Scope, Claim Construction, and U.S. Patent Landscape for Drug Patent US 11,903,993 (Bivalirudin Ready-to-Use Liquid)

What is US 11,903,993 claiming in scope terms?

US 11,903,993 claims a specific method of administering bivalirudin using a ready-to-use intravenous liquid composition with defined formulation parameters and defined preparation and stability attributes.

At a high level, the independent claim (Claim 1) ties together four elements that constrain scope: 1) Drug form and concentration: bivalirudin (or salt) at ~5 mg/mL in a ready-to-use liquid. 2) Formulation composition: sodium acetate trihydrate ~0.8 mg/mL and PEG 400 ~100 mg/mL, with water and optional pH tools (glacial acetic acid and/or sodium hydroxide). 3) Product parameters: pH ~5.25 and osmolality ~200 to ~600 mOsm/kg. 4) Preparation and use constraints: the “ready-to-use” liquid is produced by mixing specified components, and the method of administration uses that composition as-is.

The dependent claims tighten scope around:

Impurity growth over storage (Claim 2)
Cold storage conditions (Claim 3)
Salt identity (Claim 4)
Clinical indication and procedure context (Claim 5)
No redispersion/dilution from other dosage forms (Claim 6)

This is a formulation-and-process-to-use pathway that is narrower than broad “bivalirudin injection” patents, because it is constrained by composition ranges, pH/osmolality targets, and storage/impurity behavior.

What are the core elements of Claim 1 (independent claim) and how do they limit infringement?

1) Method of administration

Claim 1 is a method-of-use claim, but infringement depends on using a particular composition. It requires:

“administering to the patient intravenously”
administering a ready-to-use liquid composition with the stated formulation and product parameters.

2) “Ready-to-use liquid composition” formulation limits

Claim 1 specifies:

About 5 mg/mL bivalirudin or a salt thereof
About 0.8 mg/mL sodium acetate trihydrate
About 100 mg/mL PEG 400
Water
Optional glacial acetic acid and/or sodium hydroxide (for pH adjustment)

3) Product parameters: pH and osmolality

The ready-to-use composition has:

pH of about 5.25
osmolality of about 200 to about 600 mOsm/kg

These are hard technical boundaries because they constrain the formulation environment. A competing product that uses a different buffer system, different PEG concentration, different target pH, or different osmolality could fall outside literal scope.

4) Preparation method requirement

Claim 1 defines how the ready-to-use composition is prepared:

“mixing bivalirudin or salt thereof, sodium acetate, PEG 400, and water”
optionally adding glacial acetic acid and/or sodium hydroxide

The claim is drafted to require that exact mixing-based preparation pathway for the ready-to-use product.

5) Interlocking limitation: “ready-to-use” plus composition constraints

The claim’s “ready-to-use” language matters because Claim 6 separately adds an explicit “not reconstituted / not diluted from other forms” limitation. Even if a competitor has the same final concentrations, sourcing into the same final composition via reconstitution from a lyophilized cake or dilution from a concentrate is positioned to avoid Claim 1 via the dependent narrowing (and potentially via claim construction).

What do the dependent claims add (Claims 2 to 6) and where do they create design-around options?

Claim 2: impurity growth threshold over shelf-life

Claim 2 limits stability/quality:

“percentage of total impurities increases by no more than about 9% from the time of manufacture up to 12 months at 5°C”
measured by HPLC at 215 nm

Implication for scope: Even if a competitor matches concentrations, pH, and osmolality, failing the impurity growth limit is a non-infringement path for the asserted dependent claim.

Design-around lever:

Reformulate or adjust process to reduce formation of impurities to fall outside the “no more than 9%” condition (or, depending on legal posture, argue measurement differences, but the claim text ties to the same HPLC wavelength and metric).

Claim 3: storage condition

“stored at 2-8°C prior to administration”

This is a narrower manufacturing/distribution constraint. If a competitor’s product is stored outside 2-8°C (or claim requires a particular storage step in method practice), that can be a contestable limitation.

Claim 4: bivalirudin salt form

bivalirudin is in the form of a trifluoroacetate salt

This can be a major scope divider:

If the asserted claim set includes Claim 4, a product using bivalirudin in another salt form (or free base where such exists for bivalirudin in a stable formulation) would not meet this dependent limitation.

Claim 5: clinical context (HIT/HITTS undergoing PCI)

patient has heparin-induced thrombocytopenia (HIT) and/or HIT with thrombosis syndrome (HITTS)
undergoing percutaneous coronary intervention (PCI)

This provides indication and procedure context. It is not just “bivalirudin for patients who need it.” It is a defined clinical use case.

Claim 6: “not reconstituted from lyophilized or diluted from liquid concentrate”

composition “has not been reconstituted from a lyophilized composition or diluted from a liquid concentrate”

This is the most direct “manufacturing channel” limitation:

It targets “two-step” workflows (lyo + reconstitution; concentrate + dilution).
It supports enforcement against ready-to-use single-step IV products, even if the final mixture matches.

What is the effective claim chart of US 11,903,993 (what must exist for infringement)?

Below is the practical “elements must be present” structure.

Claim element	What is required (literal scope anchor)
Administration type	“Method… comprising intravenously administering”
Composition status	“ready-to-use liquid composition”
Bivalirudin content	~5 mg/mL bivalirudin or salt
Buffer/acid-salt system	~0.8 mg/mL sodium acetate trihydrate
Excipients	~100 mg/mL PEG 400; water
Optional pH agents	optional glacial acetic acid and/or sodium hydroxide
pH	about 5.25
Osmolality	about 200 to about 600 mOsm/kg
Preparation	mixing bivalirudin (or salt), sodium acetate, PEG 400, and water, plus optional pH agents
Stability (dependent)	impurity increase ≤ ~9% over 12 months at 5°C (HPLC 215 nm)
Storage (dependent)	stored at 2-8°C prior to administration
Salt form (dependent)	trifluoroacetate salt
Clinical use (dependent)	HIT/HITTS undergoing PCI
Dosage workflow (dependent)	not reconstituted from lyophilized; not diluted from a concentrate

How does this claim set compare to typical bivalirudin IP patterns (what is narrowed here)?

Most bivalirudin patent families historically cluster into three broad buckets: 1) Use patents: bivalirudin in specified indications or combinations. 2) Molecule/salt patents: specific salt forms and their properties. 3) Product/process patents: stable formulations, buffers, excipients, and manufacturing methods.

US 11,903,993 is a product formulation-to-administration claim. It narrows the “product” bucket with:

a defined PEG 400 loading (~100 mg/mL),
a defined sodium acetate trihydrate loading (~0.8 mg/mL),
defined pH and osmolality targets,
and a “no reconstituted/diluted workflow” limitation (Claim 6).

This combination is more restrictive than patents that only recite general buffer choice or general “ready-to-use” without numerical pH/osmolality/PEG constraints.

Scope map for enforceability: which competitors are at highest risk?

Risk concentrates on products that match the full set of Claim 1 limitations, with increasing specificity for dependent claims.

Highest-risk scenario (matches all core Claim 1 anchors)

Ready-to-use IV liquid
bivalirudin (or salt) at ~5 mg/mL
sodium acetate trihydrate ~0.8 mg/mL
PEG 400 ~100 mg/mL
pH ~5.25
osmolality 200-600 mOsm/kg
made by mixing those listed components
stored 2-8°C
impurity growth within the Claim 2 threshold (if that dependent claim is asserted)

Medium-risk scenario (matches Claim 1 but not dependent claims)

If PEG/buffer/pH/osmolality match but:
- stored outside 2-8°C, or
- impurity growth exceeds the threshold, or
- dosing context differs from HIT/HITTS undergoing PCI, or
- salt form differs from trifluoroacetate, then infringement may depend on which claim(s) are asserted.

Lower-risk scenario (process/workflow differs)

If the final product matches composition targets but is reconstituted from lyophilized powder or diluted from a liquid concentrate, Claim 6 can reduce risk.

Patent landscape for US 11,903,993: what patents typically sit around it (and where disputes usually form)

A complete U.S.-only landscape requires family mapping across:

formulation patents on bivalirudin ready-to-use liquids,
bivalirudin salt form patents (including trifluoroacetate),
stability/impurity measurement patents,
and indication/procedure use patents for HIT/HITTS and PCI.

This claim set indicates the landscape is likely anchored by:

Formulation patents around PEG 400 and sodium acetate-based buffers for bivalirudin stability.
Salt-form patents that support compatibility with specific counterions (Claim 4).
Stability methods that define impurity increases over defined storage temperatures and time.
Ready-to-use product channel distinctions vs lyophilized and concentrate workflows (Claim 6).
Clinical use patents for HIT/HITTS and PCI (Claim 5), though that clinical context is typically also covered by broader bivalirudin use/IP and labeling-derived claims.

However, no publication-number or family identifiers beyond the user-provided claim text are present here. Without those, a definitive citation-grade mapping of specific neighboring U.S. patents, assignees, priority dates, and expiration timelines cannot be produced from the provided data alone.

Accordingly, the actionable landscape conclusion is limited to claim-architecture proximity rather than a numbered list of specific patents.

What are the most actionable design-around levers?

Below are levers implied directly by the claim language, ordered by how directly they affect literal scope.

1) Change PEG 400 level or replace PEG 400

Claim 1 requires “about 100 mg/mL PEG 400.” Moving meaningfully away from that or using a different polymer can miss the literal range.

2) Change buffer system away from sodium acetate trihydrate at the stated level

“about 0.8 mg/mL sodium acetate trihydrate” is a numeric limiter.

3) Move pH away from about 5.25

Changing pH profile through different acids/bases or buffer capacity can miss the pH target.

4) Change osmolality outside about 200 to about 600 mOsm/kg

Osmolality control via tonicity agents can be used as a boundary.

5) Use a different dosage workflow

Claim 6 blocks compositions “reconstituted from lyophilized” and “diluted from a liquid concentrate.” A two-step path can reduce applicability.

6) Use a different salt form

Claim 4 depends on trifluoroacetate. Using another counterion can defeat that dependent limitation.

7) Fail or exceed impurity growth threshold (if asserting dependent claim)

Claim 2 uses a specific stability metric: total impurity % increase over 12 months at 5°C, measured by HPLC at 215 nm.

8) Constrain clinical use

Claim 5 narrows to HIT/HITTS undergoing PCI. Different indication pathways can reduce reliance on that dependent claim.

Key Takeaways

US 11,903,993 is a ready-to-use IV formulation and administration method anchored to: ~5 mg/mL bivalirudin, ~0.8 mg/mL sodium acetate trihydrate, ~100 mg/mL PEG 400, with pH ~5.25 and osmolality 200-600 mOsm/kg.
Scope tightens through dependent claims to include: impurity growth ≤ ~9% over 12 months at 5°C (HPLC 215 nm), storage at 2-8°C, trifluoroacetate salt, HIT/HITTS undergoing PCI, and a strict “not reconstituted/diluted” workflow.
Design-around is most feasible by altering PEG/buffer/pH/osmolality, shifting to lyo or concentrate workflows, or using a non-trifluoroacetate salt.
A full U.S. patent landscape with identified competing patents and expiration windows cannot be enumerated from the provided information because family identifiers and specific citing documents are not present.

FAQs

1) Does US 11,903,993 claim bivalirudin itself?

No. It claims a method of administering a specified ready-to-use liquid composition containing bivalirudin at defined concentrations and formulation parameters.

2) Is PEG 400 required for infringement under Claim 1?

Yes. Claim 1 requires “about 100 mg/mL PEG 400” in the ready-to-use liquid composition.

3) Can a lyophilized product be outside scope even if the final mixture matches?

Yes. Claim 6 excludes compositions that are “reconstituted from a lyophilized composition” or “diluted from a liquid concentrate.”

4) What stability metric does Claim 2 impose?

Claim 2 requires total impurities to increase by no more than about 9% after 12 months at 5°C, measured by HPLC at 215 nm.

5) Does Claim 5 limit use only to HIT/HITTS patients undergoing PCI?

Yes. Claim 5 requires the patient has HIT and/or HITTS and is undergoing percutaneous coronary intervention (PCI).

References

[1] User-provided claim text for United States Drug Patent 11,903,993 (Claims 1-6).

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Maia Pharms Inc	ANGIOMAX RTU	bivalirudin	SOLUTION;INTRAVENOUS	211215-001	Jul 25, 2019		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				USE AS AN ANTICOAGULANT IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI)	⤷ 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

Details for Patent: 11,903,993

Which drugs does patent 11,903,993 protect, and when does it expire?

Summary for Patent: 11,903,993