United States Patent 10,940,153: Scope, Claims, and US Landscape for Oral Meloxicam/SBEβCD/Bicarbonate plus Rizatriptan in Migraine
What does US 10,940,153 claim in operational terms?
US 10,940,153 covers a specific oral treatment method for acute migraine with photophobia, where the clinician selects a migraine patient based on inadequate prior treatment response and presence of photophobia, then administers a multi-component oral dosage form containing:
- Meloxicam–SBEβCD complex
- Bicarbonate (e.g., sodium bicarbonate)
- Rizatriptan (including salt forms such as rizatriptan benzoate)
The therapeutic endpoint in the claim language is reduction in photophobia lasting at least 24 hours after administration. The formulation scope is further constrained by tight compositional ranges, and in dependent claims by pharmacokinetic differentiation (shorter Tmax for meloxicam versus a defined reference product).
The claim set therefore reads as a formulation-method hybrid: it ties (i) patient selection, (ii) the exact composition, and (iii) at least one pharmacologic outcome (photophobia reduction at 24 hours), with additional fallbacks via Tmax.
Claim scope: what must be present for infringement?
1) Patient population and treatment timing
The independent claim (claim 1) requires all of the following:
- Human migraine patient
- History of inadequate response to prior migraine treatments
- History of photophobia accompanying migraine
- Acute migraine pain with photophobia at the time of dosing
- Oral administration of the claimed dosage form
- Photophobia reduction lasting at least 24 hours
Any product that is administered outside that clinical context (no acute photophobia at dosing, or no inadequate prior response, or no ≥24-hour photophobia effect) does not track claim 1.
2) Dosage form composition (all three components)
Claim 1 requires the dosage form to contain, as a combination:
- Complex of meloxicam with SBEβCD
- Bicarbonate
- Rizatriptan
Each element is material:
- If the product contains rizatriptan plus meloxicam but not SBEβCD (or not as the meloxicam complex), it falls outside the claim language.
- If it contains meloxicam–SBEβCD plus rizatriptan but no bicarbonate, it falls outside the claim language.
- If it contains meloxicam–SBEβCD plus bicarbonate but no rizatriptan, it falls outside.
3) Pharmacokinetic and formulation-structure constraints (dependent claims)
Dependent claims add extra “design-in” constraints:
- Solid oral dosage form with shorter meloxicam Tmax
- Dependent claim 6: shorter Tmax versus a “reference dosage form” that
1) contains the same meloxicam amount,
2) does not contain SBEβCD, and
3) does not contain bicarbonate.
- Dependent claim 7: “shown to have faster time to therapeutic plasma concentration.”
These are not standalone composition requirements; they can function as additional infringement hooks for commercial products designed to meet those PK outcomes.
Independent claim 1: what is the core protected invention?
Claim 1, in compressed form:
A method of treating migraine with oral administration of a dosage form containing:
- meloxicam–SBEβCD complex
- bicarbonate
- rizatriptan
to a patient who:
- has inadequate response to prior migraine treatments
- has photophobia accompanying migraine
- is in an acute migraine attack with photophobia at dosing
with an expected clinical effect:
- reduction in photophobia lasting at least 24 hours after dosing.
This is the “spine” claim. All dependent claims narrow within the same framework.
Dependent claim map: which parameters narrow the formulation?
A. Patient selection narrowing
- Claim 2: dosage is for a patient selected for history of photophobia accompanying migraine.
B. Bicarbonate amount and identity
- Claim 3: dosage form contains 400 mg to 600 mg bicarbonate.
- Claim 23: bicarbonate comprises sodium bicarbonate.
- Claim 24: dosage form contains 500 mg sodium bicarbonate.
These claims tighten the formulation to a specific bicarbonate dosing band.
C. Meloxicam amount bands (multiple fallbacks)
- Claim 4: 5 mg to 50 mg meloxicam.
- Claim 11: 10 mg to 30 mg meloxicam.
- Claim 12: about 20 mg meloxicam.
- Claim 13: about 15 mg meloxicam.
This creates multiple defensible “commercial landing zones” for different product strengths.
D. SBEβCD amount bands and substitution pattern
- Claim 5: 50 mg to 200 mg SBEβCD.
- Claim 15: 50 mg to 150 mg SBEβCD.
- Claim 16: about 100 mg SBEβCD.
- Claim 14: SBEβCD has about 6 to about 7 sulfobutyl ether groups per β-cyclodextrin molecule.
The substitution pattern limitation (6 to 7 sulfobutyl ether groups) is a meaningful narrowing factor: a manufacturer using a differently substituted SBEβCD variant can fall outside claim 14 while still using “SBEβCD” in a generic sense.
E. SBEβCD:meloxicam ratio bands
- Claim 17: molar ratio 0.5 to 2.
- Claim 18: molar ratio 0.8 to 1.2.
- Claim 19: molar ratio about 1.
These claims protect a stoichiometric design for the complex.
F. Rizatriptan dose bands and salt form
- Claim 8: 1 mg to 50 mg rizatriptan (free base basis).
- Claim 9: salt form with molar equivalent of about 10 mg rizatriptan free base.
- Claim 10: rizatriptan is rizatriptan benzoate.
- Claim 20: dosage form contains about 10 mg to about 40 mg meloxicam and about 5 mg to about 50 mg rizatriptan.
- Claim 21/22: SBEβCD to rizatriptan weight ratio:
- Claim 21: 1 to 100
- Claim 22: about 10
The inclusion of rizatriptan benzoate is an explicit salt-form lock.
G. PK-triggered differentiation via shorter Tmax
- Claim 6: solid oral dosage form has shorter Tmax of meloxicam in humans than a defined reference formulation (same meloxicam amount; no SBEβCD; no bicarbonate).
- Claim 7: shown to have faster time to therapeutic plasma concentration vs reference.
- Claim 25: median Tmax < 90 minutes in fasted subjects.
- Claim 26: median Tmax < 2 hours in fasted subjects.
These claims provide alternative enforcement routes even if a defendant contests clinical endpoint evidence; they can also incentivize competitors to generate comparative PK to map into or out of the claim-defined performance.
H. Repetition of narrowing in claim 27–30
- Claims 27–30 repeat the claim 3/4/5 ranges and include the same “shorter Tmax versus reference” language as claims 6/30.
This redundancy suggests the claim set is built to ensure that key parameter bands remain covered even when upstream claim 1 elements are contested.
What formulation variants fall inside versus outside? (Practical scope)
Inside the claim set (must match all relevant required elements)
- Oral solid dosage containing:
- meloxicam in a complex with SBEβCD,
- a bicarbonate component (e.g., sodium bicarbonate) at a defined band,
- rizatriptan (including benzoate, or equivalent molar salt basis per dependent claims),
- dosed to a migraine patient with photophobia and inadequate prior response,
- with an expected photophobia reduction lasting ≥24 hours.
- Products designed to meet dependent claims can further match:
- meloxicam Tmax acceleration (median <90 minutes or <2 hours in fasted),
- specific SBEβCD amounts (50–200 mg; 50–150 mg; ~100 mg),
- specific meloxicam strengths (about 15 mg, about 20 mg, or 10–30 mg band),
- specific SBEβCD substitution (6–7 sulfobutyl ether groups).
Outside the claim set (common design-outs)
- Formulations that exclude bicarbonate.
- Formulations that use SBEβCD but without establishing the meloxicam–SBEβCD complex as required by the claim language.
- Rizatriptan forms that are not within the required salt identity or molar equivalent ranges in the dependent claims (note: claim 1 covers rizatriptan generally; dependent claims lock the salt form).
- Products that do not treat patients with the required selection criteria (inadequate prior response; photophobia history; acute photophobia at dosing).
- Products that do not produce the claimed clinical outcome (photophobia reduction ≥24 hours), which matters most for claim 1.
How does this sit in the US patent landscape?
The practical landscape is framed by three technology layers that can be infringed or designed around independently:
-
Combination therapy and method-of-treatment claims
- This patent is a method claim tied to migraine, photophobia, and acute dosing.
- That narrows enforceability but also raises the bar for a defendant: they must be practicing the method on the claimed patient population, and produce the claimed photophobia endpoint.
-
Oral formulation platform
- The meloxicam–SBEβCD complex plus bicarbonate is a formulation scaffold aimed at improving oral exposure of meloxicam (Tmax acceleration).
- Dependent claims with PK thresholds can capture products even if clinical endpoint evidence is contested, assuming the PK comparisons are satisfied.
-
Rizatriptan salt and dose integration
- Rizatriptan inclusion, plus salt specification (rizatriptan benzoate) in dependent claims, creates clear design constraints for competitors who may attempt to swap salts.
Claim-level defensibility implications
- The independent claim’s clinical endpoint (photophobia reduction ≥24 hours) is a strong differentiator if supported by trial data, but it is also a litigation focal point.
- The dependent PK claims (median Tmax thresholds) can provide alternative proof and can support “formulation differentiation” positions in enforcement or validity challenges.
- The SBEβCD substitution constraint (6–7 sulfobutyl ether groups) is a potential escape route for competitors using different SBEβCD specs.
Competitive freedom-to-operate map (what businesses will test)
Competitors likely to probe three axes:
-
Bicarbonate presence and dose
- If a competitor excludes bicarbonate or changes dose outside 400–600 mg (or 500 mg sodium bicarbonate), they avoid dependent claims 3/24/27 but could still fall under claim 1 if bicarbonate is still present (claim 1 only requires bicarbonate, not the band).
-
SBEβCD variant and substitution
- Attempt to use a different degree of sulfobutylation than 6–7 per cyclodextrin (claim 14).
-
PK outcomes for meloxicam
- If median Tmax does not satisfy <90 minutes or <2 hours in fasted subjects relative to the reference formulation, competitors can attempt to avoid dependent claims 25/26 while still possibly remaining within claim 1.
Where generic substitution risk concentrates
- Generics that include the full three-component formulation and are prescribed for the acute photophobia population at the appropriate timing could face claim 1 risk.
- Partial generics or reformulations aimed at removing bicarbonate (or altering SBEβCD identity) are higher-likelihood design-arounds.
US 10,940,153 claim matrix (parameter-by-parameter)
| Element |
Independent / Dependent |
Range or requirement (as claimed) |
| Migraine method; acute pain + photophobia at dosing |
Claim 1 |
Patient has acute migraine pain with photophobia at administration; photophobia reduction lasts ≥24 hours |
| Prior inadequate response |
Claim 1 |
Patient has history of inadequate response to prior migraine treatments |
| Photophobia history selection |
Claim 1, 2 |
History of photophobia accompanying migraine |
| Meloxicam–SBEβCD complex |
Claim 1 |
Complex of meloxicam with SBEβCD |
| Bicarbonate |
Claim 1 |
Bicarbonate present; sodium bicarbonate in dependent claims |
| Bicarbonate amount |
Claim 3 |
400 mg to 600 mg |
| Sodium bicarbonate amount |
Claim 24 |
500 mg |
| Meloxicam amount |
Claim 4 |
5 mg to 50 mg |
| Meloxicam amount band |
Claim 11 |
10 mg to 30 mg |
| Meloxicam specific levels |
Claim 12, 13 |
about 20 mg; about 15 mg |
| SBEβCD amount |
Claim 5 |
50 mg to 200 mg |
| SBEβCD amount tighter |
Claim 15 |
50 mg to 150 mg |
| SBEβCD specific level |
Claim 16 |
about 100 mg |
| SBEβCD substitution level |
Claim 14 |
about 6 to about 7 sulfobutyl ether groups per β-cyclodextrin |
| SBEβCD:meloxicam molar ratio |
Claim 17-19 |
0.5–2; 0.8–1.2; about 1 |
| Rizatriptan dose |
Claim 8 |
1 mg to 50 mg (free base basis) |
| Rizatriptan salt equivalent |
Claim 9 |
molar equivalent of about 10 mg free base |
| Rizatriptan salt |
Claim 10 |
rizatriptan benzoate |
| SBEβCD:rizatriptan weight ratio |
Claim 21-22 |
1–100; about 10 |
| Solid oral form with faster meloxicam Tmax |
Claim 6 |
Shorter Tmax vs reference (same meloxicam; no SBEβCD; no bicarbonate) |
| Faster therapeutic time |
Claim 7 |
Faster time to therapeutic plasma concentration vs reference |
| Median Tmax threshold (fasted) |
Claim 25 |
<90 minutes |
| Median Tmax threshold (fasted) |
Claim 26 |
<2 hours |
Key Takeaways
- US 10,940,153 protects a method of treating acute migraine with photophobia using an oral dosage form that combines meloxicam–SBEβCD, bicarbonate, and rizatriptan, with a required outcome of photophobia reduction lasting at least 24 hours.
- The independent claim is anchored on patient selection (inadequate prior response; photophobia history; acute photophobia at dosing) plus the three-component oral formulation.
- Dependent claims sharpen enforceability through precise formulation parameters (bicarbonate dose band; meloxicam and SBEβCD ranges; SBEβCD substitution level; rizatriptan salt) and through pharmacokinetic performance (meloxicam median Tmax thresholds in fasted subjects vs a specified reference).
- For landscape and design-around, the highest-impact variables are presence and dose of bicarbonate, the identity/spec of SBEβCD (substitution level), and whether the product achieves the claimed meloxicam Tmax acceleration.
FAQs
1) Does claim 1 require a specific meloxicam dose?
Claim 1 requires meloxicam in the meloxicam–SBEβCD complex plus rizatriptan and bicarbonate, but it does not fix meloxicam to a numeric range. Numeric meloxicam ranges appear in dependent claims (e.g., 5–50 mg; 10–30 mg; about 15 mg; about 20 mg).
2) Is bicarbonate mandatory for infringement of claim 1?
Yes. Claim 1 requires a dosage form comprising a combination that includes bicarbonate.
3) Is rizatriptan benzoate required?
No for claim 1. Claim 1 requires rizatriptan generally. Rizatriptan benzoate is specified in dependent claim 10, which narrows that particular dependent path.
4) What performance metric is used to distinguish formulations in dependent claims?
Dependent claim 6 and related claims use meloxicam Tmax (with fasted median thresholds in claims 25 and 26) versus a defined reference formulation lacking both SBEβCD and bicarbonate.
5) What clinical endpoint is tied to the method claim?
Claim 1 requires reduction in photophobia that lasts at least 24 hours after oral administration.
References
[1] United States Patent No. 10,940,153.
