United States Patent 9,867,799: Claim Scope, Givinostat Exclusivity, and DMD Patent Landscape

U.S. Patent No. 9,867,799 protects the use of givinostat, particularly givinostat hydrochloride, together with an anti-inflammatory agent for treating muscular dystrophy. The strongest commercial claim is directed to daily oral treatment of Duchenne muscular dystrophy in children using givinostat at 1-10 mg/kg/day with a corticosteroid. The patent does not broadly cover givinostat monotherapy, every givinostat formulation, or every use of givinostat.

Givinostat is marketed in the United States as Duvyzat by Italfarmaco. The FDA approved Duvyzat in March 2024 for patients age six years and older with Duchenne muscular dystrophy (FDA, 2024a). The patent’s nominal term extends into November 2034, subject to any patent-term adjustment, terminal disclaimer, or other recorded modification.

What drug and treatment does U.S. Patent 9,867,799 cover?

The claimed active ingredient is givinostat, identified in the claims by its chemical name:

diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphthalen-2-yl-methyl]-ammonium chloride

The claims also cover pharmaceutically acceptable salts and solvates. The compound is an orally active histone deacetylase inhibitor. Duvyzat contains givinostat hydrochloride.

The independent claim requires all of the following:

Required element	Scope
Patient	A patient in need of treatment
Disease	Muscular dystrophy
First active ingredient	Givinostat or a covered salt or solvate
Second active ingredient	One additional anti-inflammatory agent
Treatment activity	Administration to treat the patient

The claim is therefore a combination-treatment claim. Administration of givinostat alone does not satisfy claim 1 as written.

How do claims 1 through 16 divide the patent scope?

Claim 1: combination treatment

Claim 1 covers treating muscular dystrophy by administering givinostat together with one additional anti-inflammatory agent.

The phrase “active ingredients consisting of” is significant. It is narrower than an open-ended formulation or treatment claim and can be read to require the claimed active-ingredient combination to consist of givinostat and one additional anti-inflammatory agent. Excipients and other nonactive formulation components are not excluded because claim 10 expressly contemplates physiologically acceptable excipients.

Potential claim-construction disputes include:

Whether “one additional anti-inflammatory agent” permits more than one additional anti-inflammatory agent.
Whether an agent must be administered as a pharmacologically active treatment rather than being present incidentally.
Whether a corticosteroid used for standard DMD care qualifies even if prescribed primarily for disease management rather than as a separate anti-inflammatory indication.
Whether the claim requires a demonstrated synergistic or additive effect. The claim text supplied does not expressly require either result.

Claims 2 and 3: corticosteroid combinations

Claim 2 limits the additional anti-inflammatory agent to a steroid. Claim 3 provides a closed list:

Prednisolone
Prednisone
Deflazacort
Hydrocortisone
Methylprednisolone
Dexamethasone
Betamethasone
Triamcinolone
Beclometasone
Fludrocortisone acetate
Deoxycorticosterone acetate

The commercially important combinations are likely givinostat with prednisolone, prednisone, or deflazacort. These are established corticosteroid treatments for DMD and are more relevant than the mineralocorticoid compounds also listed in claim 3.

A competing product using givinostat with a steroid not listed in claim 3 could avoid claim 3 while remaining exposed to claim 2, provided the compound qualifies as a steroid and all claim 1 elements are met.

Claim 4: timing of administration

Claim 4 covers simultaneous, separate, or sequential administration. This substantially broadens the practical treatment arrangements covered by the patent.

The claim does not require:

A single dosage form containing both active ingredients.
Administration at the same clinical visit.
A fixed time interval between givinostat and the anti-inflammatory agent.
A particular order of administration, except that sequential administration must occur as part of the claimed treatment.

A combination product is not necessary. Separate prescriptions and separate dosage forms can fall within the literal scope if the treatment regimen satisfies the other limitations.

Claim 5: Duchenne muscular dystrophy

Claim 5 narrows the disease to Duchenne muscular dystrophy. This is the most commercially important dependent claim because Duvyzat is approved for DMD, not for all muscular dystrophy subtypes.

The claim does not appear limited by:

DMD mutation or exon status.
Ambulatory status.
Baseline corticosteroid use.
Age, except where claim 8 is invoked.
Disease stage.
Prior treatment with exon-skipping drugs or other DMD therapies.

Claims 6 through 9: frequency, dose, and pediatric use

Claim 6 requires daily administration.

Claim 7 specifies givinostat at 0.5-15 mg/kg/day. The dose limitation applies to givinostat, not to the additional anti-inflammatory agent.

Claim 8 requires that the patient be a child.

Claim 9 narrows the dose for pediatric patients to 1-10 mg/kg/day. A regimen involving a child with DMD, daily givinostat, and a corticosteroid at a givinostat dose within this range would implicate the core commercial combination of claims 1, 2, 5, 6, 8, and 9.

The dose claims create both enforcement value and design-around opportunities. A regimen outside the recited range may avoid claims 7 or 9 but would remain exposed to broader claims 1, 2, 5, or 6 if those limitations are otherwise satisfied.

Claims 10 through 14: formulation and route

Claim 10 covers givinostat administered in a pharmaceutical composition with at least one physiologically acceptable excipient.

Claim 11 covers:

Oral administration
Sublingual administration
Rectal administration
Intravascular administration
Intravenous administration
Subcutaneous administration

Claim 12 divides the composition into solid and liquid forms.

Claim 13 covers solid forms including:

Powder
Tablet
Granulate
Aggregate
Compressed pill
Coated pill
Hard gelatin capsule
Gelatin capsule

Claim 14 covers suspensions and syrups.

These claims are not limited to the Duvyzat commercial dosage form. They cover multiple dosage forms and routes, although infringement still requires the underlying combination treatment of claim 1. A givinostat tablet used as monotherapy would not satisfy claim 1 merely because it falls within a listed dosage form.

Claims 15 and 16: solid-state protection

Claim 15 covers the monohydrate form of givinostat hydrochloride.

Claim 16 covers givinostat hydrochloride in a crystal form. The supplied claim language does not identify a particular polymorph, crystal habit, unit cell, diffraction pattern, or analytical parameter.

The solid-state claims could create manufacturing and formulation risk if a generic or licensee uses the same monohydrate or crystal form. Their practical strength depends on the patent specification, written-description support, enablement, prosecution history, and the precise identity of the commercial material.

What is the strongest commercial claim combination?

The most commercially relevant claim set is:

Givinostat hydrochloride.
One additional corticosteroid.
Duchenne muscular dystrophy.
Daily administration.
Pediatric patient.
Givinostat at 1-10 mg/kg/day.
Administration in a pharmaceutical composition.
Oral liquid or solid dosage form.
Monohydrate or crystalline givinostat hydrochloride, where applicable.

A Duvyzat regimen used in a child with DMD who is also receiving prednisolone, prednisone, or deflazacort could satisfy this layered claim structure. The patent does not require the branded Duvyzat product, so an ANDA applicant could face method-of-use exposure even if it develops a different formulation or uses a different manufacturer.

When does U.S. Patent 9,867,799 lose exclusivity?

The patent’s nominal expiration is approximately November 2034 based on the U.S. patent-term framework and the public filing chronology associated with the patent. The operative date should be determined from the USPTO patent record, including any patent-term adjustment and terminal disclaimer information.

Milestone	Date or status
U.S. patent	9,867,799
Patent type	Method-of-treatment patent
Primary compound	Givinostat hydrochloride
Commercial product	Duvyzat
FDA approval	March 21, 2024
Nominal patent expiry	Approximately November 2034
Pediatric exclusivity	FDA pediatric exclusivity may extend relevant listed exclusivity by six months if applicable
PTE relevance	No automatic extension should be assumed without an issued USPTO or FDA determination

The patent term is separate from FDA regulatory exclusivity. FDA approval of Duvyzat does not itself establish that Patent No. 9,867,799 is listed in the Orange Book, nor does Orange Book listing alone determine whether every claim is enforceable against a particular product.

What is the FDA and Orange Book status of Duvyzat?

The FDA approved Duvyzat for patients six years of age and older with DMD. Duvyzat is an oral suspension containing givinostat and is administered according to body weight and platelet-monitoring requirements described in the prescribing information (FDA, 2024a).

The approval is relevant to Patent No. 9,867,799 for three reasons:

The approved population includes pediatric DMD patients.
Standard DMD treatment commonly involves corticosteroids.
The product’s oral liquid presentation falls within the dosage-form categories recited by claims 10 through 14.

Orange Book analysis requires separating three issues:

Whether Patent No. 9,867,799 is listed for Duvyzat.
What FDA use code is assigned to the listing.
Whether an ANDA applicant’s proposed labeling overlaps the listed use.

A method patent listed with a DMD use code could trigger a Paragraph IV certification for an ANDA seeking approval before patent expiration. If the ANDA label excludes the patented combination or disease use, a section viii statement may be available, but that route is more difficult where DMD is the applicant’s only proposed indication and routine corticosteroid coadministration is reflected in clinical practice or labeling.

What Paragraph IV challenges and generic-entry risks exist?

A generic applicant seeking approval before the patent’s expiration could pursue several strategies.

Paragraph IV certification

The applicant could assert that the patent is invalid, unenforceable, or not infringed. Potential arguments may include:

Lack of novelty or obviousness based on prior givinostat use, corticosteroid combination therapy, or DMD treatment disclosures.
Written-description or enablement challenges to the broad muscular dystrophy and anti-inflammatory-agent language.
Indefiniteness arguments concerning “one additional anti-inflammatory agent.”
Noninfringement based on a nonsteroidal agent, a different dosing schedule, or treatment outside the recited dose range.
Noninfringement based on monotherapy.
Noninfringement based on a formulation or solid form outside claims 10 through 16.

A Paragraph IV notice could trigger Hatch-Waxman litigation and a 30-month stay of FDA approval if the patent is timely listed and the NDA holder or patent owner files suit within the statutory period (21 U.S.C. § 355).

Section viii carve-out

A label carve-out could remove DMD combination treatment or another patented use. The commercial value of that strategy would depend on whether the remaining label has a viable noninfringing use. For Duvyzat, a narrow carve-out may be difficult because the product’s principal approved use is DMD treatment.

Formulation or manufacturing alternative

A generic applicant could attempt to avoid claims 10 through 16 by using:

A different salt.
An anhydrous form.
A nonclaimed polymorph.
A different excipient system.
A different dosage form.
A different route of administration.

These approaches would not necessarily avoid claim 1, which is directed to treatment with givinostat and an additional anti-inflammatory agent.

How strong is the patent estate for givinostat?

Patent strength is mixed by claim category.

Claim category	Commercial strength	Main vulnerability
Givinostat plus anti-inflammatory agent	High if approved labeling and practice require corticosteroids	Obviousness and claim-construction challenges
Givinostat plus steroid	High for standard DMD regimens	Potential design-around using nonsteroidal agents
DMD-specific treatment	High against Duvyzat-related use	Prior-art and written-description scrutiny
Pediatric daily dosing	Moderate to high	Dose or schedule design-arounds
Oral composition	Moderate	Broad formulation and enablement challenges
Monohydrate	Potentially high if commercial material uses it	Solid-state characterization and noninfringement
Generic crystal form	Depends heavily on specification and prosecution history	Claim breadth may exceed disclosed crystal data

The patent is stronger as a use patent tied to the approved DMD population than as a broad platform patent covering all givinostat products. A competitor that sells givinostat for an unrelated indication or as monotherapy may avoid the principal method claims.

What competing DMD drugs affect the landscape?

Duvyzat competes with corticosteroids, mutation-specific therapies, and other disease-modifying products.

Product	Active ingredient	Sponsor	DMD role
Duvyzat	Givinostat	Italfarmaco	Nonsteroidal oral treatment for DMD patients age six and older
Emflaza	Deflazacort	Santhera and partners	Corticosteroid
Prednisone products	Prednisone	Multiple manufacturers	Standard corticosteroid treatment
Exondys 51	Eteplirsen	Sarepta	Exon 51 skipping
Vyondys 53	Golodirsen	Sarepta	Exon 53 skipping
Viltepso	Viltolarsen	NS Pharma	Exon 53 skipping
Amondys 45	Casimersen	Sarepta	Exon 45 skipping
Agamree	Vamorolone	Santhera	Corticosteroid receptor-modifying treatment

These products generally do not create direct patent overlap with the claims of Patent No. 9,867,799 unless givinostat is used in combination with them or their labeling induces the patented givinostat-plus-anti-inflammatory regimen.

Are biosimilar risks relevant to Patent 9,867,799?

Biosimilar risk is not the principal challenge. Givinostat is a small molecule, not a biologic, and Duvyzat is regulated through the small-molecule NDA pathway. The relevant competitive pathway is an ANDA or, for a different clinical product, a 505(b)(2) application.

The main barriers are therefore:

Patent claims covering combination treatment.
Potential Orange Book listings.
Solid-state and formulation patents.
FDA labeling restrictions.
Clinical and manufacturing requirements for givinostat.
Control of the active pharmaceutical ingredient and process know-how.

What litigation and settlement issues matter?

A complete litigation assessment requires review of district-court dockets, Federal Circuit decisions, USPTO prosecution records, Orange Book listings, and any confidential or public settlement filings. The claims alone do not establish whether an ANDA Paragraph IV notice has been served, whether litigation has been filed, or whether a settlement exists.

The commercially material litigation questions are:

Is Patent No. 9,867,799 listed against Duvyzat?
What use code describes the listed patent?
Has an ANDA applicant filed a Paragraph IV certification?
Has Italfarmaco sued within the statutory period?
Does any settlement permit an authorized generic or licensed early launch?
Are claims 15 and 16 supported by the commercial monohydrate or crystal form?
Does the FDA-approved label instruct or encourage coadministration with a corticosteroid?

Key Takeaways

Patent No. 9,867,799 is primarily a combination-treatment patent for givinostat plus an anti-inflammatory agent.
The commercially important embodiment is daily givinostat treatment of pediatric DMD patients receiving corticosteroids.
Claim 1 does not cover givinostat monotherapy.
Claim 4 reaches simultaneous, separate, and sequential administration.
Claims 7 and 9 create dose-specific protection at 0.5-15 mg/kg/day and 1-10 mg/kg/day for children.
Claims 10 through 14 cover broad pharmaceutical compositions, routes, and dosage forms.
Claims 15 and 16 may provide additional protection for givinostat hydrochloride monohydrate and crystalline material.
Duvyzat’s FDA approval creates direct commercial relevance for the pediatric DMD claims.
Generic entry would likely involve Paragraph IV, a label carve-out, a formulation design-around, or a combination of those strategies.
Biosimilar competition is not the relevant pathway because givinostat is a small-molecule drug.
The nominal patent expiry is approximately November 2034, subject to the official USPTO term calculation and any applicable exclusivity extension.

FAQs

Does Patent 9,867,799 cover Duvyzat used without a steroid?

Generally, no. The independent claim requires givinostat and one additional anti-inflammatory agent. Duvyzat monotherapy would not satisfy that combination limitation, although other patents or regulatory rights could apply.

Can a generic avoid the patent by using prednisone instead of prednisolone?

No. Both prednisone and prednisolone are expressly listed in claim 3. Substituting between those two agents would not avoid the corticosteroid limitation.

Does separate prescribing of givinostat and a corticosteroid avoid infringement?

Not necessarily. Claim 4 expressly covers simultaneous, separate, or sequential administration. Separate products can still fall within the claim if they are administered as part of the claimed treatment regimen.

Does a nonoral givinostat product avoid the patent?

It may avoid claims limited by oral administration or particular dosage forms, but the patent claims supplied include broad treatment claims that are not limited to oral administration. The full claim set and prosecution history would control.

Can an ANDA applicant launch before 2034 with a skinny label?

Possibly, but the strategy depends on the Orange Book listing, FDA use code, proposed labeling, and whether the remaining approved uses are commercially viable without inducing the patented DMD combination treatment.

References

Food and Drug Administration. (2024a). Duvyzat (givinostat) oral suspension prescribing information. U.S. Department of Health and Human Services.
Food and Drug Administration. (2024b). FDA approves first nonsteroidal treatment for patients with Duchenne muscular dystrophy. U.S. Department of Health and Human Services.
United States Patent and Trademark Office. (2018). U.S. Patent No. 9,867,799, treatment of muscular dystrophy using givinostat and an anti-inflammatory agent.
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355.
U.S. Food and Drug Administration. (2024c). Approved drug products with therapeutic equivalence evaluations. Center for Drug Evaluation and Research.

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	9,867,799	⤷ Start Trial				A METHOD FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) USING GIVINOSTAT	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	089839	⤷ Start Trial
Australia	2012368818	⤷ Start Trial
Brazil	112014018975	⤷ Start Trial
Canada	2857082	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,867,799

Which drugs does patent 9,867,799 protect, and when does it expire?

Summary for Patent: 9,867,799