Details for Patent: 12,551,483

Which drugs does patent 12,551,483 protect, and when does it expire?

Patent 12,551,483 protects ROMVIMZA and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 12,551,483

Title:	Formulations of vimseltinib
Abstract:	Described herein, in part, are pharmaceutically acceptable formulations comprising a compound represented by Formula (I) and methods of preparing and using the formulations:
Inventor(s):	Ehab Hamed
Assignee:	Deciphera Pharmaceuticals LLC
Application Number:	US19/295,254
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form;

United States Patent 12,551,483: What the Claims Actually Cover and How the Patent Landscape Likely Reads

What is the claim scope of US Drug Patent 12,551,483?

US Drug Patent 12,551,483 is a formulation-and-solid-state patent. The claim core is a crystalline dihydrate (solid-state dihydrate) of a compound of Formula (I), paired with specific oral dosage compositions and performance criteria (dissolution, particle/crystal form control by XRPD, and formulation excipient ranges). The claims are drafted to limit both what form of the drug is used and how it is processed into dose units.

Key claim elements shared across the independent claim set

Across the main claim types (oral dosage forms and capsules), the common mandatory elements are:

• Active solid form: a crystalline dihydrate (or “solid-state dihydrate”) of compound of Formula (I)
• Solid-state identity by XRPD:
  • Must show peaks at 2-theta about 10.9°, 16.8°, and 27.1° (CuKα)
  • Dependent claims also add an expanded peak set including 5.9°, 11.9°, 13.7°
• Form performance:
  • In claim 1 specifically: >90% released in 30 minutes by USP <711> Apparatus 2 (paddles)
• Excipients:
  • Oral formulation claims specify ranges for filler (lactose monohydrate), cross-linked PVP (crospovidone or equivalent), and lubricant(s)
• Form control limits:
  • Dependent claims cap the amount of other polymorphic/crystalline forms lacking the stated XRPD peaks (mol % thresholds)

Independent claim 1: Oral dosage form with XRPD-defined crystalline dihydrate + dissolution

Claim 1 is the broadest “oral dosage form” concept in your excerpt because it includes: 1) Oral dosage form containing a crystalline dihydrate of Formula (I)
2) XRPD identity constraint (peaks at ~10.9°, 16.8°, 27.1°)
3) Quantified drug content by strength in the oral dose:

• about 15.2 mg, about 21.7 mg, about 32.5 mg 4) Excipients in narrow functional ranges:
• Lactose monohydrate: ~20% to ~97% w/w
• Cross-linked polyvinylpyrrolidone: ~1% to ~20% w/w
• Lubricant(s): ~0.1% to ~10% w/w 5) Dissolution release criterion:
• >90% released in 30 minutes (USP <711>, Apparatus 2) 6) Crystal purity by XRPD identity:
• The dependent claims 2 to 5 add mol% caps on “other crystalline forms” not matching the XRPD peaks.

Practical implication: an “infringing” product must match both:

• the dihydrate solid-state fingerprint, and
• the formulation architecture (filler/disintegrant cross-linked PVP/lubricant ranges),
• plus the release behavior.

Claims 2 to 5: Crystal purity gating (mol % thresholds)

Claim 2-5 limit the presence of other crystalline forms lacking the specified peaks.

• Claim 2: ≤ ~10 mol% of other crystalline forms
• Claim 3: ≤ ~5 mol%
• Claim 4: ≤ ~3 mol%
• Claim 5: ≤ ~1 mol%

Practical implication: even if a competitor uses the correct “dihydrate” but has more than these allowed levels of other crystalline forms, it can fall outside these dependent claim boundaries. For strategy, this means the enforceable scope hinges on how much polymorphic impurity exists in commercial manufacturing.

Claims 6 to 10: Additional characterization anchors

These claims are characterization-dependent and used to tighten claim construction to a specific material identity:

• Claim 6: XRPD “substantially as shown in FIG. 1”
• Claim 7: DSC thermogram constraints:
  • endothermic onset ~75°C to ~95°C
  • exothermic onset ~123°C to ~150°C
  • endothermic peak ~215°C
• Claim 8: DSC “substantially as shown in FIG. 2”
• Claim 9: TGA “substantially as shown in FIG. 3”
• Claim 10: XRPD expands peak list:
  • ~5.9°, 10.9°, 11.9°, 13.7°, 16.8°, 27.1°

Practical implication: the patent is built to defend against “identity” workarounds where a rival tries to argue that the dihydrate is “similar” but not the same.

Claim 11: Alternate excipient range emphasis (lactose 80-90%)

Claim 11 narrows excipient structure to:

• lactose monohydrate ~80% to ~90% w/w
• cross-linked polyvinylpyrrolidone ~1% to ~10% w/w
• lubricants ~0.1% to ~3% w/w

This claim is a “sweet spot” narrower than claim 1, giving the patentee fallback positions.

Claims 12 to 17: Capsule scope with stability requirement

Claims 12 to 17 shift from tablets/oral dosage to capsules and add:

• a defined stable pharmaceutical composition concept for 24 months,
• specific capsule strength targets:
  • to provide about 2 mg, 10 mg, 14 mg, 20 mg, or 30 mg of free base.

Claim 12 also requires the XRPD signature (peaks ~10.9°, 16.8°, 27.1°).

Excipients in capsules:

• Claim 13: disintegrants ~1% to ~20% w/w + lubricants ~0.1% to ~10% w/w
• Claim 14: disintegrants ~1% to ~10% w/w + lubricants ~0.1% to ~3% w/w
• Claim 15: explicitly allows cross-linked polyvinylpyrrolidone ~1% to ~10% w/w
• Claim 16: XRPD expanded peak list (5.9°, 10.9°, 11.9°, 13.7°, 16.8°, 27.1°)
• Claim 17: XRPD “substantially as shown in FIG. 1”

Practical implication: this is not just a “form type” patent. It also claims stability over 24 months, which can be a strong differentiation point for commercial formulation design and could be used in enforcement/validity arguments relating to amorphous uptake, hydration loss, or polymorphic transformation under real storage.

Claim 18: Oral dosage form with free base or salt + strength list + fixed solid-state XRPD

Claim 18 adds additional flexibility compared with claim 1 because it covers:

• the compound in free base form or a pharmaceutically acceptable salt, but still must be crystalline dihydrate.

It also includes dose strength targets (2, 10, 14, 20, 30 mg free base equivalents) and sets excipients as:

• filler ~20% to ~97% w/w
• disintegrant ~1% to ~20% w/w
• lubricants ~0.1% to ~10% w/w
• XRPD peaks ~10.9°, 16.8°, 27.1°

So, claim 18 is a broad “salt/free base, dihydrate, oral dosage architecture” claim that can capture products that use salts rather than the free base, as long as the dihydrate solid-state is used.

Claims 19 to 24: Oral dosage quality/ingredient specifics

• Claim 19: acceptance value <15 according to USP <905>
• Claim 20: lubricant is magnesium stearate
• Claim 21: filler is lactose monohydrate
• Claim 22: XRPD expanded peak list (5.9°, 10.9°, 11.9°, 13.7°, 16.8°, 27.1°)
• Claim 23: XRPD “substantially as shown in FIG. 1”
• Claim 24: narrows composition:
  • filler ~80% to ~90% w/w
  • disintegrant ~1% to ~10% w/w
  • lubricants ~0.1% to ~3% w/w

Practical implication: these dependent claims map to standard oral solid form optimization knobs: particle size/flow and blending acceptance, specific lubricant selection, and lactose selection.

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Where is the patent likely strongest in enforcement?

Strength comes from “stacked” limitations: drug form identity + quantitative dissolution + formulation ranges.

1) The solid-state dihydrate fingerprint (XRPD)

The repeated XRPD requirement:

• peaks at ~10.9°, 16.8°, 27.1° (CuKα)

and the expanded peak set:

• ~5.9°, 10.9°, 11.9°, 13.7°, 16.8°, 27.1° (CuKα)

creates a high-value evidentiary target for enforcement. Competitor products must either:

• produce the same dihydrate crystal form, or
• show that their product does not meet the XRPD peak criteria (including “substantially as shown” dependents).

2) Dissolution performance (USP <711>, App. 2)

Claim 1 requires:

• >90% released in 30 minutes.

That ties formulation microstructure and excipient selection to the legal scope. Even if XRPD identity is met, failure on the dissolution target can provide a non-infringement argument for products aiming for slower release or different mechanical disintegration profiles.

3) Capsule stability (24 months)

Claim 12 has a “means for making the composition substantially stable for 24 months.” That is a formulation/process performance anchor. It tends to be hard to “design around” without re-engineering excipients, moisture control, and packaging.

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What is the likely patent landscape around this type of claim strategy?

Without the full file history or the identity of “compound of Formula (I),” the landscape read must focus on typical US practice patterns for crystalline form and formulation patents, and on how the claim structure tends to relate to earlier patents covering:

• the API (compound of Formula (I)),
• generic compositions,
• and earlier polymorph disclosures.

Typical layering pattern

For US crystalline dihydrate + oral dosage patents like this, landscapes generally cluster into three blocks:

1. Composition-of-matter for the compound (Formula I itself)

   • Usually earlier.
   • If those claims exist and are still in force, they drive long runway of exclusivity.

2. Crystalline form patents (new polymorphs/solvates/hydrates)

   • This patent is in that bucket.
   • The value is in the XRPD/DSC/TGA identity and in purity and transformation stability.

3. Formulation and performance patents

   • This patent includes oral dosage excipient ranges and dissolution and capsule stability.
   • Often these follow API crystallinity to secure additional exclusivity around commercial dosage formats.

Landscape “attack surfaces” and how competitors usually respond

Competitors who want market entry typically attempt one or more of the following:

• Solid form change: switch to a different polymorph/anhydrate/solvate to avoid XRPD match.
• XRPD purity control: if the product includes the claimed dihydrate but exceeds mol% limits of non-matching crystalline forms, it may avoid dependents 2-5.
• Dissolution behavior tuning: adjust disintegrant level, lubricant selection, and processing so they do not meet “>90% in 30 minutes.”
• Salt vs free base strategy: they must still satisfy “crystalline dihydrate” to land inside claim 18; avoiding dihydrate avoids the salt/free-base ambiguity.

This patent’s claim construction makes it hard to rely on a single change because multiple constraints are layered in the independent claims.

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How do the claims map to non-infringement design choices?

Design choice A: Use a different hydrate/polymorph

If the XRPD peaks at ~10.9°, 16.8°, 27.1° are absent or shifted beyond “substantially,” the product can avoid the XRPD-based identity requirements.

Design choice B: Use the same dihydrate but fail dissolution

If the product does not show >90% released in 30 minutes (USP <711>, App. 2), claim 1’s dissolution limitation can be a clean non-infringement route for oral dosage products, even if the dihydrate matches XRPD.

Design choice C: Keep dihydrate but exceed “other crystalline form” thresholds

Claims 2-5 cap impurity by mol%. If manufacturing introduces enough non-matching crystalline forms, the dependents might be avoided. Note that avoiding dependent claims does not automatically avoid independent claim 1 unless the impurity affects the ability to prove the core crystalline dihydrate meets the XRPD requirement.

Design choice D: Move to a formulation outside excipient ranges

Independent claim 1 and claim 18 include wide filler ranges and mid-range disintegrant and lubricant ranges. A competitor can attempt to:

• change lactose level outside claim 1/18,
• or change cross-linked PVP/disintegrant level outside the listed window.

However, claim 11/24 and claims 13/14/15 also leave narrower windows, so the landscape becomes a “range-by-range” analysis.

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What is the commercial scope implied by the claim strengths and dose targets?

The dosage strengths listed show multiple commercial dose options tightly coupled to the claimed dihydrate:

• Oral dosage strengths for claim 1: 15.2 mg, 21.7 mg, 32.5 mg
• Capsules/free base equivalents for claim 12: 2, 10, 14, 20, 30 mg
• Oral dosage strengths for claim 18: 2, 10, 14, 20, 30 mg

That pattern implies the dihydrate is used across a dose range, not just a single strength. From a landscape viewpoint, it reduces the value of “strength carve-outs” because multiple strengths are covered within the same solid-form and composition frameworks.

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Where are the claim redundancies that strengthen validity arguments?

The patent repeats the same XRPD fingerprint across:

• independent claims (1 and 18, and claim 12),
• multiple dependents (6, 10, 16, 17, 22, 23),
• and alternates via expanded peak sets (5.9°, 10.9°, 11.9°, 13.7°, 16.8°, 27.1°).

It also anchors to thermal and gravimetric evidence through DSC and TGA dependents (claims 7-9). That redundancy is typical when applicants anticipate identity and enablement challenges against polymorph patents.

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Key Takeaways

• US 12,551,483 is a crystalline solid-state dihydrate + oral/capsule formulation patent, not a broad compound-use patent.
• The enforceable core is the XRPD dihydrate identity (peaks at ~10.9°, 16.8°, 27.1°, CuKα), layered with excipients ranges and (for claim 1) dissolution performance (>90% in 30 minutes, USP <711> App. 2).
• Dependent claims add crystal-purity thresholds (≤ 10/5/3/1 mol% other crystalline forms without the XRPD peaks), plus DSC/TGA and “substantially as shown in FIG.” constraints.
• Capsule claims add a 24-month stability framing and multiple strength targets, reducing design-around opportunities via simple packaging/form.
• The likely competitive pressure points are avoiding the specific dihydrate XRPD, failing the dissolution endpoint, and managing solid-state impurity and stability under real storage.

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FAQs

1) Does the patent cover both free base and salts?

Yes. Claim 18 explicitly covers the compound in free base or a pharmaceutically acceptable salt, as long as the material is still in the crystalline dihydrate form.

2) What test controls claim 1’s performance requirement?

Claim 1 requires >90% release in 30 minutes measured by USP <711>, Apparatus 2 (paddles).

3) Which XRPD peaks are the core identity markers?

The core XRPD requirement is peaks at about 10.9°, 16.8°, and 27.1° (CuKα).

4) Can a competitor avoid dependent claims 2-5 by allowing more polymorphic impurity?

Dependent claims 2-5 cap “other crystalline forms” at ≤10/5/3/1 mol%. Exceeding those caps can avoid those dependent claim positions, though independent claims still require the core dihydrate XRPD identity.

5) Is capsule stability part of the claimed scope?

Yes. Claim 12 includes a “means for making the composition substantially stable for 24 months,” alongside the dihydrate XRPD fingerprint and dosage strength targets.

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References

[1] User-provided claims text for US Drug Patent 12,551,483 (claims 1-24 as quoted).

Drugs Protected by US Patent 12,551,483

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304-001	Feb 14, 2025		RX	Yes	No	12,551,483		Y
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304-002	Feb 14, 2025		RX	Yes	No	12,551,483		Y
Deciphera Pharms	ROMVIMZA	vimseltinib	CAPSULE;ORAL	219304-003	Feb 14, 2025		RX	Yes	Yes	12,551,483		Y

International Family Members for US Patent 12,551,483

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	134626
Taiwan	202541806
World Intellectual Property Organization (WIPO)	2025122952