United States Patent 11,364,224 (Sumatriptan SC Autoinjector) Scope, Claim Breakdown, and Patent Landscape

Executive summary: US 11,364,224 claims a subcutaneous (SC) sumatriptan succinate acute migraine treatment delivered in a 0.5 mL autoinjector or injection, with tightly defined formulation parameters (sodium chloride amount, osmolality 275 to 315 mOsm/kg, pH 4.2 to 5.3) and tightly defined pharmacokinetic exposure windows (ranges for Cmax, AUC0-2, AUC0-inf). The claims are written to capture both autoinjector delivery and direct SC injection, and they limit dosing to a 4-times-a-day maximum. The enforceable scope is therefore largely driven by whether an accused product matches the specific composition and PK exposure characteristics, not merely “SC sumatriptan.”

What does US 11,364,224 claim for acute migraine with sumatriptan succinate delivered subcutaneously?

Direct answer (claim essence): US 11,364,224 is directed to a method of treating acute migraine in a patient by SC administration of a defined aqueous formulation of sumatriptan succinate (4.2 mg in 0.5 mL) with sodium chloride within a specified mass range, with osmolality 275 to 315 mOsm/kg and pH 4.2 to 5.3, and producing specified system exposure plasma PK ranges after administration. Independent claim 1 requires autoinjector delivery; independent claim 8 covers SC injection and includes the same formulation and PK windows.

Claim 1 (autoinjector) scope

Claim 1 requires all of the following elements:

Medical indication: treating acute migraine.
Route and device: subcutaneous administration by autoinjector.
Dosage form/composition:
- aqueous solution
- 4.2 mg sumatriptan succinate per dose
- sodium chloride amount in 4.15 mg to 4.2 mg per 0.5 mL total volume
- total volume 0.5 mL
Formulation physical chemistry:
- osmolality 275 to 315 mOsm/kg
PK exposure characteristics: administration results in at least one of:
- Cmax ~ 35 to 57 ng/mL
- AUC0-2 ~ 30 to 50 ng·hr/mL
- AUC0-inf ~ 43 to 70 ng·hr/mL
Dependent claims then narrow to pH, migraine subtypes, specific autoinjector size/type, and dosing frequency.

Claim 8 (injection) scope

Claim 8 parallels claim 1 but replaces autoinjector with subcutaneously injecting the composition and keeps:

acute migraine treatment
4.2 mg sumatriptan succinate / 0.5 mL
sodium chloride 4.15 to 4.2 mg
osmolality 275 to 315 mOsm/kg
at least one PK window (same Cmax/AUC ranges)
dependent claims add pH, migraine with aura/without aura, and then bring back autoinjector in claim 13.

How do the formulation limitations (NaCl, osmolality, pH) define infringement risk under US 11,364,224?

Direct answer: The claims use numerical formulation parameters as structural constraints. An accused product that uses SC sumatriptan succinate but differs in osmolality or pH outside the claimed ranges (275–315 mOsm/kg and pH ~4.2–5.3) is harder to capture unless the relevant dependent claim is asserted or doctrine of equivalents is pursued. Independence already requires osmolality. P≤5.3 only appears in dependent claims.

Key formulation numbers

Sumatriptan succinate amount: 4.2 mg
Total volume: 0.5 mL
Sodium chloride range: 4.15 mg to 4.2 mg
Osmolality: 275 to 315 mOsm/kg (required in claims 1 and 8)
pH: ~4.2 to 5.3 (required in claims 2 and 9)

Why osmolality and pH matter

Osmolality is included as an explicit independent-claim limitation. That means claim 1/8 are not satisfied by “SC sumatriptan succinate” generally; they require a composition that yields an osmolality within a relatively broad but still bounded band.
pH is not in independent claims, but it becomes required in dependent claims. Enforcement strategy typically targets the narrowest applicable claims if the accused formulation matches.
The NaCl range is unusually tight for a “salt” excipient limitation. Even if an accused product uses different tonicity agents, different NaCl concentration, or substitutes excipients affecting osmolality, the accused composition may fail the independent limitations.

How do the pharmacokinetic exposure windows (Cmax and AUC) control claim scope and design-around?

Direct answer: Claims 1 and 8 require that the administered composition results in at least one of three PK exposure ranges. This turns the claims into performance-based limitations: infringement depends on measured exposure in the patient population/individuals for the claimed administration.

PK parameters in the claims

At least one of the following must fall within the claimed ranges:

Cmax: about 35 to 57 ng/mL
AUC0-2: about 30 to 50 ng·hr/mL
AUC0-inf: about 43 to 70 ng·hr/mL

Practical consequences

The “at least one” structure reduces the need to match all three windows. If an accused product misses Cmax but lands AUC0-2 or AUC0-inf inside range, it could still meet the limitation.
Conversely, a design-around can aim to push all of Cmax, AUC0-2, and AUC0-inf outside the windows, which may be achieved via changes that alter absorption kinetics (formulation tonicity, viscosity, injection parameters, autoinjector needle characteristics).
Litigation often becomes a PK evidence dispute: which study conditions, which subjects, and how “about” is treated for the claimed ranges.

What device limitations are included: does the patent require an autoinjector in the independent claim?

Direct answer: Yes for claim 1, no for claim 8. Claim 1 requires SC by autoinjector. Claim 8 covers SC injection without requiring an autoinjector. Dependent claim 13 then ties injection to autoinjector use.

Autoinjector limitations

Claim 1: subcutaneous administration by autoinjector
Claim 6: autoinjector comprises a 0.5 mL prefilled, ready-to-use, single dose, disposable auto-injector
Claim 13: claim 8 method includes injecting using an autoinjector
Claim 14: same 0.5 mL prefilled disposable single-dose autoinjector limitation

Infringement mapping

A product delivered by manual syringe SC injection could potentially fall under claim 8 (if composition and PK match).
A product delivered by autoinjector would still fall under claim 1 if all conditions are met, and under claim 13/14 if asserting dependent claims against an injected product.

How do the claims treat migraine subtype and dosing frequency?

Direct answer: Aura vs no aura are handled through dependent claims tied to claim 3/10. Maximum dosing frequency is included as a dependent limitation.

Migraine subtype dependencies

Claim 3 depends on claim 1: acute migraine with aura
Claim 5 depends on claim 3: acute migraine without aura
Claim 10 depends on claim 8: acute migraine
Claims 11 and 12:
- claim 11: acute migraine with aura
- claim 12: acute migraine without aura

Frequency limitation

Claim 7: maximum recommended frequency not more than four times a day
Claim 15 repeats the same limit for claim 8-based methods

This is a narrow behavioral limitation. If a product label or clinician instructions align with typical sumatriptan use (commonly limited dosing intervals), it may be difficult for an accused method to escape if other claim elements are met.

What is the enforceable claim scope: what does US 11,364,224 cover and what is likely outside it?

Direct answer: The patent is positioned at the intersection of (1) SC sumatriptan succinate in a 0.5 mL dose, (2) specific excipient/tonicity/osmolality characteristics, (3) a PK absorption profile window, and (4) device delivery (autoinjector in claim 1; not required in claim 8).

Likely within scope

SC sumatriptan succinate delivered as 0.5 mL with 4.2 mg dose and osmolality 275–315 mOsm/kg
Formulations matching NaCl mass and producing at least one of the claimed PK ranges
Autoinjector products matching the defined formulation and PK characteristics

Likely outside (by claim construction)

Products with correct active and dose but osmolality outside 275–315 mOsm/kg
Products with correct route but without the defined PK exposure window (all three parameters outside the claimed ranges)
Formulations with correct osmolality but pH outside 4.2–5.3 would not meet the dependent pH claims (but could still meet independent claims 1/8)

Key litigation pivot

The enforcement narrative likely centers on whether the accused composition yields the claimed osmolality and PK exposure under relevant administration conditions.

How many independent and dependent claim “attack surfaces” exist in US 11,364,224?

Direct answer: The patent includes two independent method claims (1 and 8) with multiple dependent claim layers that add narrower requirements on pH, migraine subtype, autoinjector type, and dosing frequency. That structure gives multiple potential infringement pathways.

Claim dependency map (high level)

Independent 1: SC autoinjector + composition (NaCl/osmolality/volume/dose) + PK windows + acute migraine
- Dependent adds: pH, migraine subtype, specific autoinjector details, dosing frequency
Independent 8: SC injection + same composition + PK windows + acute migraine
- Dependent adds: pH, migraine subtype, autoinjector injection variant, dosing frequency

What related patents typically surround SC sumatriptan autoinjector formulations, and how does this one fit?

Direct answer: For SC sumatriptan products, nearby IP usually splits into:

formulation/tonicity and pH control,
device and delivery system claims (prefilled autoinjector specifics),
dosing regimens and method-of-use,
PK/bridging claims and exposure targets.

US 11,364,224 appears most directly aligned with formulation + PK and, secondarily, with delivery by autoinjector.

Landscape framing

Existing sumatriptan SC products in the US have historically been associated with known formulation and delivery designs. This patent’s unique strength is the explicit combination of:
- tight numeric formulation constraints (NaCl mass, osmolality band)
- numeric PK exposure windows
- method-of-use for acute migraine
- autoinjector device integration in claim 1 and 6

Where are generic and biosimilar risks in this patent space? Is this about Paragraph IV?

Direct answer: This is a small-molecule drug (sumatriptan succinate), so “biosimilar” risk is not applicable. For US market entry, the primary generic pathway is typically ANDA with potential Paragraph IV challenges to Orange Book-listed patents that cover formulation, method, or device aspects.

However, infringement risk hinges on whether US 11,364,224 is listed in the FDA Orange Book for the relevant reference product(s), and whether it expires soon relative to ANDA filing or settlement dates.

Because no Orange Book listing data or FDA reference product identification is provided here, the landscape cannot be tied to specific ANDA filers, Paragraph IV events, or settlement agreements.

How does US 11,364,224 compare to other SC sumatriptan patents in claim emphasis?

Direct answer: Many sumatriptan patents emphasize composition and device. This one adds an unusually explicit PK exposure band limitation. That changes both prosecution and enforcement: it is harder to argue “equivalence of a formulation” without addressing absorption and systemic exposure.

Comparative focus

Formulation-only patents are vulnerable if accused products match active and route but not exact tonicity.
PK-including patents increase evidentiary burden and can be used to test whether different tonicity/excipients still create the same absorption profile.

What evidence will matter most in enforcement for US 11,364,224?

Direct answer: The decisive evidence is likely to be:

composition testing: measured osmolality and pH of the accused formulation; NaCl concentration verification.
PK study results: Cmax, AUC0-2, AUC0-inf values after SC administration by the accused device/formulation.
device configuration: whether administration is “by autoinjector” and whether it matches the claim 6/14 structural details (0.5 mL prefills, disposable single-dose).

Key Takeaways

US 11,364,224 is a method-of-use patent with performance-based formulation and exposure limits, not a broad “SC sumatriptan for migraine” claim.
Independent claim 1 requires SC autoinjector delivery; independent claim 8 covers SC injection without requiring an autoinjector.
The claims are anchored to a specific composition: 4.2 mg sumatriptan succinate in 0.5 mL, NaCl 4.15–4.2 mg, and osmolality 275–315 mOsm/kg.
The claims include PK windows: Cmax 35–57 ng/mL, AUC0-2 30–50 ng·hr/mL, AUC0-inf 43–70 ng·hr/mL, with infringement possible if at least one parameter is within range.
Dependent claims narrow to pH 4.2–5.3, migraine subtype (with/without aura), autoinjector structure (0.5 mL prefilled disposable single dose), and a max 4x/day frequency.

FAQs

What happens if an accused product meets osmolality and pH but misses Cmax and AUC ranges?

If Cmax/AUC0-2/AUC0-inf are all outside the claimed “about” ranges such that none of the “at least one” PK limitations are met, the core independent-claim limitation is not satisfied.

Can a different tonicity agent avoid infringement under US 11,364,224?

Potentially, because the claims require an osmolality window and, indirectly, absorption consistent with the PK ranges. A different tonicity strategy that moves osmolality outside 275–315 mOsm/kg can avoid independent claim limitations.

Does the patent protect both autoinjector and syringe-based SC administration?

Yes. Claim 1 covers autoinjector administration. Claim 8 covers SC injection without requiring an autoinjector, and dependent claim 13 adds autoinjector administration to the claim 8 framework.

Is pH 4.2–5.3 an independent requirement?

No. Osmolality is in independent claims 1 and 8. pH is required only in dependent claims 2 and 9.

How does the “at least one of” PK formulation work in practice?

It lowers the bar for performance matching. An accused product may infringe if any one of Cmax, AUC0-2, or AUC0-inf falls within the corresponding claimed interval after administration under relevant conditions.

References (APA)

United States Patent and Trademark Office. “US Patent 11,364,224.” (Referenced for claim scope as provided in the prompt).

Title:	Pharmaceutical composition for treating migraine
Abstract:	The present application relates to a method of treating migraine or cluster headache in a human patient, said method comprising administering subcutaneously composition comprising sumatriptan or its pharmaceutically acceptable salt, in an amount equivalent to 3 mg sumatriptan base.
Inventor(s):	Prabhu Prabhakara, Rajesh Ramesh Patil, Piyush Gupta, Rajeev Singh Raghuvanshi, Anil N. Namboodiripad
Assignee:	Tonix Medicines Inc
Application Number:	US16/718,414
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:	United States Patent 11,364,224 (Sumatriptan SC Autoinjector) Scope, Claim Breakdown, and Patent Landscape Executive summary: US 11,364,224 claims a subcutaneous (SC) sumatriptan succinate acute migraine treatment delivered in a 0.5 mL autoinjector or injection, with tightly defined formulation parameters (sodium chloride amount, osmolality 275 to 315 mOsm/kg, pH 4.2 to 5.3) and tightly defined pharmacokinetic exposure windows (ranges for Cmax, AUC0-2, AUC0-inf). The claims are written to capture both autoinjector delivery and direct SC injection, and they limit dosing to a 4-times-a-day maximum. The enforceable scope is therefore largely driven by whether an accused product matches the specific composition and PK exposure characteristics, not merely “SC sumatriptan.” What does US 11,364,224 claim for acute migraine with sumatriptan succinate delivered subcutaneously? Direct answer (claim essence): US 11,364,224 is directed to a method of treating acute migraine in a patient by SC administration of a defined aqueous formulation of sumatriptan succinate (4.2 mg in 0.5 mL) with sodium chloride within a specified mass range, with osmolality 275 to 315 mOsm/kg and pH 4.2 to 5.3, and producing specified system exposure plasma PK ranges after administration. Independent claim 1 requires autoinjector delivery; independent claim 8 covers SC injection and includes the same formulation and PK windows. Claim 1 (autoinjector) scope Claim 1 requires all of the following elements: Medical indication: treating acute migraine. Route and device: subcutaneous administration by autoinjector. Dosage form/composition: aqueous solution 4.2 mg sumatriptan succinate per dose sodium chloride amount in 4.15 mg to 4.2 mg per 0.5 mL total volume total volume 0.5 mL Formulation physical chemistry: osmolality 275 to 315 mOsm/kg PK exposure characteristics: administration results in at least one of: Cmax ~ 35 to 57 ng/mL AUC0-2 ~ 30 to 50 ng·hr/mL AUC0-inf ~ 43 to 70 ng·hr/mL Dependent claims then narrow to pH, migraine subtypes, specific autoinjector size/type, and dosing frequency. Claim 8 (injection) scope Claim 8 parallels claim 1 but replaces autoinjector with subcutaneously injecting the composition and keeps: acute migraine treatment 4.2 mg sumatriptan succinate / 0.5 mL sodium chloride 4.15 to 4.2 mg osmolality 275 to 315 mOsm/kg at least one PK window (same Cmax/AUC ranges) dependent claims add pH, migraine with aura/without aura, and then bring back autoinjector in claim 13. How do the formulation limitations (NaCl, osmolality, pH) define infringement risk under US 11,364,224? Direct answer: The claims use numerical formulation parameters as structural constraints. An accused product that uses SC sumatriptan succinate but differs in osmolality or pH outside the claimed ranges (275–315 mOsm/kg and pH ~4.2–5.3) is harder to capture unless the relevant dependent claim is asserted or doctrine of equivalents is pursued. Independence already requires osmolality. P≤5.3 only appears in dependent claims. Key formulation numbers Sumatriptan succinate amount: 4.2 mg Total volume: 0.5 mL Sodium chloride range: 4.15 mg to 4.2 mg Osmolality: 275 to 315 mOsm/kg (required in claims 1 and 8) pH: ~4.2 to 5.3 (required in claims 2 and 9) Why osmolality and pH matter Osmolality is included as an explicit independent-claim limitation. That means claim 1/8 are not satisfied by “SC sumatriptan succinate” generally; they require a composition that yields an osmolality within a relatively broad but still bounded band. pH is not in independent claims, but it becomes required in dependent claims. Enforcement strategy typically targets the narrowest applicable claims if the accused formulation matches. The NaCl range is unusually tight for a “salt” excipient limitation. Even if an accused product uses different tonicity agents, different NaCl concentration, or substitutes excipients affecting osmolality, the accused composition may fail the independent limitations. How do the pharmacokinetic exposure windows (Cmax and AUC) control claim scope and design-around? Direct answer: Claims 1 and 8 require that the administered composition results in at least one of three PK exposure ranges. This turns the claims into performance-based limitations: infringement depends on measured exposure in the patient population/individuals for the claimed administration. PK parameters in the claims At least one of the following must fall within the claimed ranges: Cmax: about 35 to 57 ng/mL AUC0-2: about 30 to 50 ng·hr/mL AUC0-inf: about 43 to 70 ng·hr/mL Practical consequences The “at least one” structure reduces the need to match all three windows. If an accused product misses Cmax but lands AUC0-2 or AUC0-inf inside range, it could still meet the limitation. Conversely, a design-around can aim to push all of Cmax, AUC0-2, and AUC0-inf outside the windows, which may be achieved via changes that alter absorption kinetics (formulation tonicity, viscosity, injection parameters, autoinjector needle characteristics). Litigation often becomes a PK evidence dispute: which study conditions, which subjects, and how “about” is treated for the claimed ranges. What device limitations are included: does the patent require an autoinjector in the independent claim? Direct answer: Yes for claim 1, no for claim 8. Claim 1 requires SC by autoinjector. Claim 8 covers SC injection without requiring an autoinjector. Dependent claim 13 then ties injection to autoinjector use. Autoinjector limitations Claim 1: subcutaneous administration by autoinjector Claim 6: autoinjector comprises a 0.5 mL prefilled, ready-to-use, single dose, disposable auto-injector Claim 13: claim 8 method includes injecting using an autoinjector Claim 14: same 0.5 mL prefilled disposable single-dose autoinjector limitation Infringement mapping A product delivered by manual syringe SC injection could potentially fall under claim 8 (if composition and PK match). A product delivered by autoinjector would still fall under claim 1 if all conditions are met, and under claim 13/14 if asserting dependent claims against an injected product. How do the claims treat migraine subtype and dosing frequency? Direct answer: Aura vs no aura are handled through dependent claims tied to claim 3/10. Maximum dosing frequency is included as a dependent limitation. Migraine subtype dependencies Claim 3 depends on claim 1: acute migraine with aura Claim 5 depends on claim 3: acute migraine without aura Claim 10 depends on claim 8: acute migraine Claims 11 and 12: claim 11: acute migraine with aura claim 12: acute migraine without aura Frequency limitation Claim 7: maximum recommended frequency not more than four times a day Claim 15 repeats the same limit for claim 8-based methods This is a narrow behavioral limitation. If a product label or clinician instructions align with typical sumatriptan use (commonly limited dosing intervals), it may be difficult for an accused method to escape if other claim elements are met. What is the enforceable claim scope: what does US 11,364,224 cover and what is likely outside it? Direct answer: The patent is positioned at the intersection of (1) SC sumatriptan succinate in a 0.5 mL dose, (2) specific excipient/tonicity/osmolality characteristics, (3) a PK absorption profile window, and (4) device delivery (autoinjector in claim 1; not required in claim 8). Likely within scope SC sumatriptan succinate delivered as 0.5 mL with 4.2 mg dose and osmolality 275–315 mOsm/kg Formulations matching NaCl mass and producing at least one of the claimed PK ranges Autoinjector products matching the defined formulation and PK characteristics Likely outside (by claim construction) Products with correct active and dose but osmolality outside 275–315 mOsm/kg Products with correct route but without the defined PK exposure window (all three parameters outside the claimed ranges) Formulations with correct osmolality but pH outside 4.2–5.3 would not meet the dependent pH claims (but could still meet independent claims 1/8) Key litigation pivot The enforcement narrative likely centers on whether the accused composition yields the claimed osmolality and PK exposure under relevant administration conditions. How many independent and dependent claim “attack surfaces” exist in US 11,364,224? Direct answer: The patent includes two independent method claims (1 and 8) with multiple dependent claim layers that add narrower requirements on pH, migraine subtype, autoinjector type, and dosing frequency. That structure gives multiple potential infringement pathways. Claim dependency map (high level) Independent 1: SC autoinjector + composition (NaCl/osmolality/volume/dose) + PK windows + acute migraine Dependent adds: pH, migraine subtype, specific autoinjector details, dosing frequency Independent 8: SC injection + same composition + PK windows + acute migraine Dependent adds: pH, migraine subtype, autoinjector injection variant, dosing frequency What related patents typically surround SC sumatriptan autoinjector formulations, and how does this one fit? Direct answer: For SC sumatriptan products, nearby IP usually splits into: formulation/tonicity and pH control, device and delivery system claims (prefilled autoinjector specifics), dosing regimens and method-of-use, PK/bridging claims and exposure targets. US 11,364,224 appears most directly aligned with formulation + PK and, secondarily, with delivery by autoinjector. Landscape framing Existing sumatriptan SC products in the US have historically been associated with known formulation and delivery designs. This patent’s unique strength is the explicit combination of: tight numeric formulation constraints (NaCl mass, osmolality band) numeric PK exposure windows method-of-use for acute migraine autoinjector device integration in claim 1 and 6 Where are generic and biosimilar risks in this patent space? Is this about Paragraph IV? Direct answer: This is a small-molecule drug (sumatriptan succinate), so “biosimilar” risk is not applicable. For US market entry, the primary generic pathway is typically ANDA with potential Paragraph IV challenges to Orange Book-listed patents that cover formulation, method, or device aspects. However, infringement risk hinges on whether US 11,364,224 is listed in the FDA Orange Book for the relevant reference product(s), and whether it expires soon relative to ANDA filing or settlement dates. Because no Orange Book listing data or FDA reference product identification is provided here, the landscape cannot be tied to specific ANDA filers, Paragraph IV events, or settlement agreements. How does US 11,364,224 compare to other SC sumatriptan patents in claim emphasis? Direct answer: Many sumatriptan patents emphasize composition and device. This one adds an unusually explicit PK exposure band limitation. That changes both prosecution and enforcement: it is harder to argue “equivalence of a formulation” without addressing absorption and systemic exposure. Comparative focus Formulation-only patents are vulnerable if accused products match active and route but not exact tonicity. PK-including patents increase evidentiary burden and can be used to test whether different tonicity/excipients still create the same absorption profile. What evidence will matter most in enforcement for US 11,364,224? Direct answer: The decisive evidence is likely to be: composition testing: measured osmolality and pH of the accused formulation; NaCl concentration verification. PK study results: Cmax, AUC0-2, AUC0-inf values after SC administration by the accused device/formulation. device configuration: whether administration is “by autoinjector” and whether it matches the claim 6/14 structural details (0.5 mL prefills, disposable single-dose). Key Takeaways US 11,364,224 is a method-of-use patent with performance-based formulation and exposure limits, not a broad “SC sumatriptan for migraine” claim. Independent claim 1 requires SC autoinjector delivery; independent claim 8 covers SC injection without requiring an autoinjector. The claims are anchored to a specific composition: 4.2 mg sumatriptan succinate in 0.5 mL, NaCl 4.15–4.2 mg, and osmolality 275–315 mOsm/kg. The claims include PK windows: Cmax 35–57 ng/mL, AUC0-2 30–50 ng·hr/mL, AUC0-inf 43–70 ng·hr/mL, with infringement possible if at least one parameter is within range. Dependent claims narrow to pH 4.2–5.3, migraine subtype (with/without aura), autoinjector structure (0.5 mL prefilled disposable single dose), and a max 4x/day frequency. FAQs What happens if an accused product meets osmolality and pH but misses Cmax and AUC ranges? If Cmax/AUC0-2/AUC0-inf are all outside the claimed “about” ranges such that none of the “at least one” PK limitations are met, the core independent-claim limitation is not satisfied. Can a different tonicity agent avoid infringement under US 11,364,224? Potentially, because the claims require an osmolality window and, indirectly, absorption consistent with the PK ranges. A different tonicity strategy that moves osmolality outside 275–315 mOsm/kg can avoid independent claim limitations. Does the patent protect both autoinjector and syringe-based SC administration? Yes. Claim 1 covers autoinjector administration. Claim 8 covers SC injection without requiring an autoinjector, and dependent claim 13 adds autoinjector administration to the claim 8 framework. Is pH 4.2–5.3 an independent requirement? No. Osmolality is in independent claims 1 and 8. pH is required only in dependent claims 2 and 9. How does the “at least one of” PK formulation work in practice? It lowers the bar for performance matching. An accused product may infringe if any one of Cmax, AUC0-2, or AUC0-inf falls within the corresponding claimed interval after administration under relevant conditions. References (APA) United States Patent and Trademark Office. “US Patent 11,364,224.” (Referenced for claim scope as provided in the prompt). More… ↓ ⤷ 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
Tonix Meds	ZEMBRACE SYMTOUCH	sumatriptan succinate	SOLUTION;SUBCUTANEOUS	208223-001	Jan 28, 2016		RX	Yes	No	11,364,224	⤷ Start Trial				TREATMENT OF MIGRAINE	⤷ 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
Brazil	112018002433	⤷ Start Trial
Canada	2994748	⤷ Start Trial
China	107921023	⤷ Start Trial
European Patent Office	3331524	⤷ Start Trial
Mexico	2018001528	⤷ Start Trial
World Intellectual Property Organization (WIPO)	2017023361	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Summary for Patent: 11,364,224