United States Patent 8,969,569: Delafloxacin Meglumine Composition Claims, Expiration, and Patent Landscape

U.S. Patent No. 8,969,569 protects pharmaceutical compositions containing delafloxacin meglumine with specified excipient classes, crystalline-form characteristics, purity parameters, and oral dosage-form configurations. It also covers methods of treating bacterial infections in mammals and fish using those compositions. The patent does not claim delafloxacin meglumine as a standalone chemical compound.

The principal commercial relevance is to oral delafloxacin products, including Baxdela tablets. A product containing delafloxacin meglumine and the claimed excipient combination may implicate the patent even when the manufacturer uses a different tablet strength, manufacturing process, or excipient grade.

What drug does U.S. Patent 8,969,569 protect?

The active pharmaceutical ingredient identified in the claims is delafloxacin meglumine, also known as the meglumine salt of delafloxacin. Delafloxacin is a fluoroquinolone antibacterial marketed in the United States as Baxdela by Melinta Therapeutics.

The chemical name in the claims is a systematic description of delafloxacin meglumine:

Delafloxacin: a fluoroquinolone antibacterial containing a chlorinated and fluorinated quinolone core.
Meglumine: the D-glucitol, 1-deoxy-1-(methylamino) counterion identified in the claims.
Claimed product form: a salt incorporated into a pharmaceutical composition.

The patent focuses on formulation and therapeutic-use protection rather than basic compound protection. The independent claims require a composition containing delafloxacin meglumine and specific functional excipient categories.

What are the independent claims in U.S. Patent 8,969,569?

The patent has four principal independent claims: claims 1, 21, 23, and 34.

Claim	Claim type	Core requirements
1	Composition	Delafloxacin meglumine plus filler, binder, disintegrant, buffering agent, and lubricant
21	Narrow composition	Delafloxacin meglumine, cellulose, povidone, crospovidone, sodium phosphate salt, and magnesium stearate
23	Treatment method	Treating bacterial infection in fish or mammals with a composition containing delafloxacin meglumine and the five excipient categories
34	Narrow treatment method	Treating bacterial infection with delafloxacin meglumine, cellulose, povidone, crospovidone, sodium phosphate salt, and magnesium stearate

Claim 1 is the broadest composition claim. It does not require a particular tablet strength, dosage, crystalline form, purity level, or route of administration. It requires the presence of five excipient functions:

At least one filler.
At least one binder.
At least one disintegrating agent.
At least one buffering agent.
At least one lubricant.

Claims 21 and 34 replace functional categories with named or narrowly defined materials. They are narrower but may be easier to evaluate against a commercial tablet formulation.

How broad is claim 1?

Claim 1 has substantial formulation breadth because it uses functional excipient categories rather than limiting the formulation to a single named recipe.

A formulation may fall within claim 1 if:

Delafloxacin meglumine is present.
The formulation contains at least one material performing each required excipient function.
The composition is therapeutic in nature.

The claim does not expressly require:

An oral tablet.
A specific dosage strength.
A particular release profile.
A particular delafloxacin-to-meglumine ratio.
A specific crystalline form.
A stated crystalline purity.
A specified chemical purity.
A particular manufacturing process.
A particular bacterial species.
A particular patient population.

The use of “at least one” expands the claim. A single ingredient may potentially perform more than one excipient function, depending on the factual record and claim construction. For example, a material may have both binding and disintegrating properties. Whether one ingredient satisfies multiple limitations would depend on technical evidence, the specification, and the prosecution history.

The principal limitation is that the claim is composition-specific. Delafloxacin meglumine alone, an injectable solution lacking the claimed solid-dose excipient structure, or a formulation without a qualifying buffer would not literally meet all limitations of claim 1.

What formulations are protected by the dependent claims?

The dependent claims add four main categories of limitations: crystalline form, purity, dosage form, and excipient identity.

Crystalline-form limitations

Claims 3 through 7 address crystalline delafloxacin meglumine.

Claim 5 requires at least about 95% crystalline purity. Claim 6 identifies the crystalline form by an X-ray powder diffraction pattern shown in Figure 1. Claim 7 describes the form using lattice parameters:

a: approximately 16.4460 Å
b: approximately 21.4010 Å
c: approximately 5.3050 Å
β: approximately 109°
Crystal system: monoclinic
Space group: P21/C or P21/M
Measurement condition: approximately 25°C with Mo-Kα radiation

Claim 6 is pattern-based. Claim 7 is parameter-based. A formulation can potentially fall within claim 3 without meeting claims 6 or 7 if it contains crystalline delafloxacin meglumine but does not satisfy the particular diffraction or lattice-parameter limitations.

Chemical-purity limitations

Claims 8 through 11 require substantial chemical purity, including:

Approximately 97% chemical purity.
Approximately 98% chemical purity.
Approximately 100% chemical purity.

These limitations may create factual disputes because “about” and “substantial chemical purity” require interpretation in the context of the specification, analytical method, impurity profile, and prosecution record.

Oral dosage-form limitation

Claim 12 limits the composition to an orally administered dosage form. Tablets and capsules are the most commercially relevant forms. The claim does not expressly require immediate release, although the excipient combination is consistent with a conventional oral solid dosage form.

Named-excipient limitations

Claims 13 through 20 identify the following materials:

Function	Claimed material
Filler	Cellulose
Binder	Povidone
Disintegrant	Crospovidone
Buffer	Sodium phosphate salt or citrate
Lubricant	Magnesium stearate

Claim 19 combines cellulose, povidone, crospovidone, sodium phosphate salt, and magnesium stearate. Claim 20 adds a citrate to that combination.

Claims 21 and 22 restate the same general combination as an independent and dependent composition structure. These claims are narrower than claim 1 because they require the named ingredients rather than merely ingredients performing the specified functions.

Does U.S. Patent 8,969,569 cover Baxdela tablets?

The patent is directly relevant to oral Baxdela tablets because the claims target delafloxacin meglumine combined with conventional oral solid-dose excipients. The FDA-approved Baxdela labeling identifies delafloxacin meglumine as the active ingredient and describes oral tablets and intravenous formulations (FDA, 2023).

A literal infringement analysis would require comparison of the commercial product’s complete qualitative formulation against each claim limitation. Key questions include:

Whether the product contains delafloxacin meglumine in the claimed salt form.
Whether microcrystalline cellulose qualifies as the claimed cellulose filler.
Whether povidone is used as a binder.
Whether crospovidone is used as the disintegrant.
Whether a sodium phosphate salt or citrate is present as a buffering agent.
Whether magnesium stearate is present as a lubricant.
Whether the product’s crystalline form and purity meet claims 3 through 11.

The presence of an additional excipient generally would not avoid claim 1 because the claim does not exclude other ingredients. A formulation can contain additional coating agents, glidants, stabilizers, or processing aids and still satisfy the claim.

The absence of one required excipient category could be more significant. For example, a tablet with delafloxacin meglumine, cellulose, povidone, crospovidone, and magnesium stearate but no qualifying buffering agent would present a potential defense to literal infringement of claim 1, subject to whether another ingredient performs the buffering function.

What methods of treatment does the patent protect?

Claims 23 through 35 cover methods of treating bacterial infection in a fish or mammal.

The method claims require:

A bacterial infection.
A fish or mammalian subject.
Administration of a composition containing delafloxacin meglumine.
The claimed excipient structure.
A therapeutically acceptable amount.

Claim 25 specifies a dosage range of approximately 0.03 to 200 mg/kg body weight. Claims 26 through 33 add the same excipient limitations found in the composition claims.

Claim 24 narrows claim 23 to a mammal. The mammalian scope can include human and nonhuman mammals unless the patent or prosecution history imposes a narrower interpretation. The inclusion of fish is commercially distinctive and broadens the veterinary-use dimension of the patent.

The method claims do not claim treatment with delafloxacin meglumine in every possible dosage form. They require administration of the claimed composition. A method using a different delafloxacin formulation may fall outside the literal scope of claims 23 and 34 even if the active ingredient and disease indication are the same.

When does U.S. Patent 8,969,569 lose exclusivity?

The patent was issued on March 3, 2015. Its underlying application claims priority to an earlier filing, and the ordinary patent term is measured from the relevant nonprovisional filing date under the modern 20-year patent-term framework (USPTO, 2024).

The expected nominal expiration is in 2031, subject to any applicable patent-term adjustment, terminal disclaimer, patent-term extension, or other term calculation reflected in the official USPTO record. FDA-listed patent expiration dates, where applicable, should be distinguished from the end of FDA regulatory exclusivity.

The patent does not create NCE exclusivity by itself. Delafloxacin received FDA approval in 2017, and the product’s separate regulatory exclusivity depended on the NDA approval and statutory designations. QIDP designation can provide priority review and a five-year extension to qualifying patent or regulatory periods, but it is not the same as a separate five-year period of market exclusivity (FDA, 2018).

What is the Orange Book status of the patent?

The Orange Book is the relevant FDA source for patents submitted with an approved small-molecule drug application. Listed patents can include composition, formulation, method-of-use, and drug-substance patents. The Orange Book does not determine infringement or validity. It identifies patents that may require certification in an ANDA filing (FDA, 2024).

For delafloxacin products, the regulatory analysis should separate:

Issue	Relevance
Listed patent	Determines whether an ANDA applicant may need a Paragraph I, II, III, or IV certification
Patent expiration	Determines the end of the listed patent’s term
Use code	Defines the approved method-of-use scope associated with a method patent
Dosage form	Determines whether the patent is relevant to tablets, injection, or both
NDA product	Establishes which approved product the patent listing covers

A patent directed to oral composition architecture may be more relevant to a generic tablet than to an intravenous delafloxacin product. A generic sponsor can seek approval for a dosage form or indication that avoids a listed use patent, but formulation claims can remain relevant even when the sponsor uses a different label strategy.

Which companies are challenging the patent?

A Paragraph IV challenge requires an ANDA applicant to assert that a listed patent is invalid, unenforceable, or not infringed. Public confirmation of a challenge requires an FDA Paragraph IV notice, a district-court complaint, or another authoritative litigation record.

The claim set creates several potential design-around and challenge positions:

The proposed product does not contain delafloxacin meglumine.
The salt is present but the required excipient function is absent.
A different buffer is used.
A different lubricant is used.
The product is an injectable rather than an oral solid dosage form.
The crystalline form does not meet claims 3 through 7.
The formulation does not meet the purity limitations.
The asserted claim is indefinite or lacks written-description support.
The claimed combination is obvious over delafloxacin salt, conventional tablet excipients, and known fluoroquinolone formulation techniques.
The method claim is not infringed because the proposed label does not direct use of the claimed composition.

No conclusion on a specific company’s Paragraph IV position should be drawn solely from the existence of an ANDA or a patent listing. A litigation docket and Paragraph IV notice are required to establish an actual challenge.

How strong is the patent estate for delafloxacin?

U.S. Patent 8,969,569 is strongest against a generic tablet that closely reproduces the commercial formulation. Its principal strengths are:

It covers the active salt in a composition rather than requiring a specific brand name.
Claim 1 uses broad functional excipient categories.
The claims cover both compositions and treatment methods.
The dependent claims provide multiple fallback positions based on crystalline form, purity, and named excipients.
The patent reaches mammalian and fish treatment methods.

Its principal vulnerabilities are:

The patent does not claim delafloxacin meglumine as a chemical entity in isolation.
The composition claims require a multi-excipient architecture.
The named-excipient claims can be avoided by changing the formulation.
Crystal-form limitations may require detailed analytical evidence.
Conventional excipient combinations may face obviousness arguments.
The breadth of “about,” “substantial,” and functional excipient terms may create claim-construction issues.
A generic applicant may pursue an alternative formulation or dosage form.

What generic launch scenarios exist?

Launch scenario	Patent risk
Tablet reproducing the commercial excipient profile	High risk under claims 1, 19, and 21
Tablet using delafloxacin meglumine but replacing the buffer	Lower literal risk, subject to functional equivalence
Tablet using a different salt	Potentially outside these claims, depending on salt identity and claim construction
Intravenous formulation	Lower relevance to oral-dosage claims; method claims require separate analysis
Tablet using a different disintegrant or lubricant	May avoid named-excipient claims but not necessarily claim 1
Product with a different crystalline form	Potentially avoids crystal-specific claims but not all composition claims
Veterinary product using the claimed formulation	Directly relevant to claims 23 through 35

The strongest design-around strategy would change one or more required excipient functions while preserving acceptable dissolution, stability, manufacturability, and bioequivalence. That strategy may create regulatory development costs and could raise infringement issues under the doctrine of equivalents.

Does the patent create biosimilar risk?

No. Delafloxacin is a small-molecule antibacterial, not a biologic. The relevant follow-on pathway is an ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act, not a biosimilar application under the Public Health Service Act.

The commercial risk is generic substitution, Paragraph IV litigation, patent-term timing, and formulation design-around. Biosimilar interchangeability rules do not apply.

Key Takeaways

U.S. Patent 8,969,569 covers delafloxacin meglumine formulations containing a filler, binder, disintegrant, buffering agent, and lubricant.
The patent is highly relevant to oral delafloxacin tablets, including products using cellulose, povidone, crospovidone, sodium phosphate, and magnesium stearate.
Claims 3 through 7 add crystalline-form limitations, while claims 8 through 11 add chemical-purity limitations.
Claims 23 through 35 cover treatment of bacterial infection in mammals and fish with the claimed compositions.
The patent does not claim delafloxacin meglumine as a standalone compound.
A generic tablet that changes the buffer, disintegrant, lubricant, or crystalline form may reduce literal infringement risk.
The expected nominal patent term extends into 2031, subject to the official term calculation and any applicable adjustment.
Delafloxacin is a small molecule, so generic competition proceeds through the ANDA pathway rather than the biosimilar pathway.
The commercial exposure is greatest for oral tablets that reproduce the Baxdela formulation architecture.

FAQs

Does U.S. Patent 8,969,569 cover delafloxacin itself?

No. The claims cover delafloxacin meglumine in specified pharmaceutical compositions and methods of treatment. They do not independently claim the active molecule as an unformulated chemical compound.

Can a generic avoid the patent by using delafloxacin potassium instead of delafloxacin meglumine?

Potentially. The claims expressly identify the meglumine salt. A different salt may avoid literal infringement, although the full patent family, other listed patents, regulatory requirements, and doctrine-of-equivalents issues must be evaluated separately.

Are crystal-form claims 6 and 7 necessary to infringe claim 1?

No. Claim 1 does not require the specific crystalline form. A product can potentially infringe claim 1 without meeting the limitations of claims 6 or 7 if it contains the required delafloxacin meglumine composition and excipient categories.

Does adding extra excipients avoid infringement?

Usually not by itself. The claims require specified ingredients or functions but do not generally prohibit additional excipients. An added coating agent, glidant, stabilizer, or processing aid would not automatically remove a product from the claim scope.

Is a veterinary delafloxacin product covered?

It may be. Claims 23 through 35 expressly cover treatment of bacterial infection in fish or mammals, subject to the required delafloxacin meglumine composition and excipient limitations.

References

U.S. Patent No. 8,969,569. (2015). Pharmaceutical compositions comprising delafloxacin meglumine. United States Patent and Trademark Office.
U.S. Food and Drug Administration. (2023). Baxdela (delafloxacin meglumine) prescribing information. FDA.
U.S. Food and Drug Administration. (2018). Qualified infectious disease product designation. FDA.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. FDA.
United States Patent and Trademark Office. (2024). Patent term adjustment and patent term expiration guidance. USPTO.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2582954	⤷ Start Trial
Cyprus	1125048	⤷ Start Trial
Denmark	3056492	⤷ Start Trial
European Patent Office	1802607	⤷ Start Trial
European Patent Office	3056492	⤷ Start Trial
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Details for Patent: 8,969,569

Summary for Patent: 8,969,569