United States Patent 9,717,796: Scope, Claims, and US Landscape for Sterile Premixed Dexmedetomidine in DEHP-Substantially Free Plastic
United States Patent 9,717,796 is directed to a ready-to-use, premixed, sterile dexmedetomidine solution packaged in plastic containers that are “substantially free of DEHP” (di(2-ethylhexyl) phthalate). The claim set narrows around (i) dexmedetomidine concentration ranges, (ii) specific formulation systems (dexmedetomidine plus sugar with water), (iii) container material structures (inner layers such as ethylene-vinyl acetate or ethylene-propylene and SEBS), and (iv) sterilization/handling modalities (moist steam sterilization and aseptic sterilization).
What does the core independent claim cover?
Claim 1 is the independent claim and defines the invention’s commercial boundary:
- A premixed, ready to use sterile dexmedetomidine solution comprising:
- dexmedetomidine
- a sugar
- in a plastic container
- substantially free of DEHP
This is a formulation-and-packaging claim. The protected subject matter is not simply dexmedetomidine in solution; it is dexmedetomidine plus a sugar in an engineered DEHP-minimized plastic container, provided as a sterile, ready-to-use product.
Claim 1’s key scope levers
- Product form: “premixed” and “ready to use” (excludes kits requiring on-site mixing).
- Sterility: “sterile.”
- Composition: dexmedetomidine + sugar (broad sugar selection is handled in dependent claims).
- Packaging constraint: “plastic container substantially free of DEHP.”
- No container geometry limit in Claim 1: the specific container types show up in dependent claims (ampule/vial/syringe).
What are the measurable formulation boundaries?
Claims 2 to 4 establish dexmedetomidine concentration ranges and formulation system constraints.
Dexmedetomidine concentration range (Claims 2, 3, 10, 16, 14)
- Claim 2: dexmedetomidine at about 0.5 to about 20 μg/mL
- Claim 3: dexmedetomidine at between about 4 to 6 μg/mL
- Claim 10: dexmedetomidine at about 4.0 μg/mL
- Claim 14: isotonic solution with dexmedetomidine between about 4 to 7 μg/mL
- Claim 16: dexmedetomidine hydrochloride at about 4.7 μg/mL
- Claim 11 links sugar concentration to a specific system: dextrose about 50 mg/mL
Business implication: the claim set is concentrated around low single-digit μg/mL dexmedetomidine strengths. The overlap between Claims 3, 10, and 14 is tight enough that product formulating around common infusion concentrations is likely within the claim envelope if the DEHP packaging language is met.
Composition “consists essentially of” (Claim 4)
- Claim 4: the solution “consists essentially of dexmedetomidine, dextrose and water.”
This is not “comprising.” The “consists essentially of” language typically limits additional ingredients to those that do not materially affect basic and novel properties. Here, the baseline system is explicitly dexmedetomidine + dextrose + water.
Isotonic requirement (Claim 14)
- Claim 14: the solution is isotonic, dexmedetomidine between about 4 to 7 μg/mL.
Business implication: an isotonicity specification can become both a gate for design-around (if strict) and an assay focus for enforcement (if optional in practice but required by claim).
What sugar systems are covered?
- Claim 8: sugar selected from:
- dextrose
- mannitol
- glycerol
- sucrose
But the tightest formulation claim is Claim 4 where the system is “consists essentially of” dextrose and water.
-
Claim 11: dextrose at about 50 mg/mL (with dexmedetomidine concentration tied to Claim 9/3 via dependency structure; as written, Claim 11 depends from Claim 9).
-
Claim 15: isotonic solution (Claim 14) where the sugar is dextrose.
Net effect:
- Breadth exists through Claim 8 (mannitol, glycerol, sucrose).
- Enforceable composition narrowing is strongest where the formulation is explicitly dextrose + water and where consists essentially of locks the ingredient set.
What container material and DEHP restrictions matter most?
The patent ties the invention to plastic containers substantially free of DEHP, with additional dependent constraints on container internals.
Flexible container (Claim 5) and container type (Claim 12)
- Claim 5: plastic container is flexible
- Claim 12: plastic container is an ampule, vial or syringe
These appear in different dependency paths in your claim text; together they suggest that the inventors targeted both flexible formats and common injectable unit-dose container geometries, while maintaining the DEHP limitation.
Inner layer polymer structures (Claims 6 and 13)
Two inner-layer options are claimed:
- Claim 6: inner layer comprises a copolymer of ethylene and vinyl acetate (EVA)
- Claim 13: inner layer comprises a copolymer of:
- ethylene-propylene, and
- Styrene-ethylene-butylene-styrene (SEBS)
Business implication: enforcement can track the presence of these polymer systems in the container’s inner layer, not merely a general “DEHP-free” spec. If a competitor uses a different inner layer or barrier film, they may avoid these dependent claim structures while still potentially falling under Claim 1 if DEHP is still substantially absent and the formulation matches.
Sterilization and aseptic processing constraints
Two dependent claim paths address sterilization modalities:
- Claim 7: sterilized in moist steam
- Claim 9: solution has been aseptically sterilized
Business implication: the patent can support multiple enforcement theories depending on manufacturing method. A competitor who sterilizes by different validated methods (if those lead to non-overlap with “moist steam” or “aseptic sterilization” as claim-anchored) may reduce risk for those dependent claims, while the independent Claim 1 may still be asserted as long as the product is “sterile” and packaged as required.
How the dexmedetomidine salt form is treated
- Claim 16: dexmedetomidine is dexmedetomidine hydrochloride with amount about 4.7 μg/mL.
This introduces a salt-form specific anchor. If a competitor uses a different salt or base form, they may still fall under broader claims that do not specify salt form, but Claim 16 is directly targeted to the hydrochloride at a particular strength.
Scope map: claim-by-claim coverage
The following table converts the claim text you provided into product-design elements.
| Claim |
What is claimed (operative limitations) |
Primary commercial implication |
| 1 |
Premixed, ready-to-use, sterile dexmedetomidine + sugar in plastic container substantially free of DEHP |
Broadest protected product: formulation + DEHP-minimized plastic packaging + sterility/ready-to-use |
| 2 |
Dexmedetomidine about 0.5 to 20 μg/mL |
Strength range boundary |
| 3 |
Dexmedetomidine 4 to 6 μg/mL |
Tightens to common low-dose strengths |
| 4 |
Solution “consists essentially of dexmedetomidine, dextrose, water |
Strong ingredient lock (limits other excipients) |
| 5 |
Plastic container is flexible |
Container format limitation |
| 6 |
Inner layer ethylene-vinyl acetate copolymer |
Specific materials design point |
| 7 |
Sterilized in moist steam |
Process-specific dependent claim |
| 8 |
Sugar is dextrose, mannitol, glycerol, or sucrose |
Broad sugar selection |
| 9 |
Aseptically sterilized |
Process-specific dependent claim |
| 10 |
Dexmedetomidine about 4.0 μg/mL |
Fixed-point formulation |
| 11 |
Sugar is dextrose at about 50 mg/mL |
Quantified dextrose anchor |
| 12 |
Container is ampule, vial or syringe |
Common unit-dose formats anchor |
| 13 |
Inner layer comprises ethylene-propylene + SEBS copolymer |
Specific materials design point |
| 14 |
Solution isotonic, dexmedetomidine 4 to 7 μg/mL |
Adds isotonicity and expands upper strength limit |
| 15 |
Sugar is dextrose (under Claim 14) |
Narrows Claim 14’s sugar choice |
| 16 |
Dexmedetomidine is HCl, about 4.7 μg/mL |
Salt + strength anchor |
Where are the infringement “hot zones”?
The hottest areas are where multiple claim levers converge:
- Ready-to-use sterile dexmedetomidine packaged in a DEHP-substantially-free plastic container.
- Dexmedetomidine concentrations around 4 to 6 μg/mL, especially about 4.0 μg/mL or about 4.7 μg/mL.
- Dextrose-based solutions with water, potentially falling under “consists essentially of” if formulation stays within that excipient envelope.
- Inner layer polymer match to EVA or ethylene-propylene/SEBS structures if those dependent claims are asserted.
- Manufacturing method matching moist steam or aseptic sterilization.
Design-around levers (claim-based, not legal advice)
From the claim text alone, the main technical design-around opportunities are:
- Container DEHP profile: If the formulation is in a plastic container that is not “substantially free of DEHP,” Claim 1’s packaging limitation is undermined.
- Inner layer polymer: Using container inner layers outside EVA and outside the ethylene-propylene/SEBS structures may avoid dependent claims 6 and 13 even if DEHP is low.
- Formulation system: Avoiding “consists essentially of dexmedetomidine, dextrose and water” by introducing excipients that materially change composition can reduce fit with Claim 4 (and thereby weaken a key dependent scaffold).
- Strength and isotonicity: Operating outside about 4 to 7 μg/mL or failing isotonic criteria can reduce coverage for Claims 3/14/15.
- Salt form: Using a different salt form can reduce fit with Claim 16, though broader claims may still capture the base act if salt is not limited.
US patent landscape: what this claim set implies
You supplied only the claims, not the patent record, priority dates, assignee, prosecution history, citations, or expiration schedule. Without those, a complete US landscape map (competing patents, blocking families, or expiry status across relevant competitors) cannot be produced accurately.
What can be stated from claim structure is the likely landscape focus areas for competitors and litigants:
- DEHP-reduced packaging for injectable solutions: patents often concentrate on barrier layers and plastic inner liners.
- Premixed dexmedetomidine ready-to-use formulations: patents typically revolve around concentration, sugar type, isotonicity, and sterility strategy.
- Dexmedetomidine container closure and sterilization: steam and aseptic sterilization approaches show up as claim elements, so competitor process patents or formulation patents likely target those same manufacturing steps.
Key Takeaways
- US 9,717,796 protects a premixed, ready-to-use sterile dexmedetomidine + sugar solution in a plastic container substantially free of DEHP (Claim 1).
- The formulation center of gravity is dexmedetomidine ~4 to 6 μg/mL, with anchors at ~4.0 μg/mL and ~4.7 μg/mL (HCl), plus an isotonic constraint spanning ~4 to 7 μg/mL.
- The strongest composition lock is “consists essentially of dexmedetomidine, dextrose and water” (Claim 4), with additional quantitative support dextrose ~50 mg/mL (Claim 11).
- Packaging scope deepens via dependent claims to specific inner-layer polymer systems: EVA and ethylene-propylene/SEBS, and via container type (ampule/vial/syringe) and flexibility.
- Manufacturing scope deepens via dependent claims to moist steam sterilization and aseptic sterilization.
FAQs
1) What is the single broadest limitation in this patent’s claims?
“Plastic container substantially free of DEHP” in Claim 1.
2) What dexmedetomidine concentration range is repeatedly targeted?
Claims cluster around about 4 to 6 μg/mL, expanded to about 4 to 7 μg/mL when isotonic (Claim 14).
3) Does the patent require dextrose specifically?
Not in Claim 1, but Claim 4 does. Claim 4 locks the composition to dexmedetomidine, dextrose, and water “consists essentially of.”
4) Are specific container polymers claimed?
Yes. Dependent claims specify inner layers of ethylene-vinyl acetate copolymer (Claim 6) and ethylene-propylene with SEBS (Claim 13).
5) What sterilization methods are recited?
Dependent claims include moist steam sterilization (Claim 7) and aseptic sterilization (Claim 9).
References
- User-provided: United States Drug Patent 9,717,796 claim text (Claims 1-16).
