Details for Patent: 11,744,835

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Which drugs does patent 11,744,835 protect, and when does it expire?

Patent 11,744,835 protects YUTREPIA and is included in one NDA.

This patent has twelve patent family members in six countries.

Summary for Patent: 11,744,835

Title:	Dry powder treprostinil for the treatment of pulmonary hypertension
Abstract:	A dry powder inhalation treatment for pulmonary arterial hypertension includes a dose of dry particles comprising greater than 25 micrograms of treprostinil enclosed in a capsule. The dry particles can include treprostinil, a wetting agent, a hydrophobicity modifying agent, a pH modifying agent and a buffer. A method of treating a patient having pulmonary arterial hypertension includes providing a patient a dry powder inhaler, providing the patient at least one capsule for use in the dry powder inhaler, the capsule including at least 25 micrograms of treprostinil.
Inventor(s):	Robert Frank Roscigno, Brian T. Farrer, Jacob J. Sprague, Benjamin Maynor
Assignee:	Liquidia Technologies Inc
Application Number:	US17/390,476
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Delivery; Dosage form;

United States Patent 11,744,835: Treprostinil Dry-Powder Inhalation Patent Scope and Landscape

US Patent 11,744,835 protects a unit-dose dry-powder treprostinil treatment for pulmonary arterial hypertension, with defined dose ranges, particle engineering, excipient composition, capsule or dosage-unit presentation, moisture limits, and aerodynamic size. Its commercial relevance is concentrated in dry-powder inhaled treprostinil products, particularly Tyvaso DPI and technically similar products.

The strongest claim combination is the intersection of: treprostinil dry powder, formation from a solution containing a pH-modifying agent and bulking agent, DPI-compatible dosage units, a total dose of 100 to 350 micrograms, and particle or formulation characteristics such as 1 to 5 micrometer MMAD, low residual water, and the specified excipient matrix.

What does US Patent 11,744,835 protect?

The patent protects a pharmaceutical product configuration rather than a broad treprostinil treatment concept. Claim 1 requires all of the following:

Required limitation	Scope
Active ingredient	Treprostinil or a pharmaceutically acceptable salt
Dosage form	Dry powder particles
Matrix	An excipient matrix
Manufacturing origin	Particles formed from a solution
Required solution components	A pH-modifying agent and a bulking agent
Delivery system	One or more dosage units configured for a dry-powder inhaler
Dose	Total treprostinil amount of 100 to 350 micrograms
Therapeutic purpose	Treatment of pulmonary arterial hypertension

The claim is narrower than a claim covering any inhaled treprostinil formulation. A competing product could avoid literal infringement by omitting or changing one required limitation, such as the manufacturing solution, the specified dose architecture, or the DPI dosage-unit configuration.

The claim language also creates two separate technical inquiries in an infringement analysis:

1. Whether the accused particles contain the required composition and physical properties.
2. Whether the particles were formed from a solution containing the required pH-modifying and bulking agents.

The second inquiry may depend on how a court construes "formed from a solution." If treated as a process limitation, manufacturing records, batch records, formulation protocols, and development history may be material. If treated as a structural limitation, the patent owner would need to connect the manufacturing step to identifiable characteristics of the finished particles.

How broad is independent claim 1?

Claim 1 has moderate breadth in chemical composition but substantial narrowing through dosage form and dose limitations.

Chemical scope

The active ingredient may be treprostinil itself or a pharmaceutically acceptable salt. The claim does not limit the active ingredient to a specific salt, although the salt must retain pharmaceutical acceptability and fall within the claim's treprostinil scope.

The claim does not require the excipient matrix to contain the exact ingredients later recited in claim 12. A formulation can therefore fall within claim 1 without containing trehalose, L-leucine, polysorbate 80, sodium citrate, or sodium chloride, provided it has an excipient matrix and the particles were formed from a solution containing a pH-modifying agent and bulking agent.

Delivery-system scope

The claim covers one or more dosage units configured for insertion into a dry-powder inhaler. Claim 16 narrows this to capsules. Claim 15 separately covers packaging in a closeable container with a cap.

The patent therefore reaches more than the powder itself. It potentially covers a packaged dose presentation in which the powder is supplied in inhaler-compatible units.

Dose scope

Claim 1 requires a total predetermined treprostinil amount from 100 to 350 micrograms across one or more dosage units. This is a central commercial limitation.

A product containing 90 micrograms total would fall outside claim 1, subject to other claims or related patents. A product containing 400 micrograms total would also fall outside claim 1. The dose must be evaluated based on treprostinil active amount, not merely total powder weight.

What do dependent claims 2 through 8 cover?

Claims 2 through 8 narrow the dose and powder-loading alternatives.

Claim	Limitation
2	Each dosage unit contains 50 to 220 micrograms treprostinil
3	Each dosage unit contains 50 to 110 micrograms
4	Each dosage unit contains 100 to 220 micrograms
5	Each dosage unit contains 2.5 to 15 mg dry powder
6	Each dosage unit contains at least 15 mg dry powder
7	Particles contain about 0.53% treprostinil by weight
8	Particles contain about 1.06% treprostinil by weight

Claims 3 and 4 create a notable overlap issue. Claim 4 depends from claim 3, which limits each dosage unit to 50 to 110 micrograms, and then recites 100 to 220 micrograms. The effective intersection is approximately 100 to 110 micrograms per dosage unit.

The dose-loading claims are commercially important because dry-powder inhalers can use one or more capsules to deliver a target patient dose. A formulation may use a relatively low treprostinil concentration and a larger powder mass, or a higher concentration and a smaller powder mass.

The approximate 0.53% and 1.06% concentrations correspond to materially different powder-load requirements. For example, at 0.53% w/w, delivery of 100 micrograms of treprostinil requires approximately 18.9 mg of powder before accounting for device and emitted-dose losses. At 1.06% w/w, the same active amount requires approximately 9.4 mg of powder.

What particle and formulation characteristics are protected?

Claims 9 through 14 add physical and compositional limitations that target aerosol performance and product stability.

Aerodynamic particle size

Claims 9 and 10 require:

• MMAD of 1 to 5 micrometers under claim 9.
• MMAD of 3 micrometers or less under claim 10.

MMAD is a critical inhalation-performance parameter. It does not necessarily equal geometric particle diameter. It reflects aerodynamic behavior, including particle density and shape, and is ordinarily measured through cascade impaction or a comparable aerosol-characterization method.

A product with an MMAD above 5 micrometers would not satisfy claim 9. A product with an MMAD of 3 micrometers or less would satisfy the narrower size limitation if the remaining limitations are met.

Additional solution ingredients

Claim 11 adds one or more of:

• A wetting agent
• A hydrophobicity modifier
• A buffer

Claim 12 specifies the excipient matrix as comprising:

• Trehalose
• L-leucine
• Polysorbate 80
• Sodium citrate
• Sodium chloride

Claim 12 is substantially narrower than claim 1. A product containing all five listed excipients, together with the other claim limitations, presents a higher infringement risk than a product using a materially different matrix.

Moisture content

Claim 13 requires less than 5% water content. Claim 14 narrows this to less than 2%.

These limits are typically evaluated by Karl Fischer analysis or another validated moisture method. The relevant question is the water content of the finished dry powder particles, not necessarily the moisture level of the capsule shell or secondary packaging.

The moisture limitations can create manufacturing and quality-control exposure. A formulation may meet the chemical composition and dose requirements but avoid claims 13 and 14 if its residual water content is above the specified thresholds. That does not avoid claim 1 or other claims.

How do claims 15 through 21 affect infringement risk?

Claims 15 through 21 extend protection into packaging, capsule delivery, powder loading, particle-size control, and particle morphology.

Packaging

Claim 15 covers the dose packaged in a closeable container with a cap. The claim is relatively broad as a packaging limitation, but it remains dependent on claim 1. The packaging limitation alone does not create infringement unless the underlying treprostinil powder, solution-origin, dosage-unit, and dose requirements are also satisfied.

Capsules and breath count

Claims 16 and 17 cover capsules configured for use in a dry-powder inhaler, with the capsule contents deliverable over one to two breaths.

Claims 18 and 19 combine capsule presentation with approximate active concentrations:

• About 0.5% treprostinil by weight
• About 1% treprostinil by weight

Each capsule must contain 50 to 220 micrograms of treprostinil, and the dose must be configured for one to two breaths.

These claims are directed toward practical commercial use. They may be relevant to products that use puncturable capsules rather than blister strips, reservoirs, or preloaded proprietary cartridges.

Particle uniformity and predetermined size

Claim 20 requires particles formed with a predetermined size range. Claim 21 requires particles that are substantially uniform in shape.

These limitations may be difficult to enforce without a clear construction of "predetermined" and "substantially uniform." Particle-size distribution data, microscopy, laser diffraction, aerodynamic testing, and manufacturing specifications would likely be relevant.

What is the likely commercial relationship to Tyvaso DPI?

Tyvaso DPI is an FDA-approved dry-powder inhaled treprostinil product marketed by United Therapeutics for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. The FDA approved Tyvaso DPI in 2022 under NDA 214324. [1]

The claim set is technically aligned with a commercial product using:

• Treprostinil dry powder
• Unit-dose inhalation delivery
• A dry-powder inhaler
• Capsule or dosage-unit handling
• Low-microgram pulmonary dosing
• Engineered aerosol particles

A product-by-product comparison requires the approved product's formulation, capsule fill, manufacturing process, aerosol specifications, and current labeling. The supplied claim text alone does not establish which individual Tyvaso DPI components correspond to every limitation.

What is the Orange Book status of US Patent 11,744,835?

The Orange Book question must be analyzed separately from patent ownership and infringement.

An FDA-listed patent can be relevant to an abbreviated new drug application, but listing does not establish that every claim is valid, enforceable, or infringed. Conversely, a patent that is not listed may still create litigation risk under the Hatch-Waxman Act or ordinary patent law if its claims cover the proposed product.

For this patent, the critical Orange Book issues are:

Issue	Relevance
Listed drug	Whether the patent is associated with an approved treprostinil product
Patent type	Whether the listed claims cover drug substance, formulation, method of use, or delivery system
Expiration	Whether generic applicants must address the patent before launch
Certification	Whether an ANDA filer could submit a Paragraph IV certification
Regulatory timing	Whether the patent remains relevant after pediatric and regulatory exclusivities expire

The supplied claim text does not establish the patent's current Orange Book listing status, use code, or expiration entry. Those facts must be verified against the current FDA Orange Book and patent record. [2]

When does US Patent 11,744,835 expire?

US Patent 11,744,835 issued on September 5, 2023. [3] The enforceable term cannot be determined from the claims alone. A reliable expiration analysis requires the patent's earliest effective nonprovisional priority date, terminal disclaimers, patent-term adjustment, patent-term extension, and any disclaimer or correction affecting term.

The patent number and issue date therefore do not support a precise expiration date without the full USPTO continuity and term records. A diligence model should separately record:

1. Earliest effective priority date.
2. Patent-term adjustment.
3. Terminal disclaimer status.
4. Patent-term extension status.
5. Any continuation or divisional relationship.
6. Orange Book-listed expiration, if applicable.

How strong is the patent estate?

The patent has meaningful product-design leverage but its claim strength is concentrated in a specific implementation.

Strengths

• It combines composition, manufacturing origin, dose, dosage-unit, and inhaler limitations.
• It covers both broad excipient-matrix language and narrower named-excipient claims.
• It reaches particle size, moisture content, capsule delivery, and one-to-two-breath administration.
• It is positioned around a commercial dry-powder inhalation architecture rather than a purely theoretical formulation.

Vulnerabilities

• The claims are technically dense and require many elements to be present simultaneously.
• "About," "substantially uniform," and "predetermined size range" may create claim-construction disputes.
• The solution-origin limitation may be difficult to prove for a competitor's product.
• Dose and concentration limitations can be designed around.
• A competitor could use a different excipient matrix, delivery unit, inhaler architecture, or powder-generation process.
• Claims 3 and 4 contain an apparent range overlap that may invite prosecution-history and claim-construction analysis.

The estate is strongest against a product that intentionally replicates a low-dose treprostinil powder, uses the same capsule-based DPI architecture, employs similar excipients, and matches the claimed aerodynamic and moisture specifications.

What generic entry risks exist?

A generic or follow-on entrant would face several possible launch paths.

Paragraph IV challenge

An ANDA applicant could challenge relevant Orange Book patents through a Paragraph IV certification. The applicant would typically assert that the patent is invalid, unenforceable, or not infringed. The patent owner could file suit within the statutory period, triggering a regulatory stay under applicable Hatch-Waxman rules.

The most credible design-around or invalidity theories would likely focus on:

• Prior art dry-powder treprostinil formulations.
• Obviousness of combining known pulmonary vasodilator dosing with known excipient matrices.
• Indefiniteness of approximate concentration, uniformity, or predetermined-size language.
• Lack of written description or enablement across the full dose and formulation scope.
• Noninfringement based on a different particle-generation process or dosage-unit architecture.

Non-ANDA competitors

A product approved through a different regulatory pathway, or a device-led competitor, could face ordinary patent litigation without the same Orange Book sequence. Such a competitor would need to evaluate formulation, device, manufacturing, and method-of-use claims independently.

Biosimilar risk

Biosimilar risk is not the primary issue. Treprostinil is a small-molecule drug, not a biologic. The relevant competitive pathways are generic, hybrid, 505(b)(2), reformulated, or device-enabled products rather than biosimilars.

What licensing and litigation issues should be monitored?

The supplied information does not establish any license, settlement, Paragraph IV litigation, or federal-court dispute involving US Patent 11,744,835. Patent ownership, exclusive licensing, and enforcement rights should be checked in:

• USPTO assignment records.
• FDA Orange Book listings.
• PACER and district-court dockets.
• ANDA litigation records.
• SEC filings by United Therapeutics and counterparties.
• Published settlement agreements or licensing announcements.

The most commercially relevant litigation would involve an ANDA or 505(b)(2) product asserting noninfringement or invalidity of the dry-powder claims.

How does this patent compare with broader treprostinil patents?

US 11,744,835 is narrower than patents covering treprostinil as a chemical entity or broad methods of treating pulmonary hypertension. Its value lies in the delivery system and formulation combination.

Patent category	Primary risk
Treprostinil compound patents	Active-ingredient exclusivity
Broad method-of-use patents	Treatment of pulmonary hypertension
Inhalation-solution patents	Nebulized treprostinil products
Dry-powder formulation patents	Powder composition and aerosol performance
Device patents	DPI mechanics and dose dispersion
Manufacturing patents	Spray drying, particle engineering, and filling
Packaging patents	Capsules, containers, moisture protection, and dose handling

A freedom-to-operate review should therefore cover the full product stack. Clearance of US 11,744,835 alone would not establish freedom to market a dry-powder treprostinil product.

Key Takeaways

• US 11,744,835 targets dry-powder treprostinil treatments for pulmonary arterial hypertension.
• Claim 1 requires a solution-origin powder containing a pH-modifying agent and bulking agent, DPI-compatible dosage units, and 100 to 350 micrograms of treprostinil.
• Dependent claims add dose-per-unit, powder-mass, concentration, MMAD, excipient, moisture, capsule, breath-count, packaging, and particle-uniformity limitations.
• The strongest infringement scenario involves a Tyvaso DPI-like product using similar powder loading, capsule delivery, aerosol size, and formulation components.
• The patent is not a broad monopoly over inhaled treprostinil. Its scope is concentrated in a particular dry-powder product architecture.
• Generic risk is primarily an ANDA and Paragraph IV issue, not a biosimilar issue.
• A precise expiration date, current Orange Book status, licensing position, and litigation record require verification against the current USPTO, FDA, and court records.

FAQs

Does US 11,744,835 cover all inhaled treprostinil products?

No. It requires a dry-powder formulation, specific dosage-unit characteristics, a solution-based particle-formation limitation, and a defined total treprostinil dose.

Can a product avoid the patent by using a nebulizer?

A nebulized product would generally avoid the dry-powder and dry-powder-inhaler limitations in these claims, although other treprostinil patents may apply.

Does a product infringe if it uses a different excipient from claim 12?

Potentially. Claim 12 requires the listed excipient matrix, but claim 1 does not require that exact matrix. A different excipient does not by itself avoid claim 1.

Are claims 3 and 4 logically inconsistent?

They overlap only in the approximate 100 to 110 microgram range because claim 4 depends on claim 3. The overlap may affect claim construction but does not automatically invalidate either claim.

Is a dry-powder treprostinil competitor exposed if its product has a different MMAD?

Possibly. A different MMAD may avoid claims 9 and 10, but it would not necessarily avoid claim 1 or claims covering dose, concentration, capsules, excipients, manufacturing origin, or moisture.

References

1. U.S. Food and Drug Administration. (2022). Tyvaso DPI (treprostinil) inhalation powder: Prescribing information. Drugs@FDA.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Orange Book.

3. United States Patent and Trademark Office. (2023). U.S. Patent No. 11,744,835. Patent Center.

Drugs Protected by US Patent 11,744,835

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Liquidia Tech	YUTREPIA	treprostinil sodium	POWDER;INHALATION	213005-001	May 23, 2025		RX	Yes	Yes	11,744,835		Y
Liquidia Tech	YUTREPIA	treprostinil sodium	POWDER;INHALATION	213005-002	May 23, 2025		RX	Yes	Yes	11,744,835		Y
Liquidia Tech	YUTREPIA	treprostinil sodium	POWDER;INHALATION	213005-003	May 23, 2025		RX	Yes	Yes	11,744,835		Y
Liquidia Tech	YUTREPIA	treprostinil sodium	POWDER;INHALATION	213005-004	May 23, 2025		RX	Yes	Yes	11,744,835		Y

International Family Members for US Patent 11,744,835

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2017261317
Australia	2023201307
Australia	2025204321
Canada	3023257
European Patent Office	3452170
Israel	262720