do the Dependent Claims Narrow or Expand the Infringement Footprint?

Compound loading and daily dosing

Dependent claims constrain dose in mg and daily dose:

Claim 37-38: one soft gelatin capsule contains Compound A 1 mg to 250 mg
Claim 39-41: daily dose
- Claim 39: daily dose 100 mg to 160 mg
- Claim 40: daily dose 120 mg
- Claim 41: two capsules, 60 mg each

These do not affect Claim 1’s baseline capture unless an accused product must also meet the dependent dosing constraints (which it would, if the dosage design matches those numbers). But they matter for enforcement strategy and for design-around analysis.

Compound concentration ranges (w/w)

Claim 11: Compound A 10 mg to 80 mg (presented as “amount,” not w/w in Claim 11)
Claim 13: Compound A 0.8% to 15% w/w or 5% to 10% w/w

Claim 31 specifically selects 5% to 10% w/w, aligning with one of Claim 13’s subranges.

Solubilizer and emulsifier concentration ranges

Where the claims become most “engineerable” is in the w/w ranges:

glycerol monocaprylocaprate (Claims 22-23):

20% w/w to 65% w/w

caprylocaproyl polyoxyl-8 glycerides (Claims 24-25):

7% w/w to 13% w/w

polysorbate 80 (Claims 26-27):

7% w/w to 13% w/w

glyceryl monooleate (Claim 28):

15% w/w to 60% w/w

dl-alpha-tocopherol (Claims 29-30):

0.05% w/w to 1.5% w/w
Claim 31 constrains this more tightly to 0.5% w/w to 1% w/w

Specific combination embodiments (Claims 20-21)

The claims include explicit composition snapshots:

Claim 20: Compound A + glycerol monocaprylocaprate + caprylocaproyl polyoxyl-8 glycerides + polysorbate 80 + dl-alpha-tocopherol
Claim 21: same as Claim 20 plus glyceryl monooleate

These are relevant because an accused formulation that uses the same excipient set and typical solubilizer system could land quickly on dependent claim scope.

What Does Claim 32 Say About the Capsule Preparation Process?

Claim 32 includes a preparation method constraint:

each soft gel capsule is prepared by a method comprising adding Compound A to a mixture comprising:
- 15% w/w to 60% w/w glyceryl monooleate, and/or
- glycerol monocaprylocaprate,
- caprylocaproyl polyoxyl-8 glycerides,
- polysorbate 80,
- dl-alpha-tocopherol, or any combination thereof.

This is a formulation process anchor. In practice, it adds a second hook for infringement assertions if product manufacturing statements or internal batch recipes track the claim language.

What Is the Likely Patent “Landscape Shape” Around This Publication?

Based on the claim set provided, US 11,787,820 is best understood as a formulation-and-method protection layer covering:

an identified active (Compound A) in a particular crystalline anhydrate form (at least in dependent claims), and
a soft-gel excipient architecture designed to solubilize and stabilize the drug (solubilizers + antioxidant + optional emulsifier).

Landscape implications for competitors

1) Liquid/solubilizer design-around is partially constrained.
Claim 1 requires at least one solubilizer from a defined list. Claim 31 requires a particular trio plus tocopherol. This makes “just swap solubilizer” strategies risky if the replacement still falls within the selection sets.

2) Antioxidant substitution is relevant.
Claim 1 allows BHT/BHA/tocopherol. But Claim 31 forces dl-alpha-tocopherol. A competitor could target that by using a non-tocopherol antioxidant, but then it would avoid only those dependent claim embodiments, not necessarily Claim 1.

3) Solid form strategy can reduce exposure to claims 2-3, not claim 1.
If Compound A is not in crystalline anhydrate Form 1, dependent claims 2 and 3 may be avoided, but claim 1 still covers Compound A generally. This narrows the value of a “solid-form only” workaround.

4) Dose design-around helps for dependent dosing claims, not the independent formulation claims.
A competitor could pick dosing outside 100-160 mg/day, 120 mg/day, or the 60 mg two-capsule scenario, potentially weakening enforcement on those dependent claims. But claim 1/31 still remain.

What the claim structure suggests about prosecution and continuation

The presence of multiple w/w range-dependent claims and an XRD-defined form suggests:
- the patentee refined boundaries around formulation performance and stability, and
- the crystalline anhydrate Form 1 got a specific measurement-based claim fallback.

That typically indicates the patent is intended to withstand partial design-around by allowing enforcement on different combinations (broad Claim 1) and by locking particular high-value compositions (Claim 31 and later dependent claims).

Claim-by-Claim Scope Map (Operational View)

A. Indication coverage

Disease category	Captured in independent language	Narrowed in dependents
VMS	Yes	Claim 4
Endometriosis	Yes	Claim 5
Uterine fibroid tumor	Yes	Claim 6
Heavy menstrual bleeding	Yes	Claim 7
PCOS	Yes	Claim 8

B. Formulation core

Component requirement	Claim 1	Claim 31
Dosage form	Soft gelatin capsule	Soft gelatin capsule
Active	Compound A or salt	Compound A at 5-10% w/w
Solubilizers	At least one from listed set	Requires glycerol monocaprylocaprate (20-65%), caprylocaproyl polyoxyl-8 glycerides (7-13%), polysorbate 80 (7-13%)
Antioxidant	At least one from listed set	Requires dl-alpha-tocopherol (0.5-1% w/w)
Emulsifier	Optional via dependents (glyceryl monooleate or Miglyol 812)	Requires glyceryl monooleate

C. Solid form

Feature	Claim 1	Claim 2	Claim 3
Crystalline anhydrate	Not required	Required	Required
Form 1 XRD peak definition	Not required	No	Yes (2θ peak list)

D. Composition quantitative locks

Variable	Dependent claim range
Compound A concentration	Claim 13: 0.8-15% w/w or 5-10% w/w
Compound A amount per capsule	Claim 11/12: 10-80 mg; Claim 37/38: 1-250 mg (single capsule)
Compound daily dose	Claim 39-41: 100-160 mg; 120 mg; or two capsules at 60 mg each
glycerol monocaprylocaprate	Claim 22-23: 20-65% w/w; Claim 34: 30-40% w/w
caprylocaproyl polyoxyl-8 glycerides	Claim 24-25: 7-13% w/w
polysorbate 80	Claim 26-27: 7-13% w/w
glyceryl monooleate	Claim 28: 15-60% w/w; Claim 33: same; Claim 32 process recites 15-60% w/w
dl-alpha-tocopherol	Claim 29-30: 0.05-1.5% w/w; Claim 31: 0.5-1% w/w

Key Takeaways

US 11,787,820 protects methods of treating five sex hormone-dependent diseases using soft gelatin capsules with Compound A plus a defined solubilizer selection and defined antioxidant selection.
Claim 1 is the broadest formulation capture, requiring only “at least one” solubilizer and “at least one” antioxidant from enumerated lists.
Claim 31 is the most composition-specific capture, requiring a full excipient stack with constrained w/w ranges and dl-alpha-tocopherol plus glyceryl monooleate.
Solid form constraints appear in dependent claims: anhydrate (Claim 2) and XRD-defined Form 1 (Claim 3).
Dosing constraints in dependent claims (mg per capsule and mg/day schedules) add additional enforcement hooks, but do not eliminate the broad independent formulation coverage.

FAQs

1) Does Claim 1 require a specific concentration of Compound A?
No. Claim 1 requires Compound A (or salt) and the presence of solubilizer and antioxidant selections in the soft gelatin capsule, without a mandatory w/w or mg range.

2) Is dl-alpha-tocopherol mandatory in all embodiments?
No. Claim 1 allows any of dl-alpha-tocopherol, BHT, or BHA. dl-alpha-tocopherol becomes mandatory in the tighter composition embodiment(s), including Claim 31.

3) Can a different crystalline form avoid infringement?
It may avoid dependent claims tied to anhydrate Form 1 XRD (Claims 2-3), but it does not remove coverage of Claim 1 unless the product also avoids Claim 1’s broader requirements.

4) Is glyceryl monooleate required for coverage?
It is not required by Claim 1 as an absolute rule, but it is required in specific dependent and composition-specific embodiments (including Claim 31 and Claims 17, 21, 28, 33).

5) How do competitors design around the formulation?
The claims are most sensitive to meeting the enumerated solubilizer selection and, for Claim 31-type embodiments, the full required excipient stack and w/w ranges. Changing the antioxidant away from tocopherol can help only against embodiments that require dl-alpha-tocopherol.

References

[1] US Patent 11,787,820 (claims text provided in prompt).

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bayer Hlthcare	LYNKUET	elinzanetant	CAPSULE;ORAL	219469-001	Oct 24, 2025		RX	Yes	Yes	11,787,820	⤷ Start Trial				TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS DUE TO MENOPAUSE	⤷ 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
Australia	2019233606	⤷ Start Trial
Brazil	112020017388	⤷ Start Trial
Canada	3092238	⤷ Start Trial
Chile	2020002350	⤷ Start Trial
China	112292132	⤷ Start Trial
China	119950513	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,787,820

Which drugs does patent 11,787,820 protect, and when does it expire?

Summary for Patent: 11,787,820