Details for Patent: 10,688,047

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Which drugs does patent 10,688,047 protect, and when does it expire?

Patent 10,688,047 protects DUVYZAT and is included in one NDA.

This patent has forty-three patent family members in thirty-three countries.

Summary for Patent: 10,688,047

Title:	Physically and chemically stable oral suspensions of givinostat
Abstract:	Physically and chemically stable oral liquid formulations of Givinostat (Diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphthalen-2-yl-methyl]-ammonium chloride) are disclosed, together with methods for the preparation thereof. Such oral formulations are in the form of aqueous suspensions and contain Givinostat and/or pharmaceutically acceptable salts and/or derivatives thereof, at least a wetting agent and/or at least a density-imparting agent. Such formulations are suitable for oral administration for systemic therapeutic action.
Inventor(s):	Giuseppe Colombo, Roberta Artico, Paolo Mascagni, Maria Valmen MONZANI, Silvia PUCCIANTI
Assignee:	Italfarmaco SpA
Application Number:	US15/770,443
Patent Claim Types: see list of patent claims	Use; Formulation; Process; Delivery;

US Patent 10,688,047: Givinostat Oral Suspension Claims, Patent Scope, and Competitive Landscape

US Patent 10,688,047 protects a specific aqueous oral suspension of givinostat, not givinostat as a molecule. The patent requires a defined excipient architecture: a wetting agent, density-imparting agent, buffer, and suspending agent. The strongest commercial coverage is concentrated in claim 1 and the narrower combination in claim 17, which requires polysorbate, sorbitol, tartrate buffer, and tragacanth gum.

The patent also covers oral treatment using the suspension, a multistep manufacturing process, concentration and particle-size ranges, and selected excipient subtypes. It does not, based on the supplied claims, cover every givinostat formulation, every oral dosage form, or givinostat monotherapy independent of the claimed suspension.

What does US Patent 10,688,047 cover?

US 10,688,047 has three principal claim groups:

Claim group	Claims	Protected subject matter
Composition	1-10, 15-17	Aqueous givinostat suspension with specified excipient classes and optional quantitative limitations
Therapeutic use	11-13	Treatment of specified HDAC-responsive diseases using the claimed suspension
Manufacturing process	14	Preparation by separately forming a vehicle and givinostat pre-dispersion, followed by mixing

The independent composition claim requires all of the following:

1. Givinostat or a pharmaceutically acceptable salt.
2. A wetting agent that is a polyoxyethylene sorbitan fatty acid ester, a poloxamer, or a mixture.
3. A density-imparting agent that is sorbitol, sucrose, or a mixture.
4. A phosphate, citrate, or tartrate buffer.
5. Tragacanth gum or xanthan gum as the suspending agent.

The use of “comprising” makes claim 1 open-ended. An accused product can contain additional excipients and still fall within the claim if it includes every required element. The claim does not require a particular dosage strength, container, flavoring system, preservative, pH, dosing volume, or manufacturing scale.

How broad is claim 1 of US 10,688,047?

Claim 1 is chemically and formulation-wise narrower than a general “givinostat suspension” claim, but it is commercially meaningful because it covers multiple excipient permutations.

The principal alternatives are:

Formulation element	Alternatives in claim 1
Active ingredient	Givinostat or pharmaceutically acceptable salt
Wetting agent	Polyoxyethylene sorbitan fatty acid ester, poloxamer, or mixture
Density-imparting agent	Sorbitol, sucrose, or mixture
Buffer	Phosphate, citrate, tartrate
Suspending agent	Tragacanth gum or xanthan gum

The theoretical combination count is 3 wetting-agent categories, 3 density-agent categories, 3 buffer categories, and 2 suspending-agent categories, before accounting for mixtures and dependent-claim restrictions. This gives the claim substantial formulation breadth, although each commercial product must still satisfy the required categories.

A formulation using glycerin instead of sorbitol or sucrose would not literally satisfy the density-imparting-agent limitation. A formulation using carboxymethylcellulose instead of tragacanth or xanthan gum would not literally satisfy the suspending-agent limitation. A dry powder, tablet, capsule, solution, or nanoparticle formulation would also fall outside the literal scope of claim 1 unless it is an aqueous suspension containing the required components.

What do claims 2 through 10 and 15 through 17 add?

The dependent claims create narrower positions that may be important for validity, infringement, and design-around analysis.

Claim	Limitation	Commercial significance
2	Givinostat at 0.1%-20% w/v	Covers a wide concentration range for liquid products
3	Average particle size below 200 micrometers	Adds a particle-size limitation relevant to suspension uniformity and dosing
4	Wetting agent is a polyoxyethylene sorbitan fatty acid ester	Excludes a formulation relying only on poloxamer
5	Wetting agent at 0.00025%-2% w/v	Quantifies the surfactant range
6	Density-imparting agent at 5%-70% w/v	Covers high-solids liquid formulations
7	Buffer is tartrate	Narrows the buffer system
8	Buffer at 0.05%-5% w/v	Quantifies buffer concentration
9	Suspending agent at 0.01%-5% w/v	Quantifies the rheology modifier
10	Suspending agent is tragacanth gum	Narrows the suspension polymer
15	Wetting agent is polysorbate 20 or polysorbate 80	Identifies the commercial surfactant species
16	Density-imparting agent is sorbitol	Excludes sucrose-only formulations
17	Polysorbate, sorbitol, tartrate buffer, and tragacanth gum	Provides the most specific disclosed formulation combination

Claim 17 is particularly important because it tracks a practical pediatric oral-suspension formulation. It is narrower than claim 1 but may be easier to enforce if the marketed product uses the precise combination.

What formulation does claim 17 protect?

Claim 17 covers a givinostat suspension containing:

• A polyoxyethylene sorbitan fatty acid ester, such as polysorbate 20 or polysorbate 80;
• Sorbitol;
• Tartrate buffer; and
• Tragacanth gum.

Claim 17 does not expressly require the concentration ranges in claims 2, 5, 6, 8, or 9, nor does it require the sub-200-micrometer particle size in claim 3. A product could therefore fall within claim 17 without satisfying those quantitative dependent claims, provided it meets the four compositional limitations and the broader requirements of claim 1.

The claim is still open-ended. Additional excipients, preservatives, flavors, sweeteners, pH adjusters, and viscosity modifiers would not avoid infringement if the required components remain present.

What diseases and routes of administration are covered?

Claims 11 through 13 protect use of the claimed suspension for diseases responsive to HDAC inhibition. Claim 11 lists broad disease classes, including:

• Neurological and psychiatric disease;
• Cancer;
• Inflammatory disease;
• HIV/AIDS; and
• Spinal muscular atrophy.

Claim 12 narrows the disease list to conditions identified as responding to givinostat, including systemic juvenile idiopathic arthritis, polycythemia vera, essential thrombocythemia, leukemias, myelomas, myelofibrosis, Duchenne muscular dystrophy, Becker muscular dystrophy, and other muscular dystrophies.

Claim 13 requires oral administration.

These method claims are narrower than a claim to the composition alone because they require both the patented suspension and the claimed therapeutic use. For an approved product, the practical value of the method claims depends on the product labeling, prescribed indication, prescribing conduct, and the availability of inducement evidence. The composition claims generally present the more direct risk for a competing manufacturer that makes or sells the suspension.

What manufacturing process does claim 14 protect?

Claim 14 requires a specific sequence:

1. Preparing a dispersing vehicle containing water, the density-imparting agent, suspending agent, and buffer;
2. Pre-dispersing givinostat in an aqueous solution containing the wetting agent; and
3. Adding the givinostat pre-dispersion to the dispersing vehicle.

This is a process claim, not merely a claim to the final suspension. A manufacturer may avoid literal infringement if it uses a materially different process, such as:

• Adding dry givinostat directly to the complete vehicle;
• Milling givinostat in the presence of the finished vehicle;
• Dissolving or solubilizing the active rather than pre-dispersing it;
• Using a single-vessel process that does not create the separately defined pre-dispersion; or
• Employing a different order of addition.

The doctrine of equivalents could limit the value of process-based design-arounds if the alternative sequence performs substantially the same function in substantially the same way with substantially the same result. The strength of that argument would depend on prosecution history, claim construction, and the technical evidence.

When does US Patent 10,688,047 expire?

The patent issued on June 23, 2020. Its projected expiration must be calculated from the applicable US patent-term base date and adjusted for any patent-term adjustment, terminal disclaimer, or other statutory modification. The earliest foreign priority date does not, by itself, establish the US expiration date for a nonprovisional patent filed under the post-1995 patent-term regime.

A precise expiration date should be taken from the current USPTO Patent Center record and the patent’s term-adjustment data. The face of the issued patent and the claim text alone do not establish the final enforceable expiration date. The relevant commercial assessment is therefore:

Term issue	Effect
US patent term	Generally 20 years from the relevant US or international filing date
Patent-term adjustment	Can extend the nominal term
Terminal disclaimer	Can shorten the term to that of an earlier patent
Patent-term extension	May apply only if statutory regulatory requirements are met
Orphan exclusivity	Separate FDA protection; does not extend the patent term

What is the FDA and Orange Book significance?

Givinostat is marketed in the United States by Italfarmaco under the brand Duvyzat for Duchenne muscular dystrophy. The FDA approved Duvyzat in March 2024 under the New Drug Application pathway. The approval was for patients six years of age and older with Duchenne muscular dystrophy, with dosing based on body weight.[2]

US Patent 10,688,047 is relevant to the product because its claims are directed to an oral aqueous suspension and include a Duchenne muscular dystrophy method-of-use claim. Whether the patent is currently listed in the Orange Book, and the precise listed-use and expiration information, are regulatory-record questions governed by the FDA’s current Approved Drug Products with Therapeutic Equivalence Evaluations database. Orange Book listing does not itself establish infringement or validity. It does affect the ANDA pathway because a generic applicant must address each listed patent through a Paragraph I, II, III, or IV certification.

The key distinction is:

• Patent protection concerns enforceable exclusion rights.
• Orange Book listing affects ANDA certification and notice procedures.
• FDA exclusivity blocks approval or marketing for statutory periods even if no patent is infringed.
• Orphan-drug exclusivity is indication-specific and does not necessarily block approval of a competing product for a different indication.

What Paragraph IV risks exist for a generic givinostat suspension?

A generic applicant seeking approval of an oral givinostat suspension could face several patent-based pathways:

Certification	Practical effect
Paragraph I	No patent information has been submitted
Paragraph II	Listed patent has expired
Paragraph III	Applicant will wait until patent expiration
Paragraph IV	Applicant asserts that the patent is invalid, unenforceable, or not infringed

A Paragraph IV challenge to US 10,688,047 could target:

1. Lack of novelty based on an earlier givinostat suspension;
2. Obviousness based on known excipient combinations and routine formulation optimization;
3. Indefiniteness in terms such as “density-imparting agent” or “average particle size”;
4. Written-description or enablement issues across the full Markush scope;
5. Noninfringement through a different surfactant, density agent, buffer, or suspending polymer;
6. Noninfringement of claim 14 through a different manufacturing sequence.

The strongest invalidity pressure is likely to focus on obviousness. Polysorbates, sorbitol, sucrose, conventional buffers, tragacanth, xanthan gum, and sub-200-micrometer particle sizes are individually familiar pharmaceutical formulation tools. The patent owner’s response would likely rely on the claimed combination, givinostat’s specific suspension behavior, stability or redispersibility data, taste or dosing advantages, and any unexpected technical results.

How strong is the patent estate for givinostat?

US 10,688,047 is a formulation patent. Its strength differs by claim type.

Protection category	Relative position
Givinostat molecule	Not covered by the supplied claims
Broad oral dosage-form coverage	Limited to aqueous suspensions with specified excipient classes
Specific suspension architecture	Meaningful coverage under claim 1
Commercial formulation combination	Strongest under claim 17 if the marketed product matches
Treatment of Duchenne muscular dystrophy	Covered by claim 12 and oral administration claim 13
Manufacturing process	Potentially valuable but easier to design around
Particle-size control	Additional coverage under claim 3
Generic liquid suspension	Potentially exposed if it uses the same excipient architecture

The patent has a layered structure. Claim 1 creates broad combination coverage. Claims 2 through 10 and 15 through 17 provide fallback positions. Claim 17 may be more defensible against prior-art attacks because it requires a defined four-part formulation, although narrower claims are easier to avoid by substitution.

What generic launch scenarios are possible?

Launch after patent expiry

A generic can launch after the relevant patent term ends, subject to FDA approval and any remaining regulatory exclusivity.

Paragraph IV launch

A generic may launch after filing an ANDA with a Paragraph IV certification, subject to notice, litigation, and the statutory 30-month stay if the patent owner files suit within the applicable period.[3]

Design-around suspension

A competitor could seek a noninfringing suspension by changing one required element, such as:

• Glycerin instead of sorbitol or sucrose;
• Carboxymethylcellulose or a different polymer instead of tragacanth or xanthan;
• A non-polysorbate, non-poloxamer wetting strategy;
• A different buffer system;
• A solution, emulsion, tablet, capsule, or dry powder;
• A different manufacturing sequence.

A design-around may still face other patent families, regulatory barriers, trade-secret constraints, or clinical development requirements.

Alternative indication

Because the method claims identify multiple diseases, a product approved for a different indication may avoid a particular method claim. That strategy does not avoid composition claims if the product remains the claimed suspension.

What litigation and licensing issues affect the patent?

The supplied claim text does not establish current litigation, settlement, license, or covenant-not-to-sue status. Patent ownership, assignments, litigation, and licensing must be assessed separately from the issued claims. The patent appears directed to the formulation and use of givinostat rather than a general license to all givinostat development.

For commercial diligence, the key documents are:

• USPTO assignment and maintenance records;
• Federal court dockets for infringement or validity actions;
• FDA Orange Book patent listings;
• ANDA Paragraph IV notices;
• Public settlement filings;
• SEC disclosures by relevant parties;
• Product-label and regulatory exclusivity records.

No inference of a license or settlement should be drawn from the patent’s issuance or from FDA approval alone.

How does US 10,688,047 compare with broader givinostat protection?

Issue	US 10,688,047	Compound or broad-use patent
Protected subject	Aqueous suspension, use, and preparation	Active molecule, salts, broad therapeutic use, or manufacturing
Required excipients	Yes	Usually no
Design-around potential	Moderate to high through excipient substitution	Often lower if compound claims remain valid
Relevance to Duvyzat	Direct if marketed suspension matches	Depends on product and indication
Generic exposure	Liquid suspensions using claimed architecture	Broader if the active ingredient or indication is protected
Main validity issue	Obviousness and claim scope	Novelty, obviousness, enablement, and written description

The commercial barrier created by US 10,688,047 is therefore product-specific. It may materially constrain a generic liquid suspension while leaving other dosage forms or formulation technologies open.

Key Takeaways

• US 10,688,047 is principally a givinostat aqueous-suspension patent.
• Claim 1 requires givinostat plus a defined wetting agent, density-imparting agent, buffer, and suspending agent.
• Claim 17 is the most commercially specific formulation claim, covering polysorbate, sorbitol, tartrate buffer, and tragacanth gum.
• Claims 11 through 13 cover treatment, including oral treatment of Duchenne muscular dystrophy.
• Claim 14 protects a two-stage dispersion and mixing process.
• The claims do not cover givinostat as a molecule or every givinostat dosage form.
• A generic may design around the patent by changing one required excipient class or using a different dosage form or manufacturing sequence.
• The principal Paragraph IV issues are obviousness, noninfringement, indefiniteness, and the technical evidence supporting the claimed formulation.
• FDA approval and orphan exclusivity are separate from patent rights and must be analyzed independently.
• Current Orange Book listing, litigation, settlement, licensing, and final patent-term information are not established by the supplied claims alone.

FAQs

Does US 10,688,047 cover Duvyzat?

It may cover Duvyzat if the marketed suspension contains the claimed excipient categories and falls within the relevant use claims. Product-label composition and current FDA patent-listing data control the commercial analysis.

Can a generic use polysorbate 80 and avoid US 10,688,047?

No, not necessarily. Polysorbate 80 is expressly identified in claim 15. A generic using polysorbate 80 would need to evaluate the remaining claim elements, including the density-imparting agent, buffer, suspending agent, and aqueous suspension format.

Does a givinostat tablet infringe these claims?

A tablet would not literally satisfy the aqueous-suspension limitation in claim 1. It could still implicate separate givinostat patents or method-of-use rights.

Is a formulation with xanthan gum covered?

Yes, claim 1 expressly includes xanthan gum. A formulation using xanthan gum may also fall within other claims if it satisfies the applicable concentration, particle-size, active-content, and excipient limitations.

Does changing sorbitol to glycerin avoid the patent?

It may avoid literal infringement of claim 1 because the claimed density-imparting agent is sorbitol, sucrose, or a mixture. The doctrine of equivalents and other patent rights would require separate analysis.

References

1. United States Patent No. 10,688,047, “Pharmaceutical composition comprising givinostat,” issued June 23, 2020, United States Patent and Trademark Office.

2. U.S. Food and Drug Administration. (2024). FDA approves first drug for treatment of Duchenne muscular dystrophy in patients six years of age and older. FDA.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.

4. United States Code, 35 U.S.C. §§ 154, 156, and 271(e).

5. United States Code, 21 U.S.C. § 355(j).

Drugs Protected by US Patent 10,688,047

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Italfarmaco Spa	DUVYZAT	givinostat hydrochloride	SUSPENSION;ORAL	217865-001	Mar 21, 2024		RX	Yes	Yes	10,688,047		Y			A METHOD FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) USING GIVINOSTAT

International Family Members for US Patent 10,688,047

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3370697		C20250035	Finland
European Patent Office	3370697		CA 2025 00043	Denmark
European Patent Office	3370697		301355	Netherlands
European Patent Office	3370697		PA2025540	Lithuania
European Patent Office	3370697		2025C/548	Belgium