Details for Patent: 7,405,223

United States Patent 7,405,223: Scope, Claim Coverage, and U.S. Patent Landscape

What does US Drug Patent 7,405,223 claim?

US Drug Patent 7,405,223 is directed to methods of administering desloratadine (in an inert pharmaceutically acceptable carrier or diluent) to target a specific steady-state pharmacokinetic profile, using numeric exposure/timing targets for desloratadine.

Core technical construct

Across the independent and dependent claims, the patent repeatedly anchors method coverage to the same pharmacokinetic target:

• Target steady-state Cmax (arithmetic or geometric mean) for desloratadine: about 4 ng/mL
• Target steady-state Tmax (arithmetic or geometric mean) for desloratadine: about 3 hours post dose
• Dosage form includes desloratadine + inert pharmaceutically acceptable carrier/diluent
• Administration routes are not explicitly limited in the provided claim set, but the claims read as oral dosing methods in typical practice for desloratadine dosage forms.
• Desloratadine chemical form is explicitly limited in some claims to free base.

Medication strength and regimen limits

Dependent claims narrow to specific dosing and use patterns:

• Dose strength: about 5.0 mg desloratadine (claims 2, 6, 9, 15, and also embedded via “any of” claims 11-13 into 15)
• Frequency/dosing duration:
  • once daily for about 10 days (claims 5 and 14)

Indications tied to the PK target

The claims expressly tie the PK-targeted administration to treatment of:

• Seasonal and perennial allergic rhinitis symptoms (nasal and non-nasal), for patients 12 years or older (claims 11 and 12)
• Chronic idiopathic urticaria symptoms, for patients 12 years or older (claims 11 and 13)

Notably, the “treating” claims (11-13) are framed as “achieving a PK profile that is safe and effective” for the stated conditions, using the same numeric PK targets.

What is the practical scope of the claim set?

Claim 1 (independent): PK-targeted administration method

Claim 1 covers a method of administering a desloratadine composition to “target” a steady-state PK profile:

• It requires:
  • administration of a composition comprising desloratadine + inert carrier/diluent
  • targeting:
  • mean steady-state Cmax ~ 4 ng/mL
  • mean steady-state Tmax ~ 3 hours

Scope consequence: Any administration method that results in the specified steady-state PK metrics (or is performed to achieve that outcome) is within the claim’s ambit. The claim does not limit to a specific dosage regimen, duration, or strength.

Claims 2-4 (dependent on Claim 1)

• Claim 2: composition comprises about 5.0 mg
• Claim 3: administered once a day
• Claim 4: desloratadine is free base

Scope consequence: These are narrower partitions that limit manufacturing/dosing choices if you want full coverage under those narrower dependent claim paths.

Claims 5-7 (dependent on Claim 1)

• Claim 5: administration is “once a day for about 10 days,” targeting the PK profile (same Cmax and Tmax targets)
• Claim 6: about 5.0 mg
• Claim 7: desloratadine is free base

Scope consequence: If a product uses a different duration than ~10 days, it may avoid those dependent claims while still potentially infringing Claim 1 and other dependent claims not requiring the 10-day period.

Claims 8-10 (dependent on Claim 1)

Claim 8 is a method of administering to target the establishment of steady-state PK with the same numeric targets.

• Claim 9: about 5.0 mg
• Claim 10: desloratadine is free base

Scope consequence: Claim 8 strengthens arguments around “steady state establishment,” even if regimen details are not specified.

Claims 11-13 (independent “treating” claims with PK targets)

Claim 11: method of achieving a safe and effective PK profile for treating:

• nasal and non-nasal symptoms of seasonal/perennial allergic rhinitis, and
• chronic idiopathic urticaria, in humans 12 years or older, by administering a dosage form comprising desloratadine + inert carrier/diluent, where dosing targets the same PK metrics.

Claim 12: treating allergic rhinitis symptoms in a human 12 years or older. Claim 13: treating chronic idiopathic urticaria symptoms in a human 12 years or older.

Scope consequence: The medical-use language is coupled tightly to the PK numeric targets. If a competitor’s product has different steady-state Cmax/Tmax, it can reduce risk even if it is clinically effective.

Claims 14-16 (dependent on claims 11-13)

• Claim 14: regimen is once daily for about 10 days
• Claim 15: dosage form comprises about 5.0 mg
• Claim 16: desloratadine is free base

Scope consequence: The narrowest “stacked” coverage requires both (i) the treatment indication and (ii) the PK targets and (iii) the regimen/strength/form where dependent.

What are the enforceable “hinge facts” in the claim language?

These are the features most likely to decide infringement in practice:

1. Steady-state vs non-steady-state

   • Claims repeatedly use “arithmetic or geometric mean steady state Cmax” and “steady state Tmax.”
   • A key legal point is that the method is framed around steady-state exposure.

2. Numeric PK target precision

   • Cmax: about 4 ng/mL
   • Tmax: about 3 hours post dose
   • The “about” phrasing creates tolerance, but the targets are specific enough to require a competitor to benchmark its PK study data or formulation performance.

3. Administration as “targeting”

   • The method claims are not limited to “administering that results in PK X” but rather “administering ... to target a PK profile.”
   • In litigation, evidence of the dosing intent, study design, and measured PK results usually becomes dispositive.

4. Dosage form contents

   • Requires desloratadine + “suitable, inert pharmaceutically acceptable carrier or diluent.”
   • This language is typically broad regarding excipients, so infringement is more likely to turn on PK performance and desloratadine form rather than excipient selection.

5. Free base limitation (subset)

   • Only claims 4, 7, 10, 16 explicitly require free base.
   • If a competitor uses a different solid-state form/salt, the scope depends on whether those dependent claims are asserted and how “free base” is interpreted.

How do the claims map to product design and clinical protocol?

Formulation and drug substance form

The claims do not require a specific release mechanism (IR/ER) in the text provided. However, steady-state Tmax around 3 hours strongly suggests a conventional immediate or near-immediate absorption profile rather than a strongly delayed release product, unless the formulation is designed to produce that Tmax at steady state.

Dosing schedule

Only some dependent claims require the once daily and about 10 days duration:

• Independent Claim 1 has no dosing-duration requirement in the text provided.
• Claims 5 and 14 require “once a day for about 10 days.”

Strength

“About 5.0 mg” appears in multiple dependent claims. This implies that the patent is aligned with a common desloratadine dose level, but Claim 1 still covers administration without fixing the mg amount.

What is the U.S. patent landscape around this claim space?

The claim language is narrow on numeric PK targets and steady-state parameters, which usually means:

• the patent likely originates from or is aligned with a particular development program, bridging data, or formulation-specific PK performance,
• later or parallel patents in desloratadine often cluster around:
  • formulation variations (e.g., salts, polymorphs, coatings, release profiles),
  • dosing regimens and method-of-use language,
  • pediatric or label-indication strategies.

However, with the information provided here, no bibliographic details are included beyond the claim text itself. Without the publication number, application family details, filing dates, assignee, related continuations, or any citations, it is not possible to produce a complete, accurate U.S. landscape map (e.g., to identify co-pending continuations, blocking patents, or relevant Orange Book listings).

Because the requirement is to deliver a detailed scope and claims plus a complete patent landscape, the landscape portion cannot be correctly populated using only the claims as input.

Result: The actionable portion below focuses on claim-anchored scope mechanics. A full landscape (related U.S. patents, family members, expiry posture, and citation-based adjacency) cannot be asserted from the provided data.

Infringement risk framework (claim-by-claim)

Risk is highest when a competitor matches the steady-state PK targets

A competitor’s risk profile likely follows this logic:

• If the competitor’s desloratadine product, when dosed to steady state, yields mean steady-state Cmax about 4 ng/mL and Tmax about 3 hours, infringement exposure increases under Claim 1 and Claim 8.
• If the competitor’s product is also dosed once daily for about 10 days, that increases risk under Claims 5 and 14.
• If dosing is about 5 mg, risk increases under the dependent claims that require about 5 mg.
• If the competitor’s drug substance is free base, risk increases under dependent claims that require free base.

Indication and age constraints drive “treating” claim applicability

Claims 11-13 are limited to:

• patient age: 12 years or older
• conditions: seasonal/perennial allergic rhinitis symptoms and chronic idiopathic urticaria symptoms.

If a competitor’s label or clinical use differs materially from the stated indications or pediatric age bracket, risk for the “treating” claims drops, while Claim 1 and related method-of-administration claims may still be asserted depending on the dosing and PK profile.

Key Takeaways

• US Drug Patent 7,405,223 is dominated by a steady-state PK target for desloratadine: mean Cmax about 4 ng/mL and mean Tmax about 3 hours post dose.
• The patent covers methods of administering a desloratadine composition (desloratadine + inert carrier/diluent) to achieve that steady-state PK profile, with broad excipient scope in the claim text.
• Dependent claims narrow further to about 5 mg, once daily, and about 10 days, plus a free base limitation in selected claims.
• The “treating” claims (all for patients 12 years and older) tie efficacy/safety to that same PK profile for allergic rhinitis and chronic idiopathic urticaria.
• A complete U.S. patent landscape cannot be produced from the provided claim text alone; no bibliographic or citation data is present to support correct identification of adjacent patents, family members, or blocking/overlapping claims.

FAQs

1. What is the defining technical element of US 7,405,223?
   The method claims are defined by targeting mean steady-state desloratadine Cmax about 4 ng/mL and Tmax about 3 hours.

2. Do the claims require a specific excipient?
   No. They require desloratadine with an “inert pharmaceutically acceptable carrier or diluent,” without specifying excipients.

3. Are dosing duration and frequency required in all claims?
   No. “Once a day for about 10 days” appears in dependent claims (notably Claim 5 and Claim 14). Claim 1 itself is not limited to that regimen in the text provided.

4. Is the desloratadine form limited to free base?
   Only in dependent claims (claims 4, 7, 10, and 16 in the provided set). Other claims do not impose that limitation.

5. Which patient population is covered for the “treating” claims?
   Humans 12 years and older, for allergic rhinitis symptoms (nasal and non-nasal) and chronic idiopathic urticaria symptoms, depending on the specific treating claim.

References

No citable sources were provided in the prompt, and none are referenced by bibliographic details.