Executive summary
US Drug Patent 11,154,509 claims a method of treating secondary hyperparathyroidism (SHPT) in CKD stages 3-5 using a controlled-release or sustained-release, oral dosage form of 25-hydroxyvitamin D (including 25-hydroxyvitamin D3). Claim 1 anchors broad clinical scope by requiring PTH reduction of at least 30% and recites combination co-therapy with a wide set of CKD/mineral-bone-disorder (CKD-MBD) agents and enzymes that degrade vitamin D. Dependent claims narrow to specific combination partners, and claims 14-17 introduce an exclusivity-relevant clinical constraint: avoid oversuppression of PTH defined by minimum iPTH thresholds by CKD stage.
United States Patent 11,154,509 claims scope for controlled-release 25-hydroxyvitamin D in CKD SHPT
Core claim architecture: method claims centered on (1) patient population, (2) drug identity (25-hydroxyvitamin D; optionally D3), (3) release profile (controlled-release or sustained-release), and (4) biomarker outcomes (PTH reduction and/or oversuppression avoidance).
What does the patent protect, in plain claim terms?
US 11,154,509 protects US method-of-treatment use claims that cover administering:
- To humans with CKD (explicitly Stage 3 or 4 in Claims 1-13; Stage 3-5 in Claims 14-17),
- An oral controlled-release or sustained-release dose form of 25-hydroxyvitamin D,
- To achieve SHPT control, with:
- At least 30% serum PTH reduction (Claims 1-13), and/or
- Avoiding oversuppression, with stage-specific minimum iPTH targets (Claims 14-17).
- Either as monotherapy framework (Claim 14’s structure) or in combination therapy (Claim 1 and dependent Claims 2-13).
What is “controlled release” or “sustained release” likely doing legally?
The claims are not limited to a quantified dissolution parameter in the text you provided. However, the legal effect is to distinguish from:
- immediate-release calcifediol/calcitriol products,
- non-oral routes,
- and formulations lacking a sustained exposure profile.
In practice, the “release profile” requirement is often litigated via formulation testing, dissolution, and Cmax/AUC time-course evidence. That makes formulation design-archetype a key scope lever even though the claims are not written as formulation-composition claims.
Biomarker thresholds: how tight is the clinical constraint?
Two different outcome constraints appear:
- Efficacy floor
- Claim 1: PTH reduction by at least 30%.
- Oversuppression ceiling through floor constraints
- Claim 14: avoid oversuppression while still treating SHPT.
- Claim 15 (Stage 1-3): avoid iPTH below 15 pg/mL.
- Claim 16 (Stage 4): avoid iPTH below 30 pg/mL.
- Claim 17 (Stage 5): avoid iPTH below 100 pg/mL.
These thresholds can function as clear infringement boundaries in vivo, because whether oversuppression is avoided becomes a measurable outcome.
How broadly does Claim 1 cover secondary hyperparathyroidism treatment regimens?
Claim 1 is the broadest independent claim you provided. It has several breadth drivers:
1) Patient population breadth
- Human patient with Stage 3 or 4 CKD.
- This is narrower than Claim 14-17 (which contemplate Stage 5), but still covers the common SHPT population targeted by CKD-MBD therapies.
2) Active ingredient breadth
- “a vitamin D compound consisting of 25-hydroxyvitamin D”
- Dependent Claim 13 specifies 25-hydroxyvitamin D3.
- “Consisting of” is important. It implies the vitamin D compound is essentially 25-hydroxyvitamin D, not another vitamin D analog as part of the same compound identity term. It does not necessarily exclude co-administered drugs listed in Claim 1, because those are outside the “vitamin D compound” definition.
3) Form-of-drug breadth
- Oral controlled release dosage form.
4) Efficacy breadth
- Serum PTH reduction by at least 30%. This sets a quant threshold that can be adjudicated using trial endpoints or real-world evidence if tied to the claimed method and regimen.
5) Combination breadth is extremely wide
Claim 1 requires the vitamin D compound be administered “in combination with one or more” of a long list of classes. The list spans:
- calcium salts
- bisphosphonates
- calcimimetics
- nicotinic acid
- iron
- phosphate binders
- glycemic control agents
- hypertension control agents
- antineoplastic agents
- inhibitors of CYP24
- inhibitors of other CYP enzymes that degrade vitamin D
Practical scope effect
This is not limited to CKD-MBD standard-of-care co-therapies (calcium, phosphate binders, calcimimetics, bisphosphonates). It also covers “other” comorbidity agents (glycemic control and hypertension control) and even antineoplastic agents, plus enzyme inhibition approaches (CYP24 and other CYP inhibitors).
That combination list materially increases infringement risk for:
- clinicians running SHPT regimens in multi-therapy CKD patients,
- sponsors developing 25-hydroxyvitamin D with drug-interaction strategies that use CYP inhibitors,
- and any generic attempting a “medical regimen” argument that the combination is optional, because Claim 1 text makes the combination part of the method.
What do dependent claims 2-13 specifically narrow?
Dependent claims map Claim 1’s combination breadth into specific pairing baskets.
Claim 2
- 25-hydroxyvitamin D controlled-release oral dose form + calcium salts.
Claim 3
Claim 4
Claims 5-7
-
-
-
- phosphate binders (Claim 7)
Claims 8-10
-
- glycemic control agents (Claim 8)
-
- hypertension control agents (Claim 9)
-
- antineoplastic agents (Claim 10)
Claims 11-12
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- inhibitors of CYP24 (Claim 11)
-
- inhibitors of other CYP enzymes that degrade vitamin D agents (Claim 12)
Claim 13
- specifies 25-hydroxyvitamin D comprises 25-hydroxyvitamin D3.
What these dependencies imply for claim construction
Dependent claims do not remove base elements; they add or specify. If Claim 1 is asserted, a defendant can still attempt to design around by:
- avoiding controlled-release oral dosing,
- using a vitamin D active that is not “25-hydroxyvitamin D” as the specified vitamin D compound,
- failing the ≥30% PTH reduction outcome,
- or structuring the method such that no recited “combination” is used (though Claim 1 requires “one or more,” which can be satisfied by many real-world co-therapies).
What is the oversuppression limitation in Claims 14-17 and why does it matter?
Claims 14-17 introduce a second independent anchor.
Claim 14: sustained-release + PTH oversuppression avoidance
- CKD stages: “Stage 3 or 4” is referenced in the excerpt opening for Claim 14, but the dependent claims explicitly add Stage 5 (Claims 17).
- Oral sustained release dosage form of 25-hydroxyvitamin D.
- Outcome: reduce PTH by at least 30% while avoiding oversuppression.
This “avoid oversuppression” phrase is operationalized by Claims 15-17.
Claims 15-17: stage-specific minimum iPTH floors
- Stage 1-3: avoid iPTH below 15 pg/mL.
- Stage 4: avoid iPTH below 30 pg/mL.
- Stage 5: avoid iPTH below 100 pg/mL.
Scope effect
These thresholds can be used to:
- limit infringement to regimens that maintain iPTH above the defined floors,
- create a clinical endpoint that aligns with labeling-style dose titration strategies,
- and force trial design alignment for parties seeking to defend or challenge infringement.
If a competitor’s regimen reaches the efficacy endpoint but sometimes oversuppresses below these floors, the oversuppression-avoidance claim may not be met. Conversely, a regimen that keeps iPTH above the floors supports infringement of Claims 14-17 if all other elements are met.
What design-arounds are suggested by the claim text alone?
Based on the claim language you provided, the main “knockout” levers are:
- Release profile
- Use a non-controlled-release / non-sustained-release formulation.
- Active identity
- Use a vitamin D compound that is not “25-hydroxyvitamin D.”
- (Note: a compound that is not 25-hydroxyvitamin D but is “vitamin D analog” may avoid the “consisting of 25-hydroxyvitamin D” limiter.)
- Route
- Patient stage mismatch
- For Claims 1-13: avoid treatment in Stage 3-4 CKD populations.
- For Claims 14-17: manage to stage-specific regimes without meeting the claim-defined iPTH outcomes for the relevant stage.
- Efficacy outcome
- Avoid achieving “serum PTH reduction by at least 30%” in the treated method context.
- This is harder to control during development, since efficacy is typically a primary goal.
- Combination requirement
- Claim 1 requires “in combination with one or more” of enumerated agents. Design strategies that avoid all enumerated combinations could reduce risk for Claim 1-type assertions. But because the list includes common CKD comedications (calcium salts, phosphate binders), real-world “no combination” is often hard.
- Oversuppression floors
- If pursuing defense against Claims 14-17, maintaining iPTH below the defined floors would not necessarily avoid infringement if the claim requires “avoiding oversuppression” as a method element. The claim suggests infringement requires the regimen to avoid iPTH going below those minima.
How does 11,154,509 likely interact with broader SHPT vitamin D patent families in the US?
Given the claim is method-based with controlled/sustained release and 25-hydroxyvitamin D, it typically overlaps with three adjacent US patent estate clusters in this therapeutic area:
- Vitamin D analog efficacy and dosing patents
- Earlier methods for SHPT with calcifediol or related 25-hydroxyvitamin D forms.
- These tend to cover patient cohorts and PTH outcomes, but often not the sustained-release plus “oversuppression avoidance with stage-specific iPTH floors” constraints.
- Formulation patents for oral modified-release delivery
- Controlled-release vs immediate-release embodiments often live in separate formulation patents.
- 11,154,509’s method claims can be enforced even if formulation patents are thinner, because the method requires the modified-release dosage form.
- Drug interaction and CYP degradation pathway patents
- Claim 1 includes co-administration with CYP24 inhibitors and other CYP inhibitors that degrade vitamin D.
- This overlaps with any enzyme inhibition IP around improving vitamin D exposure or preventing breakdown.
Litigation risk pattern implied by the claims
- If a product is a 25-hydroxyvitamin D controlled-release/sustained-release oral drug, method claims create exposure not only from product manufacture but also from prescribing and using.
- If a label or investigator brochure includes combination regimens with common CKD-MBD agents, that may strengthen enforcement narratives around “combination with one or more” listed classes.
Key scope table: what each claim requires
| Claim |
CKD stage scope (per provided text) |
Vitamin D active |
Release/profile |
Efficacy requirement |
Combination requirement |
Oversuppression constraint |
| 1 |
Stage 3-4 |
25-hydroxyvitamin D |
Controlled-release oral |
≥30% serum PTH reduction |
Yes, with ≥1 enumerated class |
Not included |
| 2 |
Stage 3-4 |
25-hydroxyvitamin D |
Controlled-release oral |
Not separately stated (depends on claim 1) |
With calcium salts |
No |
| 3 |
Stage 3-4 |
25-hydroxyvitamin D |
Controlled-release oral |
Depends |
With bisphosphonates |
No |
| 4 |
Stage 3-4 |
25-hydroxyvitamin D |
Controlled-release oral |
Depends |
With calcimimetics |
No |
| 5 |
Stage 3-4 |
25-hydroxyvitamin D |
Controlled-release oral |
Depends |
With nicotinic acid |
No |
| 6 |
Stage 3-4 |
25-hydroxyvitamin D |
Controlled-release oral |
Depends |
With iron |
No |
| 7 |
Stage 3-4 |
25-hydroxyvitamin D |
Controlled-release oral |
Depends |
With phosphate binders |
No |
| 8 |
Stage 3-4 |
25-hydroxyvitamin D |
Controlled-release oral |
Depends |
With glycemic control agents |
No |
| 9 |
Stage 3-4 |
25-hydroxyvitamin D |
Controlled-release oral |
Depends |
With hypertension control agents |
No |
| 10 |
Stage 3-4 |
25-hydroxyvitamin D |
Controlled-release oral |
Depends |
With antineoplastic agents |
No |
| 11 |
Stage 3-4 |
25-hydroxyvitamin D |
Controlled-release oral |
Depends |
With CYP24 inhibitors |
No |
| 12 |
Stage 3-4 |
25-hydroxyvitamin D |
Controlled-release oral |
Depends |
With other CYP inhibitors degrading vitamin D |
No |
| 13 |
Stage 3-4 |
25-hydroxyvitamin D3 |
Controlled-release oral |
Depends |
Depends on claim 1 combination |
No |
| 14 |
CKD stages referenced: Stage 3-4 in excerpt; intent extends via deps |
25-hydroxyvitamin D |
Sustained-release oral |
≥30% PTH reduction |
Not enumerated in excerpt |
Yes, avoid oversuppression |
| 15 |
Stage 1-3 |
25-hydroxyvitamin D |
Sustained-release oral |
Depends on claim 14 |
Not enumerated |
Avoid iPTH < 15 pg/mL |
| 16 |
Stage 4 |
25-hydroxyvitamin D |
Sustained-release oral |
Depends |
Not enumerated |
Avoid iPTH < 30 pg/mL |
| 17 |
Stage 5 |
25-hydroxyvitamin D |
Sustained-release oral |
Depends |
Not enumerated |
Avoid iPTH < 100 pg/mL |
Competitive and licensing implications for US 11,154,509 (based on claim scope)
For originators or label holders
- The claim language supports enforcement through combination therapy use and modified-release dosing.
- The oversuppression constraints (15-17) suggest value in clinical differentiation and may support market exclusivity narratives even if competitors copy the active ingredient.
For generics and biosimilar-adjacent developers (small molecule generic context)
- The most relevant risk is not just product identity; it is:
- matching the modified-release profile,
- achieving the claimed ≥30% PTH reduction in the method context,
- and, depending on asserted claim, either satisfying the enumerated combination requirement (Claim 1 family) or meeting the oversuppression avoidance floors (Claim 14 family).
For combination-product or co-therapy strategies
- Because Claim 1 includes a broad set of co-medications, “background therapy” is part of infringement calculus.
- If co-therapy is standard in CKD SHPT management, the claim can be asserted even when a competitor’s product is used in real-world regimens that include common calcium/phosphate/calcimimetic use.
What is missing for full “patent landscape” mapping (and why this response stays scoped to claim language)
This response is limited strictly to the claim scope you provided. A full landscape analysis typically requires the patent’s bibliographic data (title/assignee/continuity), claim set beyond what’s quoted, and the prosecution and family members. Without that, a litigation-strength and expiration-date analysis cannot be produced accurately.
Key Takeaways
- US 11,154,509 protects method-of-use for SHPT in CKD stages 3-4 using oral controlled-release 25-hydroxyvitamin D to achieve ≥30% PTH reduction, with combination co-therapy covering calcium, phosphate binders, calcimimetics, bisphosphonates, comorbidity agents, and CYP24/CYP inhibitors.
- A second independent method track requires sustained-release 25-hydroxyvitamin D to reduce PTH ≥30% while avoiding oversuppression, operationalized as stage-specific iPTH floors: 15 pg/mL (Stage 1-3), 30 pg/mL (Stage 4), 100 pg/mL (Stage 5).
- The combination list in Claim 1 materially increases real-world enforcement exposure because many listed partners are common in CKD-MBD management.
FAQs
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Does Claim 1 require all listed co-therapies or just one?
It requires “one or more” of the enumerated agents, so satisfying any single listed combination element can meet the claim structure.
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Can a competitor avoid infringement by using immediate-release 25-hydroxyvitamin D?
Based on the claim text, changing from controlled/sustained release to immediate-release is a core potential design-around because release profile is an express method element.
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How are “oversuppression” and infringement tied in Claims 14-17?
Oversuppression is defined by avoiding iPTH below stage-specific thresholds (15, 30, and 100 pg/mL), making measured iPTH outcomes central to the method.
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Are the CKD stage ranges different between the claim sets?
Claims 1-13 are expressly aimed at Stage 3-4 CKD in your excerpt; Claims 14-17 add stage-specific oversuppression limits and explicitly include Stage 5 via Claim 17.
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Do the enzyme-inhibition co-therapies (CYP24 inhibitors, CYP inhibitors) expand the combination universe beyond standard SHPT agents?
Yes. Claim 1 expressly includes those enzyme inhibitors, which broadens method coverage to regimens that combine 25-hydroxyvitamin D with vitamin D degradation pathway inhibition.
