Details for Patent: 9,808,468

Which drugs does patent 9,808,468 protect, and when does it expire?

Patent 9,808,468 protects VIVLODEX and is included in one NDA.

This patent has sixteen patent family members in sixteen countries.

Summary for Patent: 9,808,468

Title:	Formulation of meloxicam
Abstract:	Unit dosage forms of meloxicam containing either 5 mg or 10 mg of meloxicam that provide effective pain relief and have desirable pharmacokinetic properties are described. The unit dosage forms can provide pain relief when a single unit dose is administered to a patient and useful for treating pain such as osteoarthritis pain at a relatively low systemic exposure to meloxicam.
Inventor(s):	H. William Bosch
Assignee:	Iceutica Pty Ltd
Application Number:	US15/595,446
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,808,468
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

US Patent 9,808,468: Meloxicam Nanoparticle Claims, Exclusivity, and Patent Landscape

US Patent No. 9,808,468 protects specific 5 mg and 10 mg capsule formulations of meloxicam for osteoarthritis, not meloxicam generally. The patent combines particle-size limits, rapid dissolution, pharmacokinetic exposure, food-state conditions, and a method-of-treatment limitation. Its commercial relevance is tied to low-dose meloxicam products using fine-particle technology, particularly Vivlodex.

The strongest claim element is the required combination of:

• Meloxicam in capsule form;
• 100-1,000 nm median particle size by volume;
• D(0.9) greater than 1,200 nm and less than 4,000 nm;
• Rapid dissolution under specified USP conditions;
• Defined AUC, Cmax, and, in dependent claims, Tmax;
• Administration for treating osteoarthritis.

The patent does not cover every meloxicam capsule, every nanoparticulate meloxicam formulation, or conventional 7.5 mg and 15 mg meloxicam tablets.

What does US Patent 9,808,468 cover?

US 9,808,468 covers methods of treating osteoarthritis by administering defined capsule formulations of meloxicam. Independent claims 1, 9, and 17 cover three pharmacokinetic and dosing configurations:

Independent claim	Dose	Food state	AUC requirement	Cmax requirement	Dissolution requirement
Claim 1	5 mg	Fasted	7,500-20,000 h·ng/mL	350-950 ng/mL	At least 80% in 10 minutes
Claim 9	10 mg	Fasted	16,000-44,000 h·ng/mL	700-1,900 ng/mL	At least 80% in 15 minutes
Claim 17	10 mg	Fed	15,000-42,000 h·ng/mL	525-1,500 ng/mL	At least 80% in 15 minutes

Every independent claim also requires meloxicam particles with:

• Median volume-based particle size between 100 nm and 1,000 nm; and
• D(0.9) above 1,200 nm and below 4,000 nm.

The claim structure is cumulative. A potentially infringing product must satisfy the dose, dosage form, particle-size, dissolution, pharmacokinetic, and treatment limitations of at least one asserted claim.

How are the claims organized?

Independent claims 1, 9, and 17

Claim 1 covers a 5 mg fasted-state regimen. Claims 9 and 17 cover 10 mg regimens, with claim 9 directed to fasted administration and claim 17 directed to fed administration.

The claims are method claims rather than pure composition claims. That distinction affects enforcement. The patent owner would generally need to establish that the accused product is used, prescribed, labeled, or otherwise connected to treatment of osteoarthritis under the claimed conditions. A product sold for a different indication could still create risk if the relevant use is induced or if the product labeling instructs the claimed administration.

Dependent claims 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24

These claims narrow dissolution or pharmacokinetic limitations. The dissolution claims require at least 90% dissolution within specified times.

For the 5 mg formulation, claim 2 covers 90% dissolution in:

• Eight minutes or less;
• Seven minutes or less;
• Six minutes or less; or
• Five minutes or less.

For the 10 mg formulations, claims 10 and 18 cover 90% dissolution in five to 14 minutes, depending on the selected limitation.

Claims 5-8, 13-16, and 21-24 narrow AUC or Cmax to 80%-125% of stated reference values. For example:

• The 5 mg fasted-state AUC claims use 13,610 ng·h/mL as the reference;
• The 5 mg Cmax claims use 1,253 ng/mL;
• The 10 mg fasted-state AUC claims use 29,173 ng·h/mL;
• The 10 mg fed-state AUC claims use 27,146 ng·h/mL;
• The 10 mg fed-state Cmax claims use 974 ng/mL.

These dependent claims create narrower fallback positions but may also create evidentiary challenges because infringement may depend on clinical or comparative pharmacokinetic testing.

What technical features distinguish the patent?

Nanoparticle and particle-size limitations

The patent requires a median particle size between 100 nm and 1,000 nm on a volume basis. This is a relatively broad nanoscale range, but it is constrained by the D(0.9) limitation.

D(0.9) identifies the particle diameter below which 90% of the particle-volume distribution falls. The claimed range requires:

• D(0.9) greater than 1,200 nm; and
• D(0.9) less than 4,000 nm.

The combination indicates a formulation with a nanoscale median but a controlled coarse tail. A formulation could therefore fail the claim even if its median particle size is within range if its D(0.9) is 4,000 nm or higher. Conversely, a formulation with a very narrow nanoscale distribution could fail if its D(0.9) is 1,200 nm or lower.

Particle-size measurement is likely to be a central infringement and validity issue. Results can vary with:

• Laser-diffraction versus dynamic-light-scattering methods;
• Wet versus dry dispersion;
• Dispersing medium;
• Sonication energy;
• Agglomeration control;
• Number-based versus volume-based calculations.

The claim expressly requires a volume basis. A manufacturer could not rely on a number-based median alone to establish noninfringement.

Dissolution limitations

The dissolution tests are highly specific. They require:

• USP Apparatus 1;
• Basket rotation at 100 rpm;
• 37°C ±0.5°C;
• pH 6.1 phosphate buffer;
• 0.1% SLS;
• 500 mL medium for the 5 mg formulation;
• 1,000 mL medium for the 10 mg formulation.

The 5 mg and 10 mg formulations are not tested under identical conditions. A generic developer would need to reproduce the specified conditions precisely when assessing risk.

The dissolution limitation may be commercially important because conventional meloxicam has low aqueous solubility. Reducing particle size increases surface area and can accelerate dissolution. The claimed dissolution profile is therefore a functional marker for the fine-particle formulation rather than an incidental laboratory result.

What pharmacokinetic scope does US 9,808,468 add?

The patent does not rely solely on formulation structure. It also claims the exposure profile produced after administration to healthy adults.

Fasted-state claims

The 5 mg fasted-state claims require:

• Mean AUC of 7,500-20,000 h·ng/mL;
• Mean Cmax of 350-950 ng/mL;
• Median Tmax of one to three hours in dependent claims.

The 10 mg fasted-state claims require:

• Mean AUC of 16,000-44,000 h·ng/mL;
• Mean Cmax of 700-1,900 ng/mL;
• Median Tmax of one to three hours in dependent claims.

Fed-state claims

The 10 mg fed-state claims require:

• Mean AUC of 15,000-42,000 h·ng/mL;
• Mean Cmax of 525-1,500 ng/mL;
• Median Tmax of three to seven hours in dependent claims.

The fed-state claims recognize a delayed absorption profile relative to the fasted state. A product might meet the particle and dissolution limitations but fall outside the patent if its fed-state Cmax, AUC, or Tmax does not fall within the claimed ranges.

When does US Patent 9,808,468 lose exclusivity?

The patent issued on November 7, 2017. Its ordinary patent term is generally measured from the earliest effective nonprovisional filing date, subject to patent-term adjustment, terminal disclaimers, and any applicable regulatory extension.

Public patent records identify an effective priority chain beginning in 2013. On that basis, the base term would ordinarily extend into 2033 or later, depending on the specific nonprovisional filing date and patent-term adjustment. The exact expiration date should be confirmed from the USPTO patent-term data and any Orange Book listing.

Event	Date or status
Earliest publicly identified priority period	2013
Patent issued	November 7, 2017
Patent number	US 9,808,468
Patent type	Utility patent
Principal subject matter	Fine-particle meloxicam capsules and osteoarthritis treatment
Ordinary base-term window	Approximately 2033-2034, subject to PTA and terminal disclaimer review
Regulatory exclusivity	Separate from patent term and dependent on the approved NDA
Orange Book status	Must be assessed against the current FDA listing for the relevant meloxicam product

Patent expiration and FDA marketing exclusivity are separate. FDA exclusivity may expire before the patent, while a patent can remain enforceable after regulatory exclusivity ends.

What is the Orange Book status of US 9,808,468?

The commercial connection is to low-dose meloxicam capsule products, including Vivlodex, an FDA-approved 5 mg and 10 mg meloxicam capsule product. Vivlodex was approved under NDA 206814 for osteoarthritis-related pain management. The product uses SoluMatrix fine-particle technology associated with Iroko Pharmaceuticals and its successor commercial organizations.

The Orange Book analysis should distinguish:

1. Whether US 9,808,468 is currently listed for the relevant NDA;
2. Whether the listing covers the approved 5 mg and 10 mg capsule strengths;
3. Whether any patent use code limits the listed method;
4. Whether later patents have been listed for formulation, particle-size, manufacturing, or use features;
5. Whether the listed patent has been delisted, expired, or replaced.

A listed method patent can require an ANDA applicant to make a Paragraph IV certification if the applicant seeks approval before patent expiration. An applicant can also use a section viii statement to carve out a patented method, but that strategy depends on the scope of the FDA-approved labeling and the specific use code.

What Paragraph IV challenge risks exist?

A generic applicant seeking approval for a meloxicam capsule could challenge US 9,808,468 through a Paragraph IV certification. The principal invalidity and noninfringement theories would likely involve the following issues.

Anticipation

An anticipation challenge would require a single prior-art reference to disclose the claimed combination, including:

• Capsule dosage form;
• 5 mg or 10 mg meloxicam;
• Claimed particle-size distribution;
• Claimed dissolution result;
• Claimed pharmacokinetic ranges;
• Osteoarthritis treatment.

The combination of particle distribution, dissolution, and pharmacokinetics may make a complete anticipation reference difficult to identify. A prior reference disclosing micronized meloxicam may not disclose the claimed D(0.9) range or the specified dissolution test.

Obviousness

Obviousness would likely be the more substantial validity theory. A challenger could argue that:

• Nanomilling or fine-particle processing was known for poorly soluble drugs;
• Meloxicam particle-size reduction was known;
• Rapid dissolution was an expected result of increasing surface area;
• Dose proportionality made the 5 mg and 10 mg exposure ranges predictable;
• The pharmacokinetic limitations are inherent or routine optimization parameters.

The patent owner would likely respond that the claimed combination produces a distinct exposure profile, particularly rapid absorption and defined fed-state and fasted-state behavior, and that the D(0.9) limitation is not an arbitrary optimization.

Indefiniteness and written description

The particle-size terms may receive scrutiny regarding test methodology and reproducibility. The written description question would focus on whether the specification supports the full combination of:

• Median particle size of 100-1,000 nm;
• D(0.9) of 1,200-4,000 nm;
• Rapid dissolution;
• Multiple dose and food-state pharmacokinetic ranges.

The pharmacokinetic claims also raise questions about population definition, sampling, assay methodology, and statistical treatment. The claims refer to a population of healthy adults, which may limit direct comparison with patient populations but does not eliminate infringement risk if the claimed product produces the specified result in the defined testing population.

How strong is the patent estate for low-dose meloxicam?

US 9,808,468 is strongest when asserted against a product that reproduces the commercial formulation architecture:

• 5 mg or 10 mg capsule;
• Fine-particle meloxicam;
• Median particle size below 1,000 nm;
• D(0.9) in the 1,200-4,000 nm range;
• Rapid dissolution;
• Similar fasted or fed pharmacokinetic profile.

It is weaker against products that use:

• Conventional crystalline meloxicam;
• A larger particle-size distribution;
• A non-capsule dosage form;
• A different release mechanism;
• A formulation that produces materially different Cmax or AUC;
• A label that omits osteoarthritis treatment, where legally and commercially feasible.

The patent is also narrower than a composition claim covering any meloxicam nanoparticle formulation. The requirement to treat osteoarthritis and satisfy pharmacokinetic ranges creates potential noninfringement positions, but those positions may be difficult to exploit if the generic product is therapeutically substitutable and its label tracks the reference product.

What other patents may surround US 9,808,468?

The relevant patent estate is likely to include several layers.

Core fine-particle formulation patents

These cover the preparation and use of reduced-particle-size meloxicam. They may claim:

• Wet milling;
• Nanoparticle production;
• Stabilizers and surfactants;
• Particle-size distributions;
• Solid dosage forms;
• Enhanced dissolution.

Method-of-use patents

These may cover:

• Osteoarthritis treatment;
• Reduced-dose meloxicam administration;
• Treatment with 5 mg or 10 mg capsules;
• Improved tolerability or gastrointestinal safety;
• Food-state administration;
• Rapid onset of analgesic effect.

Manufacturing patents

Manufacturing rights may cover:

• Milling parameters;
• Stabilizer selection;
• Spray drying;
• Granulation;
• Drying and recovery;
• Encapsulation;
• Control of agglomeration.

These patents can create a practical barrier even when a competitor designs around the principal method claim. A product may avoid US 9,808,468 but still implicate a process or formulation patent.

Regulatory listing strategy

For an ANDA applicant, the relevant landscape is not limited to one patent number. The applicant must evaluate every unexpired Orange Book-listed patent associated with the reference product. A nonlisted patent may remain relevant to commercial litigation but would not necessarily trigger an ANDA certification obligation.

Which companies are associated with the commercial product?

Vivlodex was developed and commercialized through the Iroko Pharmaceuticals platform using SoluMatrix fine-particle technology. The product and associated assets have involved corporate transactions and commercial changes over time. Patent ownership, NDA ownership, and commercial distribution should be verified separately because they may not be held by the same entity.

The principal competitive groups are:

Competitive group	Product type	Patent risk
Reference-product sponsor	5 mg and 10 mg fine-particle capsules	Highest exposure to the listed and surrounding estate
Conventional generic manufacturers	7.5 mg and 15 mg meloxicam tablets	Lower direct risk if they do not copy the claimed capsule and particle profile
Low-dose capsule developers	5 mg or 10 mg meloxicam capsules	High risk if particle-size and PK profile overlap
Alternative delivery developers	Liquid, dispersible, modified-release, or noncapsule products	Potential design-around, subject to other patents
Contract manufacturers	Milling, granulation, encapsulation, and packaging	Process-patent and supply-chain exposure

What generic launch scenarios exist?

Scenario 1: Early Paragraph IV challenge

A generic applicant files an ANDA with a Paragraph IV certification against US 9,808,468 and any related listed patents. Litigation could trigger a 30-month stay of approval under the Hatch-Waxman framework, subject to statutory exceptions and litigation outcomes.

Scenario 2: Section viii carve-out

If the listed patent claims only an osteoarthritis method that can be omitted from labeling, an applicant may attempt a section viii statement. The viability of that strategy depends on the product label, the scope of the use code, and whether the remaining label still encourages the patented method.

Scenario 3: Formulation design-around

A competitor could pursue a formulation outside the claimed particle-size distribution or dissolution profile. This strategy carries development risk because changing particle size can affect exposure, bioequivalence, manufacturability, and batch consistency.

Scenario 4: Post-expiration launch

A company may wait for patent expiry and avoid litigation. This approach reduces legal cost but delays market entry and may leave the reference sponsor with substantial time to develop later-listed patents or commercial defenses.

How does US 9,808,468 compare with conventional meloxicam patents?

Conventional meloxicam products generally use higher-dose tablets, commonly 7.5 mg or 15 mg, and do not necessarily rely on the claimed nanoscale particle distribution. US 9,808,468 targets a different product concept: lower-dose capsules with faster dissolution and a defined exposure profile.

Feature	Conventional meloxicam tablet	US 9,808,468 formulation
Typical strength	7.5 mg or 15 mg	5 mg or 10 mg
Dosage form	Tablet	Capsule
Particle-size requirement	Not necessarily claimed	100-1,000 nm median, volume basis
D(0.9) requirement	Not necessarily claimed	1,200-4,000 nm
Dissolution	Product-specific	Rapid, specified USP conditions
PK limitations	Usually not defined in patent claims	AUC, Cmax, and Tmax ranges
Commercial objective	Conventional systemic exposure	Lower-dose, fine-particle exposure profile

Key Takeaways

• US 9,808,468 is a combination patent covering low-dose meloxicam capsules for osteoarthritis.
• Its central limitations are particle size, D(0.9), rapid dissolution, pharmacokinetics, and treatment method.
• The patent covers separate 5 mg fasted, 10 mg fasted, and 10 mg fed configurations.
• It does not broadly cover all meloxicam products or all nanoparticulate meloxicam formulations.
• Particle-size measurement and dissolution-test conditions are likely to be central to infringement analysis.
• Pharmacokinetic limitations create both enforcement value and potential noninfringement arguments.
• A generic applicant would need to assess Paragraph IV, section viii, formulation design-around, and later-listed patent risks.
• The patent’s ordinary term appears to extend into the 2033-2034 period, subject to confirmed USPTO patent-term adjustment and Orange Book data.
• Commercial exposure is concentrated in low-dose capsule products using fine-particle meloxicam technology.

FAQs

Does US 9,808,468 cover 7.5 mg meloxicam tablets?

No. The asserted independent claims specify 5 mg or 10 mg meloxicam in capsule form. A conventional 7.5 mg tablet would not meet those limitations.

Can a meloxicam product infringe without having the same brand name as Vivlodex?

Yes. Patent infringement depends on the claimed product and method limitations, not the brand name. A competing 5 mg or 10 mg capsule could create risk if it reproduces the claimed particle, dissolution, pharmacokinetic, and osteoarthritis-treatment profile.

Why is D(0.9) important in this patent?

D(0.9) limits the upper portion of the particle-volume distribution. It prevents a formulation from satisfying the claim based only on a nanoscale median while having an excessive coarse-particle tail.

Are the AUC and Cmax ranges bioequivalence limitations?

They are claim limitations, but they are not identical to FDA bioequivalence criteria. A product may satisfy FDA bioequivalence requirements and still require a separate patent analysis under the claimed AUC, Cmax, and Tmax ranges.

Does expiration of US 9,808,468 guarantee immediate generic launch?

No. Launch timing also depends on other unexpired patents, Orange Book certifications, litigation stays, regulatory approval, settlements, manufacturing patents, and any later-listed patents associated with the reference product.

References

1. Food and Drug Administration. (2015). Vivlodex: Prescribing information. U.S. Department of Health and Human Services.

2. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.

3. United States Patent and Trademark Office. (2017). U.S. Patent No. 9,808,468, meloxicam compositions and methods of use thereof. U.S. Department of Commerce.

4. U.S. Patent and Trademark Office. (n.d.). Patent term adjustment and patent expiration information. U.S. Department of Commerce.

5. U.S. Food and Drug Administration. (n.d.). Approved drug product list, Orange Book. U.S. Department of Health and Human Services.

Drugs Protected by US Patent 9,808,468

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Iceutica Operations	VIVLODEX	meloxicam	CAPSULE;ORAL	207233-001	Oct 22, 2015		DISCN	Yes	No						MANAGEMENT OF OSTEOARTHRITIS PAIN BY ADMINISTERING 10 MG OF MELOXICAM
Iceutica Operations	VIVLODEX	meloxicam	CAPSULE;ORAL	207233-001	Oct 22, 2015		DISCN	Yes	No						MANAGEMENT OF OSTEOARTHRITIS PAIN BY ADMINISTERING 5 MG OF MELOXICAM
Iceutica Operations	VIVLODEX	meloxicam	CAPSULE;ORAL	207233-002	Oct 22, 2015		DISCN	Yes	No						MANAGEMENT OF OSTEOARTHRITIS PAIN BY ADMINISTERING 5 MG OF MELOXICAM
Iceutica Operations	VIVLODEX	meloxicam	CAPSULE;ORAL	207233-002	Oct 22, 2015		DISCN	Yes	No						MANAGEMENT OF OSTEOARTHRITIS PAIN BY ADMINISTERING 10 MG OF MELOXICAM

International Family Members for US Patent 9,808,468

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015274838
Brazil	112016027435
Canada	2951383
China	107073010