Scope, Claims, and US Patent Landscape for Drug Patent US 12,409,184

US Patent 12,409,184 claims a tightly defined “pre-dilution” aqueous formulation of iloprost with tromethamine (Tris buffer), sodium chloride, and ethanol at pH about 8 to 9, which is then diluted about 100-fold before injection. The invention is framed around stability (up to 4 hours at 20 C to 25 C) and practical delivery (IV infusion and kit-based dilution).

What does US 12,409,184 claim in plain scope terms?

What is the core claimed formulation?

Claim 1 is the independent claim and defines four substance inputs, a pH window, a dilution ratio, and a stability window:

Iloprost: about 0.1 mg/mL in the pre-dilution formulation
- Includes pharmaceutically acceptable salt(s) and stereoisomer(s)
Tromethamine (Tris base): about 0.24 mg/mL in the pre-dilution formulation
Sodium chloride: present (amount not fixed in Claim 1)
Ethanol: present (amount not fixed in Claim 1)
pH: about 8 to about 9 (pre-dilution formulation)
Dilution prior to injection: about 100-fold
Stability: composition for injection is stable up to 4 hours at 20 C to 25 C

This positions the protected “composition” as the pre-dilution formulation plus its required method-of-use dilution into an injection bag (the claim ties stability to the diluted product).

What is the claimed concentration after dilution?

Dependent Claim 2 pins the diluted concentration:

Iloprost in the injection composition: about 1 μg/mL

This is consistent with 0.1 mg/mL pre-dilution then 100-fold dilution:
0.1 mg/mL = 100 μg/mL, divided by 100 = 1 μg/mL.

What injection volume mapping is claimed?

Dependent Claim 3 specifies a typical dilution setup:

1 mL of pre-dilution formulation into 100 mL of 0.9% sodium chloride

So “about 100-fold” dilution is operationalized as a 1 mL into 100 mL scheme.

How is the product used?

Dependent Claim 4 states:

composition is for intravenous infusion

So the intended route is IV infusion, not bolus injection or other parenteral forms.

Where is the real claim value: formulation vs. packaging?

US 12,409,184 has two claim “clusters”:

Formulation chemistry + stability (Claims 1–4, 9–12, plus Claim 10/11)
Delivery kit construction (Claims 5–8)

What does the kit protect?

Claims 5–8 add a combination claim:

Claim 5: a kit comprising:
- the pre-dilution formulation of Claim 1; and
- an IV bag containing 0.9% sodium chloride for diluting
Claim 6: IV bag contains about 100 mL of 0.9% sodium chloride
Claim 7: IV bag is made of PVC

This means a commercial “program” that sells the product as a two-component kit could fall inside kit protection even if the underlying chemistry is the same as a competitor, assuming the competitor uses the same defined pre-dilution formulation.

What does the single-use vial protect?

Claim 8 narrows presentation:

pre-dilution formulation is provided as a single-use vial
each vial contains about 1 mL

This is a packaging limitation that can matter for both marketing and design-around strategies.

Claim-by-claim coverage map

Claims 1–4: Independent chemical and use claim core

Claim	Type	Key limitations	Practical implication
1	Independent	iloprost ~0.1 mg/mL; tromethamine ~0.24 mg/mL; sodium chloride; ethanol; pH ~8 to ~9; diluted ~100-fold; stability up to 4 hours at 20 C–25 C	Covers the formulation and its required dilution/stability profile
2	Dependent	injection concentration about 1 μg/mL iloprost	Locks the target infusion strength
3	Dependent	1 mL into 100 mL of 0.9% NaCl	Locks a dilution workflow consistent with “100-fold”
4	Dependent	for IV infusion	Route limitation reduces applicability to other parenteral methods

Claims 5–8: Delivery kit limitations

Claim	Type	Key limitations	Practical implication
5	Dependent	kit with pre-dilution formulation + IV bag with 0.9% NaCl	Combination protection for marketed kit structure
6	Dependent	IV bag about 100 mL	Further narrows kit configuration
7	Dependent	IV bag is PVC	Design-around could use alternative plastics (as long as chemistry also avoids Claim 1)
8	Dependent	single-use vial; ~1 mL per vial	Presentation limitation

Claims 9–12: Additional formulation constraints

Claim	Type	Key limitations	Practical implication
9	Dependent	tromethamine about 0.242 mg/mL	Tightens the buffer amount to a specific value
10	Dependent	pre-dilution formulation is sterile solution	Operationalizes manufacturing spec
11	Dependent	pre-dilution formulation has no preservatives	Excludes preservative-containing variants
12	Dependent	sodium chloride about 9.0 mg/mL in pre-dilution formulation	Pins NaCl level (important for osmolality and stability)

Coverage signal: Claim 12 strongly suggests the specification targets a particular ionic strength and tonicity range. Combined with pH and ethanol, this indicates a designed solubilization and stability envelope.

What is the effective patent “scope” for competitors?

How close do products have to be to infringe Claim 1?

A product must, in substance, match all Claim 1 anchor features:

iloprost at about 0.1 mg/mL in the pre-dilution formulation
tromethamine about 0.24 mg/mL
sodium chloride present at a claimed-specific level only if later dependent claims are asserted (but at least “present” is required in Claim 1)
ethanol present
pH about 8 to 9
diluted about 100-fold
injection stability up to 4 hours at 20–25 C

Where claim-by-claim matters:

If a competitor matches the pre-dilution chemistry but produces a more stable injection beyond 4 hours, Claim 1 still reads on “stable up to 4 hours” because the claim sets an upper stability duration, not necessarily an exact stability limit. That said, claim interpretation will turn on whether “stable for up to 4 hours” means “meets stability for at least 4 hours” vs “only stable for up to 4 hours.” The text you provided uses “stable for up to 4 hours,” which commonly reads as “stable for that period.”
If a competitor changes either buffer identity, pH, or dilution ratio, it is the cleanest design-around path.

What changes could avoid the kit claims (Claims 5–8) without changing chemistry?

Even if the formulation matches Claim 1, kit claims can be avoided by changing any required kit component limitation:

use an IV diluent solution other than 0.9% sodium chloride
omit the kit bundling concept (sell separately)
use non-PVC IV bags (depending on Claim 7 coverage)
not provide the pre-dilution formulation as single-use vials of about 1 mL

But note: those design-arounds only address Claims 5–8, not Claim 1.

Most vulnerable axis: the pH and buffer concentration

The tightest “technical fingerprint” is:

pH about 8 to about 9
tromethamine around 0.24–0.242 mg/mL
ethanol present (amount unspecified in Claim 1, but presence is required)

Competitors that formulate iloprost injection solutions without tromethamine, or at a different pH system, reduce the likelihood of Claim 1 read-through.

Patent landscape: likely positioning vs. iloprost formulation art

With only the claims provided and without bibliographic data for the family (filing dates, assignees, related applications, cited references), a defensible “landscape” can still be framed around what this patent is trying to own:

Combination of solubilizer/buffer system for iloprost injections
- iloprost + tromethamine + ethanol + defined pH
Pre-dilution concept
- protect an intermediate formulation that is diluted shortly before use
Stability after dilution at room temperature
- “stable up to 4 hours at 20 C to 25 C” ties formulation to a practical use window
Standard IV infusion workflows packaged as kits
- 1 mL into 100 mL of 0.9% NaCl in PVC bags

How this typically overlaps with earlier formulation patents

Iloprost formulation patents commonly cover: stabilizers, pH adjustment, cosolvents, and container compatibility. This patent’s distinctive overlap points are:

the explicit inclusion of tromethamine at a specific concentration
the stated pH window 8–9 for the pre-dilution formulation
the ethanol presence combined with that pH system
the procedural “dilute about 100-fold” with a measured stability window

If earlier patents disclosed iloprost injection concentrates and stability, this patent attempts to tighten around a specific buffer system and a pre-dilution-to-injection workflow.

Competitive risk map by product type

Concentrate sold in a vial that is later diluted in an infusion bag: higher risk if it uses tromethamine + ethanol + pH 8–9 and matches injection stability.
Ready-to-infuse dilutions: lower risk for Claim 1’s “pre-dilution formulation” structure, but still possibly exposed if the product concept effectively contains the same pre-dilution chemistry behind the scenes (depends on how the ready-to-use composition is generated and what exact composition exists in the final container).
Non-kitted distribution: reduces exposure to Claims 5–8 but not necessarily to Claim 1.

Practical implications for R&D and licensing strategy

If you are developing a competing iloprost infusion program

The technical path to avoid Claim 1 is to change at least one anchor limitation:
- avoid the defined tromethamine concentration range
- avoid pH 8–9 for the pre-dilution concentrate
- avoid the “about 100-fold” dilution workflow as claimed
- avoid the 4-hour stability profile for the diluted composition at 20 C to 25 C
If you must match Claim 1 chemistry, then packaging and workflow changes may only partially mitigate risk by steering clear of Claims 5–8 and Claim 8.

If you are licensing or investing

Claim 1 is broadest and drives exclusivity economics because:

it is an independent claim tied to formulation identity and stability after dilution
kit claims are narrower but add commercial leverage for bundled sales
dependent claims add “hard” operational constraints (IV infusion, 1 mL into 100 mL, PVC bags, no preservatives)

That combination tends to raise enforcement leverage against “marketed” products that replicate both the chemistry and the usability workflow.

Key Takeaways

US 12,409,184 protects a specific iloprost pre-dilution concentrate system: iloprost ~0.1 mg/mL with tromethamine ~0.24 mg/mL, sodium chloride and ethanol, at pH about 8 to 9.
The claim is anchored to an administration workflow: the pre-dilution concentrate is diluted about 100-fold to an injection strength of about 1 μg/mL iloprost for IV infusion.
The stability constraint matters: the diluted injection is stable up to 4 hours at 20 C to 25 C, linking formulation to room-temperature usability.
Commercial packaging is part of the scope: kit claims require an IV bag with 0.9% NaCl (about 100 mL) and, in one dependent claim, a PVC bag, plus a single-use 1 mL vial configuration.
Design-around emphasis: changing the buffer system (tromethamine), the pH window, or the dilution/stability profile is the most direct route to reducing Claim 1 exposure.

FAQs

1) What is the dilution relationship embedded in the claims?

Claim 1 requires dilution “about 100-fold.” Claim 3 operationalizes that as 1 mL pre-dilution into 100 mL of 0.9% sodium chloride.

2) What exact iloprost concentration is claimed in the infusion solution?

Claim 2 requires about 1 μg/mL iloprost in the composition for injection.

3) Does the patent claim a ready-to-use infusion or a concentrate?

It claims a pre-dilution formulation (concentrate) that is diluted prior to injection to form the final composition.

4) What does the stability requirement cover?

It covers the composition for injection being stable up to 4 hours at 20 C to 25 C.

5) Can a competitor avoid the kit claims by changing container material?

Claim 7 requires PVC for the IV bag. Changing bag material can avoid Claim 7, but it does not avoid Claim 1 if the formulation and stability limits match.

References

US Patent 12,409,184 (claims as provided by user).

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Btg Intl	AURLUMYN	iloprost	SOLUTION;INTRAVENOUS	217933-001	Feb 13, 2024		RX	Yes	Yes	12,409,184	⤷ Start Trial	Y				⤷ 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
World Intellectual Property Organization (WIPO)	2022032141	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 12,409,184

Which drugs does patent 12,409,184 protect, and when does it expire?

Summary for Patent: 12,409,184