United States Patent 11,458,145: Meloxicam Injection Claims, Scope, Expiration and Patent Landscape

U.S. Patent No. 11,458,145 protects a narrow intravenous meloxicam treatment regimen for moderate-to-severe adult pain. The independent claim requires a 30 mg intravenous dose delivered as approximately 1 mL of a 30 mg/mL meloxicam nanocrystal aqueous dispersion, followed by an approximately 24-hour repeat dose. The formulation must contain meloxicam nanocrystals, povidone, sodium deoxycholate, an excipient and water. The patent does not broadly cover all meloxicam injections or all uses of meloxicam.

The strongest infringement risk applies to an adult-pain product that reproduces the claimed dose, concentration, nanocrystal format, excipient system and once-daily repeat regimen. A product that uses a different concentration, delivery schedule, formulation architecture or patient population may avoid literal infringement, subject to the doctrine of equivalents and the remaining patent estate.

What does U.S. Patent 11,458,145 protect?

The patent protects a method of treating moderate-to-severe pain with a specific intravenous meloxicam regimen. Claim 1 requires all of the following:

Required element	Claim limitation
Patient	Adult human patient in need of treatment
Condition	Moderate-to-severe pain
Active ingredient	Meloxicam
Dosage form	Aqueous dispersion containing meloxicam nanocrystals
Concentration	30 mg/mL
Initial dose	Approximately 1 mL, equivalent to approximately 30 mg meloxicam
Route	Intravenous bolus administration
Frequency	Once daily
Repeat dose	Approximately every 24 hours after the first dose
Formulation components	Meloxicam nanocrystals, povidone, sodium deoxycholate, an excipient and water
Clinical result	Reduced summed pain intensity difference and reduced rescue analgesic use at 48 hours

The claim is a method claim rather than a broad composition claim. It does not, on its face, claim every composition containing meloxicam, every intravenous meloxicam product, or every nanocrystal formulation.

The claim also uses the transitional phrase "consists of" for the bolus formulation. That language is narrower than "comprises." In a literal infringement analysis, an accused formulation containing an additional unlisted component could present a non-infringement argument, depending on how the court construes the claim and whether the additional component is considered inherent, immaterial or compatible with the claimed formulation.

How narrow is the independent claim?

The independent claim is narrow in formulation, dosing and use. It combines several limitations that must be satisfied in the same treatment method.

A competitor would generally need to address five principal design-around categories:

Use a different meloxicam concentration.
Administer a different volume or dose.
Use a non-nanocrystal meloxicam formulation.
Replace or omit povidone or sodium deoxycholate.
Use a different dosing interval or administration method.

The claim's "about" language creates numerical flexibility around 1 mL, 30 mg/mL and approximately 24 hours. It does not eliminate the requirement for a substantially similar 30 mg intravenous dose administered once daily. The scope of "about" would depend on intrinsic evidence, prosecution history, formulation tolerances and the ordinary meaning of the terms in the pharmaceutical field.

The clinical-outcome limitation may also affect enforcement. Claim 1 requires a reduction in summed pain intensity difference and rescue analgesic use 48 hours after treatment. A patentee may argue that these are inherent results of practicing the claimed regimen. An accused party may argue that the limitation requires proof of the specified clinical outcome, particularly if the claim is construed as requiring an actual patient result rather than merely an intended use.

What do the dependent claims add?

The dependent claims extend the method into surgical-pain indications, specific clinical settings and specific formulation and outcome limitations.

Claim	Added subject matter	Commercial significance
2	Post-surgical pain	Targets the principal hospital and perioperative use case
3	Administration after surgery	Narrows timing relative to the surgical procedure
4	Open surgery	Covers postoperative pain after open procedures
5	Laparoscopic surgery	Covers minimally invasive surgical procedures
6	Surgery on hard tissue	May cover orthopedic, dental or other hard-tissue procedures
7	Surgery on soft tissue	May cover abdominal, gynecologic, plastic or other soft-tissue procedures
8	Summed pain intensity difference through 24 hours of approximately -4262.1	Adds a quantitative efficacy limitation
9	Summed pain intensity difference through 48 hours of -10,600.0 ± 442.31	Adds a narrower clinical-performance limitation
10	Specifies a list of possible excipients	Defines the formulation excipient universe
11	Requires sucrose as the excipient	Creates a narrower formulation claim
12	Treatment without an opioid	Supports opioid-sparing or opioid-free use
13	Repeat dosing for 48 hours	Narrows the duration of the daily regimen

Claims 2 through 7 are particularly relevant to hospital products marketed for acute postoperative pain. Claim 12 may be commercially important in formularies and opioid-sparing protocols, but its enforcement may be difficult if opioids are permitted as rescue medication elsewhere in the treatment protocol. The claim language should be analyzed against the specification and prosecution history to determine whether "without administration of an opioid" excludes any opioid use during the treatment period or only requires that the meloxicam regimen itself be administered without an opioid.

What formulation is protected by Patent 11,458,145?

The formulation limitation requires an aqueous dispersion containing:

30 mg meloxicam nanocrystals per approximately 1 mL dose;
povidone;
sodium deoxycholate;
one qualifying excipient; and
water.

Claim 10 lists a broad group of possible excipients, including sucrose, methyl cellulose, hydroxypropyl methyl cellulose, sodium alginate, starch derivatives, gums and cellulose derivatives. Claim 11 narrows the formulation to sucrose.

The use of nanocrystals is material. A conventional dissolved meloxicam solution, coarse suspension, liposomal formulation, emulsion or alternative particulate system may not satisfy the nanocrystal limitation. The exact particle-size definition, surface characteristics, crystalline form and manufacturing process should be taken from the patent specification and file history rather than inferred solely from the claims.

The formulation claims do not appear in the supplied claim set as standalone composition claims. The formulation is claimed as part of a method of treatment. That distinction matters for enforcement against a manufacturer. A manufacturer may not directly practice the claimed method, while a label, prescribing information, distribution strategy or instructions for use may support induced-infringement allegations under 35 U.S.C. § 271(b).

How do the clinical limitations affect claim scope?

Claims 8 and 9 specify summed pain intensity difference, or SPID, values. These limitations link the patent to clinical-trial performance rather than only to dose and formulation.

Claim 8 requires an SPID through 24 hours of approximately -4262.1. Claim 9 requires an SPID through 48 hours of -10,600.0 with a stated variation of ±442.31. These limitations may create additional validity and enforcement issues:

The patent must provide adequate written-description support for the numerical values.
The statistical meaning of the stated variation must be clear.
The claim must identify the measurement scale, patient population and calculation methodology sufficiently to permit reproducibility.
Infringement may require clinical or comparative evidence rather than merely testing the formulation.
A generic sponsor may challenge the limitations as indefinite if the measurement framework is not sufficiently defined.

The efficacy limitations can also provide a defense opportunity. A product may use the same dose and formulation but generate a materially different clinical profile because of patient selection, surgery type, concomitant analgesia or study design. Whether that avoids infringement depends on claim construction and whether the clinical result is treated as an inherent property.

What is the likely patent term and expiration framework?

Patent No. 11,458,145 issued on October 4, 2022. Its enforceable term is determined by the earliest applicable nonprovisional or international filing date, adjusted for patent-term adjustment and any applicable patent-term extension. The issue date does not establish the expiration date.

Patent term issue	Effect
Earliest effective filing date	Establishes the basic 20-year term under 35 U.S.C. § 154
Patent-term adjustment	Can extend the term for USPTO examination delays
Patent-term extension	May extend an approved drug patent under 35 U.S.C. § 156, subject to statutory limits
Terminal disclaimer	Can cut off the term if the patent is tied to an earlier patent
Continuation status	May produce different claim sets with overlapping but separate expiration dates
Orange Book listing	Provides the FDA-listed expiration information used for approved-product exclusivity analysis

The patent should therefore be evaluated with the USPTO patent-term information and the FDA Orange Book entry for the relevant meloxicam product. A continuation patent may expire on the same date as its parent even if it issued later.

What is the Orange Book status of Patent 11,458,145?

The commercial relevance of Patent 11,458,145 depends on whether it is listed in the Orange Book for an approved intravenous meloxicam product, including Anjeso, and whether the listing identifies a method-of-use indication, formulation or other patent category.

An Orange Book-listed method-of-use patent can affect an abbreviated new drug application, or ANDA, if the proposed generic label overlaps the patented indication. A generic applicant may:

certify that the patent has expired;
submit a Paragraph III certification with a delayed launch;
submit a Paragraph IV certification asserting that the patent is invalid, unenforceable or not infringed; or
carve out the patented method from its labeling where FDA regulations permit a legally effective skinny label.

A method patent is not automatically a barrier to every generic version of meloxicam. Its impact depends on the proposed label. If the generic seeks approval for the same 30 mg intravenous postoperative-pain regimen, the patent is more relevant than if the applicant seeks a different indication, dose or administration schedule.

The FDA-approved product label for Anjeso identifies intravenous meloxicam as a 30 mg/mL injection for the management of moderate-to-severe pain in adults, with a recommended 30 mg dose administered once daily and a maximum treatment duration of seven days.[2] That approved use is closely aligned with the core regimen claimed in Patent 11,458,145.

Which companies are challenging Patent 11,458,145?

No Paragraph IV challenger or patent litigation outcome can be established from the claim text alone. Public litigation and ANDA records must be matched to the patent number, the relevant NDA and any related patents in the same family.

For business planning, the relevant challenger categories are:

Challenger	Typical pathway	Risk to patent owner
Generic injectable manufacturer	ANDA with Paragraph IV certification	Direct validity and infringement litigation
Generic manufacturer with carved-out label	ANDA with Section viii statement	May launch for non-patented uses
505(b)(2) applicant	Modified formulation, dose or indication	May challenge listed patents while pursuing product changes
Hospital-compounding supplier	Compounded or alternative preparation	Potential infringement and regulatory exposure depending on activity
New drug developer	Reformulated IV, oral or long-acting meloxicam	May avoid this patent while encountering separate formulation patents

The most credible Paragraph IV attack would likely focus on obviousness of the combination of dose, nanocrystal formulation, stabilizers and once-daily postoperative use. Other possible attacks include written-description and enablement challenges to the clinical-outcome limitations, indefiniteness of the numerical SPID limitations, and non-infringement based on formulation composition or dosing interval.

How does this patent compare with composition and manufacturing patents?

Patent 11,458,145 is a use patent. It should be separated from three other patent categories that may affect market entry:

Formulation patents

These may claim the nanocrystal dispersion, stabilizer combination, particle characteristics, viscosity, pH, osmolality or injectable presentation independently of the treatment method. A competitor could avoid Patent 11,458,145 but still infringe a formulation patent.

Manufacturing patents

These may cover precipitation, milling, homogenization, drying, sterilization, aseptic processing or control of crystal size. Manufacturing patents can create a practical barrier even where the marketed product uses a different label.

Method-of-use patents

These may cover postoperative pain, opioid-sparing treatment, specific surgeries, dosing duration or pain-score outcomes. Patent 11,458,145 belongs principally to this category, although its method claim incorporates formulation limitations.

A complete freedom-to-operate review must therefore examine the entire patent family and related U.S. continuations, not only the issued claims in Patent 11,458,145.

What generic launch scenarios exist?

Scenario 1: Full-label Paragraph IV challenge

A generic applicant seeks the same 30 mg/mL intravenous indication and includes postoperative moderate-to-severe pain in its label. The applicant certifies Patent 11,458,145 under Paragraph IV. A timely patent-infringement action can trigger a 30-month stay of FDA approval under the Hatch-Waxman framework, subject to statutory exceptions.[3]

Scenario 2: Skinny-label launch

The applicant removes the patented postoperative or opioid-free use from its label while retaining non-overlapping indications. This may reduce method-of-use infringement risk but may create induced-infringement disputes if marketing, prescribing materials or product instructions encourage the patented regimen.

Scenario 3: Formulation design-around

The applicant uses a different stabilizer system, omits sodium deoxycholate, substitutes another surfactant or changes the nanocrystal technology. This approach targets the formulation limitations in claim 1 and claim 11.

Scenario 4: Regimen design-around

The applicant uses a different concentration, a different volume, a non-bolus infusion, a different dosing interval or a shorter treatment duration. The design must still satisfy FDA requirements for safety, efficacy and labeling.

Scenario 5: 505(b)(2) challenge

A sponsor develops a modified injectable meloxicam product and addresses the listed patents through certification or statement procedures applicable to the 505(b)(2) pathway. The regulatory route does not eliminate patent risk.

How strong is the patent estate around this product?

Patent 11,458,145 has meaningful commercial relevance because its core regimen tracks the approved 30 mg/mL intravenous meloxicam product. Its practical strength is reduced by the number of required limitations.

The estate is strongest where:

the competing product uses meloxicam nanocrystals;
the formulation contains povidone and sodium deoxycholate;
the dose is approximately 30 mg in approximately 1 mL;
administration is intravenous and once daily;
the labeled use is adult moderate-to-severe postoperative pain; and
the product is promoted for opioid-free or opioid-sparing treatment.

The estate is weaker against products that use a different formulation platform or seek a label outside the patented postoperative regimen. The claims are also vulnerable to technical disputes over "about," "nanocrystals," the "consists of" language and the clinical SPID limitations.

What patent litigation and settlement issues should be monitored?

The principal events to monitor are:

Paragraph IV notices involving the patent or related Anjeso patents.
District-court complaints filed within 45 days after a Paragraph IV notice.
Declaratory-judgment actions involving non-infringement or invalidity.
ANDA approval dates and any 30-month stay.
Settlement agreements establishing a licensed generic entry date.
Federal Circuit decisions affecting claim construction or obviousness.
Terminal disclaimers, reexaminations, post-grant proceedings and patent-term records.
Orange Book delistings or changes to the listed use code.

A settlement does not necessarily establish patent validity. It may reflect commercial considerations, litigation cost, supply arrangements, authorized-generic rights or an agreed launch date.

Key Takeaways

Patent 11,458,145 is a narrow method-of-treatment patent for intravenous meloxicam.
Claim 1 requires approximately 30 mg of meloxicam in approximately 1 mL of a 30 mg/mL nanocrystal aqueous dispersion.
The required formulation includes povidone, sodium deoxycholate, an excipient and water.
The regimen requires an initial intravenous bolus followed by a repeat bolus approximately every 24 hours.
The dependent claims target postoperative pain, open and laparoscopic surgery, hard- and soft-tissue procedures, opioid-free treatment and 48-hour dosing.
The patent does not broadly claim every meloxicam injection or every meloxicam formulation.
Orange Book and litigation significance depend on the patent's listing for the approved product and the scope of any generic label.
The principal generic strategies are Paragraph IV litigation, a skinny-label launch, formulation substitution and dosing-regimen design-around.
The related patent family, formulation patents and manufacturing patents may present separate barriers beyond Patent 11,458,145.

FAQs

Does Patent 11,458,145 cover oral meloxicam?

No. The supplied claims require intravenous administration of a 30 mg/mL meloxicam nanocrystal aqueous dispersion. Oral tablets, capsules and oral suspensions fall outside the literal scope of claim 1.

Does the patent cover a 15 mg intravenous meloxicam dose?

Not expressly. Claim 1 requires approximately 1 mL of a 30 mg/mL dispersion, corresponding to approximately 30 mg meloxicam. A 15 mg dose would present a substantial non-infringement argument, although the final analysis would depend on claim construction.

Can a generic launch before patent expiration with a carved-out label?

Potentially. A generic applicant may pursue a Section viii labeling strategy if the patented method can be removed without undermining the remaining approved uses. The feasibility depends on the FDA use code, the proposed label and the applicant's marketing conduct.

Is a biosimilar pathway relevant to intravenous meloxicam?

No. Meloxicam is a small-molecule active pharmaceutical ingredient. A competing product would generally use an ANDA, 505(b)(2) application or full new drug application rather than the biosimilar pathway under the Public Health Service Act.

Does using sucrose create a separate infringement risk?

Yes. Claim 11 specifically requires sucrose as the excipient. A product using sucrose together with the other claimed formulation elements and regimen would face a more direct claim-overlap analysis than a product using a different excipient.

References

United States Patent and Trademark Office. (2022). U.S. Patent No. 11,458,145, methods of treating pain using meloxicam.
U.S. Food and Drug Administration. (2020). Anjeso (meloxicam) injection prescribing information.
U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book.
35 U.S.C. §§ 154, 156, 271, 282.
21 U.S.C. § 355(j).

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Baudax	ANJESO	meloxicam	SOLUTION;INTRAVENOUS	210583-001	Feb 20, 2020		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				MANAGEMENT OF MODERATE-TO-SEVERE PAIN BY INJECTION	⤷ 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	2019231858	⤷ Start Trial
Australia	2019364416	⤷ Start Trial
Canada	3117209	⤷ Start Trial
China	111201020	⤷ Start Trial
China	111356453	⤷ Start Trial
European Patent Office	3761977	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,458,145

Which drugs does patent 11,458,145 protect, and when does it expire?

Summary for Patent: 11,458,145