Details for Patent: 11,617,755

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Which drugs does patent 11,617,755 protect, and when does it expire?

Patent 11,617,755 protects SYMBRAVO and is included in one NDA.

This patent has two hundred and twenty-one patent family members in thirty-two countries.

Summary for Patent: 11,617,755

Title:	Pharmaceutical compositions comprising meloxicam
Abstract:	Disclosed herein are compositions comprising an NSAID such as meloxicam and/or rizatriptan in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the NSAID for the treatment of pain such as migraine, arthritis, and other conditions. Also disclosed herein are methods of treating pain, such as migraine, comprising administering meloxicam and rizatriptan to a human being suffering from pain, such as migraine. For migraine, these methods may be particularly useful when the meloxicam and rizatriptan are administered while the human being is suffering from an acute attack of migraine pain or migraine aura. In some embodiments, the combination of meloxicam and rizatriptan may be administered in a manner that results in a Tmax of meloxicam of 3 hours or less.
Inventor(s):	Herriot Tabuteau
Assignee:	Axsome Therapeutics Inc
Application Number:	US17/677,906
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,617,755
Patent Claim Types: see list of patent claims	Use; Dosage form;

US Patent 11,617,755: Claim Scope, Exclusivity, Orange Book Status, and Generic Entry Risk for Meloxicam-Rizatriptan

US Patent No. 11,617,755 protects a method of treating migraine with a fixed combination of meloxicam, rizatriptan, sodium bicarbonate, and sulfobutylether-beta-cyclodextrin. The core commercial configuration is 20 mg meloxicam plus 10 mg rizatriptan administered orally in a dosage form designed for rapid meloxicam absorption.

The patent is directed to therapeutic use rather than a broad composition claim. Its main enforcement value is therefore against a product label, promotional program, or clinical use that instructs treatment of migraine with the claimed combination. The claims are narrower than a general patent covering any meloxicam-rizatriptan product because they require, among other elements, sodium bicarbonate, sulfobutylether-beta-cyclodextrin, a specified meloxicam dose, and treatment of a male patient.

What drug and product does US Patent 11,617,755 cover?

The patent covers the active-ingredient combination later commercialized as Axsome Therapeutics' Symbravo, an oral fixed-dose product containing meloxicam and rizatriptan. The FDA-approved product contains 20 mg of meloxicam and 10 mg of rizatriptan per tablet. Symbravo is indicated for the acute treatment of migraine with or without aura in adults.[2]

The patent claims identify four relevant formulation components:

Component	Role in claimed combination
Meloxicam	20 mg of meloxicam free acid, or molar equivalent salt
Rizatriptan	8-13 mg in dependent claim 2; 10 mg in claim 24
Sodium bicarbonate	Required by claim 1
Sulfobutylether-beta-cyclodextrin	Required by claim 1; a meloxicam complex is separately claimed

The patent does not claim meloxicam alone, rizatriptan alone, or every possible combination of the two drugs. It requires the four-component combination described in the claims.

What is the commercial product relationship?

The claimed combination corresponds closely to the commercial dose of Symbravo:

Attribute	Patent claim	Symbravo labeling
Meloxicam	About 20 mg	20 mg
Rizatriptan	About 8-13 mg, or 10 mg in claim 24	10 mg
Route	Oral in dependent claims	Oral
Indication	Acute migraine treatment	Acute migraine treatment
Sodium bicarbonate	Required by claim 1	Formulation excipient
Sulfobutylether-beta-cyclodextrin	Required by claim 1	Formulation excipient
Patient limitation	Male in claim 1	FDA indication is not limited to males

The commercial label is broader than the literal scope of claim 1 because the FDA indication covers adults generally, while claim 1 expressly requires a male patient.

How many independent claims does US 11,617,755 have?

Based on the claims supplied, the patent has one independent claim: claim 1. Claims 2 through 27 depend directly or indirectly from claim 1.

Claim 1 requires all of the following:

1. A method of treating migraine.
2. Administration to a human in need of treatment.
3. Administration of a combination containing meloxicam, rizatriptan, sodium bicarbonate, and sulfobutylether-beta-cyclodextrin.
4. Approximately 20 mg of meloxicam free acid, or an equivalent salt amount.
5. A male patient.
6. Migraine pain or aura.

The dependent claims add route, dose, pharmacokinetic, efficacy, rescue-medication, symptom, and formulation limitations.

What are the principal claim groups?

Claim group	Claims	Subject matter
Core treatment	1	Four-component combination, 20 mg meloxicam, male migraine patient
Oral administration and rizatriptan dose	2, 24	Oral administration; 8-13 mg or 10 mg rizatriptan
Early and sustained efficacy	3-5, 11-13, 19-21	Pain reduction, symptom freedom, sustained pain freedom, normal activity
Migraine symptoms	6, 7, 15, 26	Nausea, photophobia, phonophobia, pain, and aura
Rescue medication	8-10, 16-18, 27	Reduced or no rescue use; comparative 24-hour use reduction
Pharmacokinetics	14, 22, 23	Meloxicam Tmax of two hours or less, or one hour or less
Formulation chemistry	25	Complex of meloxicam and sulfobutylether-beta-cyclodextrin

What is the scope of claim 1?

Claim 1 is a narrow method-of-treatment claim with a potentially important commercial target. A potentially infringing product or use would need to involve the claimed four-component combination and the specified meloxicam amount, administered to a male migraine patient.

The male-patient limitation materially narrows literal infringement. A product label that instructs use in both men and women may still create infringement risk if it expressly or implicitly instructs use in male patients. Under induced-infringement principles, a manufacturer does not necessarily avoid liability merely because the label also covers noninfringing users. The analysis would depend on the label, marketing, prescribing instructions, and evidence of intended use.

Claim 1 also requires migraine pain or aura. A product marketed only for non-migraine headache would not satisfy the claimed disease limitation. A migraine label, however, would directly implicate that element.

Does the claim require a particular formulation?

Yes. The combination must contain sodium bicarbonate and sulfobutylether-beta-cyclodextrin. Those excipients are not optional under claim 1.

Claim 25 narrows the formulation further by requiring a complex between meloxicam and sulfobutylether-beta-cyclodextrin. This claim could be relevant to formulation designs using a defined cyclodextrin complex rather than merely including the excipient in a tablet blend.

The claims do not specify the amount of sodium bicarbonate or sulfobutylether-beta-cyclodextrin in the text supplied. That creates design space around excipient quantities, although a formulation omitting either component would fall outside claim 1.

What dose ranges are protected?

The patent protects multiple rizatriptan dose configurations.

Claim	Rizatriptan limitation
1	No express rizatriptan quantity
2	About 8 mg to about 13 mg
24	About 10 mg
26-27	Inherit the 10 mg limitation through claim 24

The 10 mg configuration is commercially significant because it corresponds to the labeled Symbravo strength. Claim 24 provides a direct dose-specific method claim for that product.

The meloxicam limitation is approximately 20 mg throughout the core claim structure. A product using a materially different meloxicam dose could avoid the literal dose limitation, although the meaning of "about" would depend on claim construction and the relevant specification disclosure.

What clinical outcomes are protected?

Claims 3 through 13 and 19 through 21 add treatment outcomes. These claims are not limited to the chemical composition; they require the patient to experience a specified clinical result.

Protected outcomes include:

• Reduction in migraine pain at 30 minutes.
• Reduction in pain by 24 hours.
• Freedom from the most bothersome migraine-associated symptom at two hours.
• Freedom from nausea, photophobia, or phonophobia.
• Reduced use of rescue medication.
• No rescue medication use.
• A 30%-50% lower likelihood of rescue medication use versus placebo during the first 24 hours.
• Sustained pain freedom by two hours.
• Pain freedom continuing for at least 24 hours.
• Ability to perform normal activities at 24 hours.

These limitations can strengthen the patent against a product that reproduces the formulation but is labeled for a different clinical use. They can also complicate enforcement because infringement may require proof that the claimed result occurred in the treated patient.

The efficacy claims may be less useful against an ANDA applicant whose proposed label copies the FDA-approved indication but does not expressly promise every claimed outcome. The risk turns on whether the FDA label, prescribing information, clinical-study references, or promotional materials instruct the claimed use.

What pharmacokinetic properties are protected?

Claims 14, 22, and 23 require a dosage form producing rapid meloxicam absorption under fasted conditions:

Claim	Pharmacokinetic requirement
14 and 22	Meloxicam Tmax of two hours or less
23	Meloxicam Tmax of one hour or less

These are product-performance limitations incorporated into method claims. They may require comparative pharmacokinetic evidence from a healthy human study under fasted conditions.

The one-hour limitation in claim 23 is narrower than the two-hour limitation. A competing product could attempt to avoid the claim by producing a slower meloxicam Tmax, although that strategy may conflict with the commercial objective of rapid migraine relief.

When does US Patent 11,617,755 lose exclusivity?

US Patent 11,617,755 is a utility patent issued on April 4, 2023.[1] The ordinary patent term is generally 20 years from the earliest effective nonprovisional U.S. filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and any applicable regulatory extensions.[3]

The grant date alone does not establish the expiration date. The controlling date is the patent-family priority and filing record, together with the USPTO term calculation. The patent should therefore be evaluated with its current USPTO Patent Center record and any FDA Orange Book listing rather than by adding 20 years to the issue date.

A patent term adjustment could extend the nominal expiration date. A terminal disclaimer could shorten it. There is no biosimilar-style automatic interchangeability framework for this small-molecule product.

What is the Orange Book status of the patent?

Symbravo is an FDA-approved small-molecule drug, so any relevant patent listing is evaluated under the Orange Book and Hatch-Waxman framework. The Orange Book identifies patents submitted by an NDA holder as covering the drug substance, drug product, or approved method of use.[4]

The commercial significance of US 11,617,755 depends on whether it is listed against the Symbravo NDA and which use codes are assigned. A method-of-use listing can support a Paragraph IV challenge and a 30-month stay if the NDA holder timely sues an ANDA applicant.[5]

A complete Orange Book analysis should distinguish:

• Drug-substance patents.
• Drug-product or formulation patents.
• Method-of-use patents.
• The NDA number.
• Patent-use codes.
• Listed expiration dates.
• Any delisting, correction, or patent-term adjustment.

The supplied claims clearly describe a method-of-use patent. They also contain formulation and pharmacokinetic limitations, but that does not automatically make the patent a drug-product listing. Listing classification depends on the NDA holder's submission and FDA's Orange Book treatment.

What Paragraph IV challenges and generic entry risks exist?

An ANDA applicant seeking approval for a generic meloxicam-rizatriptan product could challenge listed patents through a Paragraph IV certification. The most plausible validity and noninfringement theories would target the following issues:

Design-around opportunities

A generic applicant could consider:

• Omitting sodium bicarbonate.
• Omitting sulfobutylether-beta-cyclodextrin.
• Using a different solubilization technology.
• Using a meloxicam dose outside the claimed approximate range.
• Using a rizatriptan dose outside 8-13 mg.
• Developing a label that omits male-specific or claimed outcome instructions.
• Producing a formulation that does not meet the claimed Tmax limitation.

Each option could create regulatory or commercial disadvantages. A design that omits the cyclodextrin may have different dissolution, stability, or exposure characteristics. A label that omits the patented migraine use may be difficult to reconcile with the reference product's approved indication.

Validity pressure points

Potential validity issues include:

• Written-description support for the male-patient limitation.
• Enablement of all claimed clinical outcomes and pharmacokinetic thresholds.
• Definiteness of "about," "reduced use," "sustained pain freedom," and "ability to perform normal activities."
• Written-description support for the claimed 30%-50% rescue-medication reduction.
• Obviousness based on known meloxicam, rizatriptan, bicarbonate, and cyclodextrin technologies.
• Whether the clinical-result limitations distinguish the claimed method from prior migraine-treatment protocols.

The patent's most defensible commercial claims may be claims 1, 2, 24, and 25 because they focus on identifiable formulation and dose elements. The outcome claims can provide fallback positions but may be harder to enforce without patient-level clinical evidence.

Which companies are challenging the patent?

No Paragraph IV challenger, ANDA litigation matter, or settlement agreement can be identified from the claim text alone. A definitive challenger analysis requires current FDA Orange Book data, FDA Paragraph IV notifications, and federal court docket records.

No biosimilar challenge is relevant. Meloxicam and rizatriptan are chemically synthesized small molecules, and a competing product would proceed through the ANDA pathway rather than the biosimilar pathway under the Public Health Service Act.

What patent litigation affects Symbravo and AXS-07?

The supplied material does not identify litigation involving US 11,617,755. Litigation exposure should be assessed across:

1. Patent-infringement complaints filed by the NDA holder.
2. ANDA Paragraph IV notices.
3. Declaratory-judgment actions.
4. Patent settlements involving launch dates or licenses.
5. Inter partes review petitions.
6. Federal Circuit appeals.
7. Orange Book listing disputes.

The absence of a cited litigation record should not be treated as a finding that no case exists. Patent litigation status is dynamic and must be tied to a search date and docket number.

How strong is the patent estate compared with the underlying drug patents?

The original active ingredients provide little current exclusivity value. Rizatriptan and meloxicam were approved years before the combination product, and their basic compound patents are not the principal barrier to generic entry. The commercial estate instead depends on later patents covering:

• The fixed combination.
• Rapid meloxicam delivery.
• Cyclodextrin-based solubilization.
• Clinical treatment outcomes.
• Approved method of use.
• Additional formulation or manufacturing features.

Estate layer	Commercial strength
Original rizatriptan compound protection	Low for current U.S. exclusivity
Original meloxicam compound protection	Low for current U.S. exclusivity
Combination formulation	High if the generic must use the same excipient architecture
Method-of-use claims	Moderate to high, depending on Orange Book listing and label scope
Tmax claims	Moderate; requires pharmacokinetic proof
Clinical-outcome claims	Variable; proof-intensive
Manufacturing and formulation know-how	Potentially important but separate from this patent

The estate is strongest when the reference product's commercial formulation, approved label, and Orange Book listings converge. It is weaker if a generic can use a different formulation and secure approval with a carve-out label.

What revenue exposure does the patent create?

The patent is strategically important because it may cover the core commercial product rather than a peripheral indication. A successful generic launch could affect:

• Net sales of Symbravo.
• Prescriber retention.
• Managed-care formulary positioning.
• Pricing and rebates.
• Royalty or licensing economics.
• The value of Axsome's migraine franchise.

The actual revenue exposure depends on the number of listed patents, expected expiry dates, Paragraph IV outcomes, settlement terms, and the availability of a noninfringing formulation. Patent 11,617,755 alone does not establish the full period of market exclusivity.

Key Takeaways

• US 11,617,755 is a method-of-treatment patent for a meloxicam-rizatriptan migraine combination containing sodium bicarbonate and sulfobutylether-beta-cyclodextrin.
• The core meloxicam dose is approximately 20 mg.
• Dependent claims focus on 8-13 mg or 10 mg rizatriptan, oral delivery, rapid Tmax, sustained pain freedom, rescue-medication reduction, and migraine-associated symptoms.
• Claim 1 is unusually narrow because it requires treatment of a male patient.
• Claims 24 and 25 are commercially important for the 10 mg rizatriptan configuration and meloxicam-cyclodextrin complex.
• Generic risk will depend heavily on Orange Book listing, use codes, the reference-product label, and whether a noninfringing formulation can obtain ANDA approval.
• No biosimilar pathway applies.
• The patent term must be calculated from the family filing record, with patent-term adjustment and any terminal disclaimer considered.
• The original meloxicam and rizatriptan compound patents are less important than later combination and formulation patents.
• A complete market-exclusivity opinion requires the full Axsome patent family, Orange Book records, and current litigation dockets.

FAQs About US Patent 11,617,755

Does US 11,617,755 cover all meloxicam and rizatriptan combinations?

No. The claims require sodium bicarbonate and sulfobutylether-beta-cyclodextrin, along with the claimed meloxicam amount and migraine-treatment method.

Can a generic avoid the patent by using rizatriptan 5 mg?

Potentially, with respect to claims requiring 8-13 mg or 10 mg rizatriptan. The generic would still need to analyze claim 1 and any other patents covering the product.

Does the male-patient limitation eliminate infringement risk for a product labeled for all adults?

No. A broad adult label may still instruct treatment of male patients. Infringement would depend on the complete label, product composition, and induced-use evidence.

Is a meloxicam cyclodextrin complex required for every claim?

No. Claim 25 expressly requires the complex, but claim 1 requires only that the combination contain sulfobutylether-beta-cyclodextrin. The complex limitation is not present in every claim.

Can the patent block an over-the-counter migraine product?

The patent claims a specific prescription-style combination and treatment method. An over-the-counter product could create infringement risk if it practiced every claim element, but regulatory status alone would not determine infringement.

References

1. United States Patent and Trademark Office. (2023). U.S. Patent No. 11,617,755, Methods of treating migraine.
2. U.S. Food and Drug Administration. (2025). Symbravo prescribing information.
3. United States Code. 35 U.S.C. §§ 154, 156.
4. U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book.
5. United States Code. 21 U.S.C. § 355(j); 35 U.S.C. § 271(e).

Drugs Protected by US Patent 11,617,755

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes	11,617,755					ACUTE TREATMENT OF MIGRAINE

International Family Members for US Patent 11,617,755

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016218992
Australia	2018205790
Australia	2018265411
Australia	2019203328
Australia	2019297360
Australia	2020205306