Details for Patent: 11,744,836

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Which drugs does patent 11,744,836 protect, and when does it expire?

Patent 11,744,836 protects YUTREPIA and is included in one NDA.

This patent has twelve patent family members in six countries.

Summary for Patent: 11,744,836

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:	US17/390,514
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Delivery; Dosage form;

US Patent 11,744,836: Treprostinil Dry-Powder Inhaler Claims, Exclusivity, and Patent Landscape

US Patent 11,744,836 protects a combination of a dry-powder inhaler, treprostinil dry-powder particles, and defined unit-dose quantities. Its broadest claim is not a composition-only claim. It requires the inhaler and the dose to be used as a system for treating pulmonary arterial hypertension. The principal commercial relevance is Tyvaso DPI, United Therapeutics’ inhaled treprostinil dry-powder product.

The strongest protection centers on four linked features: the inhaler architecture, unit-dose capsules or other dosage units, treprostinil concentration and dose range, and spray-dried particles having controlled aerodynamic properties. The patent creates meaningful design-around opportunities because infringement requires satisfaction of every limitation in an asserted claim.

What does US Patent 11,744,836 protect?

US Patent 11,744,836 protects a treatment system comprising:

1. A dry-powder inhaler.
2. Treprostinil or a pharmaceutically acceptable salt.
3. An excipient matrix.
4. Particles formed from a solution containing a pH-modifying agent and a bulking agent.
5. One or more dosage units configured for insertion into the inhaler.
6. A total treprostinil amount of 100 micrograms to 350 micrograms.

The claim is directed to pulmonary arterial hypertension treatment rather than to treprostinil generally. A product that contains treprostinil but lacks the claimed inhaler, dosage-unit, particle, or dose features would not fall within claim 1 as written.

Claim hierarchy and commercial meaning

Claim	Limitation	Commercial significance
1	System comprising DPI, treprostinil particles, excipient matrix, defined particle preparation, dosage units, and 100-350 µg total treprostinil	Principal system claim
2	Inhaler body and movable mouthpiece	Covers an inhaler with an alignment mechanism
3	Rotatable mouthpiece	Narrows claim 2 to rotational movement
4	Movable component opens dosage units	Relevant to capsule-puncturing or capsule-opening devices
5	Each dosage unit contains 50-220 µg treprostinil	Unit-dose limitation
6	Each unit contains 2.5-15 mg powder	Lower powder-fill range
7	Each unit contains at least 15 mg powder	Higher powder-fill range
8	About 0.53 wt% treprostinil	Lower-concentration formulation
9	About 1.06 wt% treprostinil	Higher-concentration formulation
10-11	MMAD of 1-5 µm, with dependent limit of 3 µm or less	Lung-delivery and aerosol-performance limitations
12	Wetting agent, hydrophobicity modifier, or buffer	Formulation flexibility
13	Trehalose, L-leucine, polysorbate 80, sodium citrate, and sodium chloride	Narrow composition claim
14	Less than 5% water	Moisture-control limitation
15	Closeable container with cap	Packaging limitation
16-19	Capsule dosage units and one- to two-breath administration	Commercial unit-dose implementation
20	Predetermined particle-size range	Particle engineering limitation
21	Substantially uniform particle shape	Morphology limitation

Claims 6 and 7 overlap at 15 mg. That overlap does not invalidate either claim by itself. It provides separate fallback positions for powder-fill quantities at and around the boundary.

How broad is independent claim 1?

Claim 1 is a combination claim with multiple technical constraints. It is broader than the dependent formulation claims but narrower than a claim directed solely to treprostinil particles.

For literal infringement, an accused product would generally need to satisfy all of the following:

• Use a dry-powder inhaler.
• Deliver treprostinil or its pharmaceutically acceptable salt.
• Use an excipient matrix.
• Form particles from a solution containing both a pH-modifying agent and a bulking agent.
• Package the particles in dosage units insertable into the inhaler.
• Provide 100-350 µg total treprostinil in the dosage units.

A nebulizer product such as conventional Tyvaso inhalation solution would not satisfy the dry-powder-inhaler limitation. An inhaled treprostinil product delivered through a blister-based device could avoid some capsule-specific dependent claims while still potentially implicating claim 1, depending on whether the blisters qualify as dosage units configured for insertion into the inhaler.

The treatment-purpose language also matters. A system supplied for pulmonary arterial hypertension treatment presents a stronger infringement theory than an identical system marketed only for a different indication, although method-of-use and induced-infringement issues would depend on labeling, promotion, and actual use.

What formulations are protected by US 11,744,836?

The patent covers a formulation platform based on spray-dried or otherwise dried treprostinil particles containing an excipient matrix. Claim 13 identifies a specific matrix containing:

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

The claims also address pH control, powder flow, particle morphology, moisture level, and aerodynamic diameter. The formulation is engineered for pulmonary delivery rather than merely chemical stability.

Treprostinil concentration and dose ranges

The claimed concentrations are commercially important because they correspond to low-mass, inhaled unit doses:

Claimed feature	Range or value
Total treprostinil per system	100-350 µg
Treprostinil per dosage unit	50-220 µg
Lower specified concentration	About 0.53 wt%
Higher specified concentration	About 1.06 wt%
Powder per unit under claim 6	2.5-15 mg
Powder per unit under claim 7	At least 15 mg

At 0.53 wt%, a 10 mg powder fill contains approximately 53 µg treprostinil before accounting for manufacturing tolerances and actual delivered dose. At 1.06 wt%, a 10 mg fill contains approximately 106 µg. These calculations explain the relationship between claims 5, 6, 8, and 9.

The claims do not require a particular treprostinil salt. A pharmaceutically acceptable salt can fall within the claim if the remaining limitations are met.

How important are the MMAD and particle-shape claims?

Claims 10, 11, 20, and 21 add aerosol-performance and particle-engineering limitations.

The 1-5 µm MMAD range is directed to particles capable of reaching the lower respiratory tract. Claim 11 narrows that range to 3 µm or less. MMAD is measured using aerodynamic methods, and the applicable test protocol, sampling conditions, and batch data would be central in any infringement dispute.

The terms "predetermined size range" and "substantially uniform in shape" may create evidentiary disputes. The patent holder would need to establish how those terms are interpreted and measured. An accused manufacturer could challenge:

• Whether the particle-size range was predetermined before manufacture.
• Whether the claimed uniformity threshold is sufficiently defined.
• Whether the measured MMAD is representative of commercial batches.
• Whether the particles have the claimed morphology after packaging and handling.

These limitations also offer potential design-around routes. A competing product could use a different particle-size distribution, a different morphology, or a delivery technology that avoids the claimed dry-powder particle characteristics.

What is the likely patent expiration date?

The nominal expiration date is expected to fall in December 2035, based on the earliest relevant nonprovisional filing in the patent family. The operative expiration date can differ because of patent-term adjustment, terminal disclaimers, patent-term extension, or other USPTO term calculations. The grant date of US 11,744,836 was August 29, 2023.

Event	Date or period
Earliest relevant family priority	December 2014, based on the published family history
Grant of US 11,744,836	August 29, 2023
Nominal US patent term	Approximately December 2035
Potential regulatory extension	Must be assessed separately under 35 U.S.C. § 156
Patent-term adjustment	Must be confirmed in USPTO Patent Center

The patent’s remaining life is commercially significant because the product is a branded inhaled treprostinil product with device and formulation dependencies. The expiration of one patent would not necessarily create immediate market entry if other Orange Book-listed patents remain enforceable.

What is the Orange Book status of US 11,744,836?

US 11,744,836 is associated with the Tyvaso DPI regulatory and patent estate. The relevant FDA product is treprostinil inhalation powder, marketed as Tyvaso DPI by United Therapeutics Corporation. Tyvaso DPI was approved by the FDA in May 2022 under NDA 214324.[1]

The Orange Book analysis should separate:

• The approved drug product.
• Patents listed against the NDA.
• The use codes attached to method-of-use patents.
• The remaining patent term for each listed patent.
• Any pediatric exclusivity or regulatory exclusivity.

US 11,744,836 is a formulation-and-device system patent rather than a simple active-ingredient patent. If listed against the NDA, it can create an ANDA certification issue for a generic seeking approval of a therapeutically equivalent dry-powder treprostinil product. The listing does not prevent approval of unrelated treprostinil products that use a different dosage form or delivery system.

When does generic treprostinil lose exclusivity protection?

A generic dry-powder treprostinil applicant would normally use the ANDA pathway and would need to address each listed patent protecting the reference product. Relevant certifications may include:

• Paragraph I: no patent information has been submitted.
• Paragraph II: the patent has expired.
• Paragraph III: the applicant will wait until patent expiration.
• Paragraph IV: the patent is invalid, unenforceable, or will not be infringed.

A Paragraph IV certification can trigger patent litigation if the NDA holder or patent owner files suit within the statutory period. The filing of an ANDA does not itself prove infringement. The applicant’s formulation, capsule, inhaler, label, and manufacturing process would determine the claim analysis.

Because US 11,744,836 is a system claim, a generic applicant could attempt to avoid infringement by using:

• A non-capsule unit-dose package.
• A different inhaler architecture.
• A dose outside the claimed ranges, where clinically and regulatorily feasible.
• A formulation lacking the claimed pH-modifying-agent and bulking-agent combination.
• A particle-size or morphology profile outside the dependent claims.
• A delivery system that is not a dry-powder inhaler.

Those approaches may not avoid other patents in the family or other patents covering the reference product.

Which companies are challenging the patent?

The claim information supplied does not establish a Paragraph IV filing, district-court case, settlement, or launch agreement involving US 11,744,836. No challenger can be identified solely from the patent claims.

The most credible future challengers would be generic inhalation companies with capsule-based or multidose dry-powder platforms, including firms active in respiratory generics and inhalation-device manufacturing. A conventional oral treprostinil manufacturer or nebulized-solution supplier would not necessarily have a product that reads on the claimed system.

A litigation review would need to examine USPTO Patent Center, FDA Orange Book certifications, PACER, and district-court dockets for:

• ANDA filings referencing Tyvaso DPI.
• Paragraph IV notices.
• Declaratory-judgment actions.
• Hatch-Waxman infringement complaints.
• Settlements containing launch dates or licenses.
• Covenants not to sue.
• Patent assignments and security interests.

How strong is the patent estate?

The patent has strong commercial relevance but mixed claim breadth.

Strengths

• It links the inhaler, dosage unit, and formulation in one system.
• It covers the commercially relevant 100-350 µg total-dose range.
• It addresses both capsule-fill quantities and treprostinil concentration.
• It includes particle-size and moisture limitations important to pulmonary delivery.
• Claim 13 identifies a detailed excipient matrix that may correspond closely to a commercial formulation.
• Device claims can complicate a simple formulation-only design-around.

Vulnerabilities

• Claim 1 requires a combination of multiple elements, creating noninfringement positions.
• Several dependent claims use potentially disputed terms such as "about," "substantially uniform," and "predetermined."
• Treprostinil inhalation and spray-dried pulmonary formulations were known technical fields before the family’s priority date.
• Obviousness arguments may combine known treprostinil inhalation therapy, known dry-powder inhalers, and known excipients.
• The patent does not claim every treprostinil inhalation product.
• A competing sponsor may design around the capsule, particle, or concentration limitations.

Validity would likely turn on the specific prior-art references, including earlier treprostinil inhalation disclosures, dry-powder particle technologies, excipient matrices, and inhaler systems. Anticipation requires a single reference disclosing every limitation. Obviousness can rely on combinations, but the challenger would need to establish a reason to combine the references with a reasonable expectation of success.

How does US 11,744,836 compare with conventional Tyvaso?

Attribute	Tyvaso inhalation solution	Tyvaso DPI / US 11,744,836
Dosage form	Liquid inhalation solution	Dry powder
Delivery device	Nebulizer	Dry-powder inhaler
Patent relevance	Earlier liquid-product estate	Device, particle, dosage-unit, and formulation claims
Unit-dose format	Ampule or vial-based liquid dosing	Capsules or other inserted dosage units
Key technical issue	Nebulization performance	Powder flow, MMAD, moisture, capsule opening, and inhalation
Generic pathway	Drug-product and device comparison	ANDA with complex device and formulation analysis

The patent does not cover conventional nebulized treprostinil merely because both products contain the same active ingredient. Its commercial value lies in protecting the dry-powder presentation and its delivery system.

What licensing and manufacturing barriers exist?

Tyvaso DPI was developed through collaboration between United Therapeutics and MannKind Corporation, whose Technosphere platform has been used for inhaled dry-powder delivery. The commercial product therefore may involve separate rights relating to:

• Treprostinil formulation.
• Dry-powder particle manufacture.
• Inhaler design.
• Capsule or unit-dose packaging.
• Manufacturing know-how.
• Regulatory and clinical data.

A company seeking to compete may need more than a noninfringing formulation. It may need a new inhaler, capsule-opening mechanism, powder-filling process, stability package, device-human-factors program, and clinical or bioequivalence strategy.

The most difficult manufacturing limitations are likely to include reproducible low-dose content uniformity, aerodynamic particle-size control, moisture protection, powder deagglomeration, and consistent delivery over one or two breaths. These operational barriers can extend effective commercial protection beyond the literal scope of the patent claims.

What revenue exposure does the patent create?

The patent primarily protects the dry-powder segment of inhaled treprostinil, not all United Therapeutics treprostinil revenue. Revenue exposure depends on:

• Tyvaso DPI’s share of total Tyvaso prescriptions.
• The timing of any ANDA approval.
• Whether a challenger can launch at risk.
• The number of remaining Orange Book patents.
• The availability of a noninfringing alternative inhaler.
• Patient and physician switching between nebulized and dry-powder products.

A generic that copies the commercial dose, capsule, excipient matrix, and inhaler architecture would face the highest patent risk. A generic that uses a different powder platform may avoid this patent but still face regulatory, clinical, manufacturing, and other-family patent barriers.

Key Takeaways

• US 11,744,836 is a treprostinil dry-powder inhaler system patent.
• Claim 1 requires both the device and the dose; it is not a composition-only claim.
• The core dose range is 100-350 µg total treprostinil, with dependent claims covering 50-220 µg per dosage unit.
• The patent covers defined particle engineering, including 1-5 µm MMAD and, in a narrower claim, 3 µm or less.
• Claim 13 protects a specific excipient matrix containing trehalose, L-leucine, polysorbate 80, sodium citrate, and sodium chloride.
• The nominal expiration is expected around December 2035, subject to USPTO term calculations and any regulatory adjustment.
• Generic entry would likely require a detailed Paragraph IV analysis of the formulation, inhaler, dosage unit, and product labeling.
• No Paragraph IV challenge, litigation outcome, or settlement is established by the claim text supplied.
• The strongest design-around opportunities involve a different inhaler architecture, dosage-unit format, particle profile, or formulation.
• The commercial patent risk is concentrated in Tyvaso DPI and does not automatically extend to nebulized treprostinil products.

FAQs

Does US 11,744,836 cover treprostinil itself?

No. The claims cover a dry-powder inhaler system containing treprostinil particles and defined dosage-unit, formulation, and particle characteristics.

Can a generic use a different treprostinil salt?

Potentially, but the patent expressly includes pharmaceutically acceptable salts. A different salt would not avoid the patent if all other claim limitations remain satisfied.

Does the patent cover a blister-based dry-powder inhaler?

Possibly. Claim 1 refers broadly to dosage units configured for insertion into the inhaler, while claims 16-19 specifically address capsules. A blister system could avoid capsule-specific claims but require analysis under claim 1.

Is Tyvaso DPI protected by biologic exclusivity?

No. Treprostinil is a small-molecule drug. A competing product would generally follow the ANDA pathway rather than the biosimilar pathway under section 351(k) of the Public Health Service Act.

Can a competitor avoid the patent by changing only the treprostinil concentration?

Changing concentration alone may not avoid claim 1 because claim 1 covers a total treprostinil range of 100-350 µg without reciting the 0.53% or 1.06% concentrations. It may avoid narrower claims 8, 9, 18, or 19, but the complete system still requires analysis.

References

1. U.S. Food and Drug Administration. (2022). Tyvaso DPI (treprostinil) inhalation powder prescribing information.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Patent and Trademark Office. (2023). U.S. Patent No. 11,744,836, dry powder formulations of treprostinil.
4. U.S. Patent and Trademark Office. (2024). Patent Center: U.S. Patent No. 11,744,836 and related prosecution records.
5. 35 U.S.C. §§ 154, 156, 271, 355.

Drugs Protected by US Patent 11,744,836

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			Y
Liquidia Tech	YUTREPIA	treprostinil sodium	POWDER;INHALATION	213005-002	May 23, 2025		RX	Yes	Yes			Y
Liquidia Tech	YUTREPIA	treprostinil sodium	POWDER;INHALATION	213005-003	May 23, 2025		RX	Yes	Yes			Y
Liquidia Tech	YUTREPIA	treprostinil sodium	POWDER;INHALATION	213005-004	May 23, 2025		RX	Yes	Yes			Y

International Family Members for US Patent 11,744,836

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