Details for Patent: 9,320,712

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Which drugs does patent 9,320,712 protect, and when does it expire?

Patent 9,320,712 protects PRECEDEX and is included in one NDA.

Protection for PRECEDEX has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty-three patent family members in thirty-six countries.

Summary for Patent: 9,320,712

Title:	Dexmedetomidine premix formulation
Abstract:	The presently disclosed subject matter relates to pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically acceptable salt thereof wherein the composition is formulated as a liquid for parenteral administration to a subject, and wherein the composition is disposed within a sealed container as a premixture. The pharmaceutical compositions can be used, for example, in perioperative care of a patient or for sedation.
Inventor(s):	Priyanka Roychowdhury, Robert A. Cedergren
Assignee:	Hospira Inc
Application Number:	US14/177,008
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,320,712
Patent Claim Types: see list of patent claims	Composition; Dosage form;

US Patent 9,320,712: Dexmedetomidine Ready-to-Use Injection Claims and Patent Landscape

US Patent 9,320,712 protects a ready-to-use parenteral dexmedetomidine hydrochloride solution in a sealed glass container. The independent claim covers a broad concentration range of approximately 0.005 to 50 micrograms per milliliter. The dependent claims narrow the formulation to clinically relevant concentrations, particularly 4 micrograms per milliliter, with optional sodium chloride and specified container volumes.

The patent is directed to a finished injectable product, not dexmedetomidine as an active pharmaceutical ingredient. Its commercial significance is greatest for premixed dexmedetomidine injection products, especially 4 mcg/mL products supplied in 20 mL, 50 mL, or 100 mL sealed glass containers.

What does US Patent 9,320,712 protect?

The patent protects a composition that satisfies all of the following claim 1 elements:

Claim limitation	Scope
Pharmaceutical composition	A drug product, rather than a process or isolated compound
Ready-to-use liquid	A liquid that can be administered without reconstitution or dilution
Parenteral administration	Administration by injection or infusion
Dexmedetomidine	The active ingredient
Concentration	Approximately 0.005 to 50 mcg/mL
Container	A sealed glass container
Chemical form	Dexmedetomidine hydrochloride

The claim does not require sodium chloride, a particular pH, a particular volume, or a specific administration route such as intravenous infusion. Those limitations appear only in dependent claims or in the broader specification.

The use of “about” expands the practical boundaries of the concentration limitations. The scope would depend on ordinary pharmaceutical measurement tolerances, claim construction, prosecution history, and the accused product’s actual labeled and measured concentration.

What is the independent claim scope?

Claim 1 is composition-based. It does not require:

• A specific manufacturing process;
• A particular infusion pump;
• A specific clinical indication;
• A specific dose;
• A specified pH;
• A specified excipient other than dexmedetomidine hydrochloride;
• A specified volume;
• A particular glass type.

The claim can therefore reach a broad range of premixed dexmedetomidine hydrochloride injections if the product is supplied as a liquid in a sealed glass container and falls within the claimed concentration range.

A product in a plastic bag may avoid literal infringement of the “sealed glass container” limitation, although the result would depend on the product configuration, packaging components, labeling, and possible doctrine-of-equivalents arguments.

How do claims 2 through 8 narrow the patent?

Claims 2 through 8 create progressively narrower commercial embodiments.

Claim	Limitation	Commercial relevance
1	0.005-50 mcg/mL in sealed glass container	Broadest product claim
2	0.05-15 mcg/mL	Covers most practical premixed concentrations
3	0.5-10 mcg/mL	Captures common injectable strengths
4	1-7 mcg/mL	Includes 4 mcg/mL products
5	About 4 mcg/mL	Directly targets the standard premixed strength
6	Sodium chloride at 0.01-2.0 wt.%	Adds an isotonicity-related formulation limitation
7	About 0.9 wt.% sodium chloride	Covers normal-saline formulations
8	20, 50, or 100 mL total volume	Targets commercial package sizes

Claim 5 is the most commercially focused concentration claim. Claim 7 is important for a formulation containing approximately 0.9% sodium chloride. Claim 8 is important because a product can meet the concentration limitations but fall outside claim 8 if it is supplied in another volume.

Claim 8 is dependent on claim 1, not claim 7. A 100 mL product containing 4 mcg/mL dexmedetomidine hydrochloride and no sodium chloride can still fall within claims 1, 4, 5, and 8 if the remaining limitations are satisfied.

What formulations are protected by US 9,320,712?

The patent covers ready-to-use liquid formulations containing dexmedetomidine hydrochloride within the claimed concentration ranges. The strongest commercial overlap is with the following formulation profile:

Product characteristic	Relevant claim
Dexmedetomidine hydrochloride	Claim 1
4 mcg/mL strength	Claim 5
0.9% sodium chloride	Claim 7
100 mL presentation	Claim 8
Sealed glass container	Claim 1
Parenteral administration	Claim 1

A product containing 400 mcg of dexmedetomidine hydrochloride in 100 mL, equivalent to 4 mcg/mL, is within the concentration and volume limitations of claims 5 and 8 if supplied in a sealed glass container.

The claims are not limited to sodium chloride formulations. The presence of sodium chloride creates additional dependent-claim exposure, but its absence does not avoid claim 1 or claims 2 through 5.

Does the patent cover Precedex?

Precedex is dexmedetomidine hydrochloride injection. FDA labeling identifies both concentrated and ready-to-use presentations, including a 4 mcg/mL ready-to-use injection presentation.[1] A Precedex-type product supplied at approximately 4 mcg/mL in a sealed glass container is the clearest commercial embodiment corresponding to claims 1, 4, 5, and potentially 8.

The infringement analysis depends on the actual approved product configuration. A concentration match alone is not sufficient. The container must also satisfy the sealed-glass limitation for literal infringement.

When does US Patent 9,320,712 expire?

The patent has a listed statutory expiration date of approximately May 30, 2033, based on its earliest effective nonprovisional priority date and the 20-year patent-term framework.[2][3]

Event	Date or status
Earliest priority basis	2013
US patent grant	April 26, 2016
Expected patent expiration	May 30, 2033
Patent type	Utility patent
Relevant term adjustment	Must be confirmed in the USPTO term record
Patent-term extension	No extension is identified in the cited public records

The effective blocking period can be shorter than the nominal expiration date if the patent is disclaimed, invalidated, narrowed in litigation, or removed from the FDA Orange Book. Conversely, patent-term adjustment can affect the final enforceable expiration date. The USPTO term information controls the legal expiration calculation.[2]

What is the Orange Book status of US 9,320,712?

US Patent 9,320,712 has been associated with dexmedetomidine hydrochloride injection products in the FDA patent-listing framework. Orange Book relevance is product-specific. The listing does not create patent rights beyond the issued claims, and an Orange Book listing does not establish that every dexmedetomidine product infringes.

For an ANDA applicant, a listed patent can trigger a Paragraph III certification, Paragraph IV certification, or other certification depending on the patent’s expiration, relevance, and the applicant’s product design.[4]

The key Orange Book issue is whether the applicant seeks approval for a ready-to-use presentation that matches the listed product and falls within the issued claims. An ANDA directed only to a different container system, such as a non-glass container, may have a stronger noninfringement position against the container limitation. That position would not necessarily eliminate exposure under other dexmedetomidine patents.

What Paragraph IV challenges affect this patent?

A Paragraph IV challenge would assert that the listed patent is invalid, unenforceable, or not infringed. The most likely noninfringement theories for this patent would focus on:

1. A container that is not glass;
2. A package that is not sealed in the claimed manner;
3. A concentration outside the relevant range;
4. A product that requires dilution or reconstitution and is not “ready to use”;
5. A formulation that does not contain dexmedetomidine hydrochloride;
6. A parenteral product supplied in a different presentation.

A validity challenge could focus on anticipation, obviousness, written description, enablement, indefiniteness, or claim construction. The likely prior-art field includes earlier dexmedetomidine formulations, concentrated injections, ready-to-use parenteral products, isotonic saline systems, and glass-container packaging.

A Paragraph IV certification itself is not proof that an applicant has launched or that the patent is weak. The ANDA applicant’s identity and detailed certification strategy generally are not fully disclosed by the public Orange Book record.[4]

Which companies are challenging US 9,320,712?

Public FDA patent data generally does not identify every ANDA applicant that has submitted a Paragraph IV certification. A reliable public record must be established through Hatch-Waxman litigation filings, FDA litigation correspondence, or a district-court docket.

The principal generic and injectable-drug competitors in the dexmedetomidine market include Fresenius Kabi, Hikma, Sagent Pharmaceuticals, and other ANDA sponsors. Their commercial presence does not, by itself, establish that each company challenged US 9,320,712.

What patent litigation affects dexmedetomidine ready-to-use injections?

Patent disputes involving dexmedetomidine can arise from several patent families:

• Ready-to-use liquid compositions;
• Dexmedetomidine concentration and dilution systems;
• Glass-container formulations;
• Stability and storage systems;
• Methods of sedation and intensive-care use;
• Manufacturing and packaging technologies.

US 9,320,712 is most directly relevant to the finished ready-to-use product. It is less directly relevant to a concentrated vial that must be diluted before administration, unless the accused product independently satisfies the ready-to-use limitation.

A litigation analysis should distinguish between:

Issue	Relevance to US 9,320,712
Product patent infringement	High
Process patent infringement	Low, because the claims are composition claims
Method-of-use infringement	Low for the issued claims
Container configuration	High
Concentration	High
Sodium chloride content	Relevant only to claims 6 and 7
Package volume	Relevant only to claim 8
FDA approval status	Commercially relevant but not dispositive of infringement

No settlement terms should be inferred from FDA approval or market entry alone. Hatch-Waxman settlements may include launch dates, licenses, authorized-generic arrangements, or restrictions that are not apparent from the patent record.

Are there method-of-use patents for dexmedetomidine?

Dexmedetomidine has a broader patent landscape than US 9,320,712. Earlier patents addressed the active ingredient, alpha-2 adrenergic agonist use, sedation, anesthesia, intensive-care treatment, and procedural applications.

The commercial force of method-of-use patents is narrower than a product claim. A method claim generally requires proof that the accused party practiced or induced the claimed method. A ready-to-use composition claim can create more direct product exposure because the product itself is the claimed subject matter.

FDA labeling also matters. If a generic label includes a patented indication, induced-infringement risk can increase. A carve-out or “skinny label” may reduce method-of-use exposure, although it does not necessarily avoid a composition patent covering the product itself.[5]

How strong is the patent estate for dexmedetomidine?

US 9,320,712 has moderate-to-strong commercial relevance but a fact-dependent enforcement profile.

Strengths

• Claim 1 covers a broad concentration range.
• The claim targets a finished, ready-to-use injectable product.
• The 4 mcg/mL limitation in claim 5 aligns with a common commercial presentation.
• The dependent claims address standard package volumes.
• A formulation claim can be easier to assert against a marketed product than a manufacturing-process claim.

Vulnerabilities

• The sealed-glass limitation creates a potential design-around route.
• Earlier dexmedetomidine injection and formulation art may be relevant to obviousness.
• The term “about” can create disputes over concentration boundaries.
• “Ready to use” may require factual analysis of whether dilution or other preparation is necessary.
• The claims do not broadly cover every dexmedetomidine formulation, container, or dosage form.
• A product outside the claimed package volumes may avoid claim 8, although not claim 1.

The strongest infringement case concerns a premixed 4 mcg/mL dexmedetomidine hydrochloride injection supplied in a 100 mL sealed glass container. The weakest case concerns a concentrated product requiring dilution, a plastic-container presentation, or a different active form.

How does US 9,320,712 compare with other dexmedetomidine patents?

Patent category	Typical protected subject matter	Relationship to US 9,320,712
Original compound patents	Dexmedetomidine molecule and salts	Foundational but generally expired or near-expired
Concentrate patents	High-strength injectable dexmedetomidine	May cover vial products rather than premixed solutions
Ready-to-use formulation patents	Premixed liquid composition	Most directly overlapping
Container patents	Glass, polymer, closure, or packaging systems	Can create separate product exposure
Method-of-use patents	Sedation, anesthesia, ICU, or procedural use	Label-dependent
Manufacturing patents	Preparation, sterilization, filling, or stability	Process-specific
US 9,320,712	Ready-to-use dexmedetomidine hydrochloride liquid in sealed glass	Direct product claim for selected presentations

The patent should be analyzed as one layer of a product-specific estate. A design-around that avoids US 9,320,712 may still implicate another formulation, packaging, or method-of-use patent.

What generic launch risks exist for dexmedetomidine?

A generic sponsor faces different risks depending on its presentation.

Generic presentation	Risk under US 9,320,712
4 mcg/mL in 100 mL sealed glass	High
4 mcg/mL in 100 mL plastic bag	Lower under literal container analysis
4 mcg/mL in 50 mL glass	Exposure under claims 1, 4, and 5; potentially claim 8
2 mcg/mL in sealed glass	Exposure under claims 1-4; not claim 5
10 mcg/mL in sealed glass	Potential claim 1 and possibly claim 3 exposure
Concentrated vial requiring dilution	Lower under the ready-to-use limitation
Non-hydrochloride dexmedetomidine salt	Potentially outside claim 1
Product with 0.9% sodium chloride	Adds claims 6 and 7 exposure

The principal design-around options are container substitution, concentration changes, non-ready-to-use presentation, and different formulation architecture. Each option can affect FDA approval, manufacturing cost, stability, compatibility, and hospital purchasing preferences.

What licensing deals and ownership changes affect the patent?

Hospira developed and commercialized key dexmedetomidine injection products. Pfizer completed its acquisition of Hospira in 2015, making Pfizer the relevant corporate successor for Hospira’s pharmaceutical assets, subject to any later assignments or licensing arrangements.[6]

No license terms should be assumed from the corporate acquisition. A patent assignment transfers ownership; it does not necessarily disclose downstream supply agreements, authorized-generic arrangements, or settlement licenses.

For diligence, the relevant ownership chain is:

Entity	Relevance
Hospira, Inc.	Original applicant and commercial developer associated with the patent
Pfizer Inc.	Parent-company successor after Hospira acquisition
Generic ANDA sponsors	Potential licensees, challengers, or non-infringing competitors
FDA	Maintains approval and Orange Book records, not private license terms

Key Takeaways

• US 9,320,712 is a product patent covering ready-to-use parenteral dexmedetomidine hydrochloride liquid in a sealed glass container.
• Claim 1 covers approximately 0.005-50 mcg/mL and does not require sodium chloride or a particular package volume.
• Claim 5 specifically targets approximately 4 mcg/mL, the principal commercial premixed strength.
• Claim 7 targets formulations containing approximately 0.9% sodium chloride.
• Claim 8 covers 20 mL, 50 mL, and 100 mL presentations.
• The expected statutory expiration date is approximately May 30, 2033.
• A 4 mcg/mL, 100 mL sealed-glass product presents the highest direct infringement risk.
• Plastic-container products and concentrated vials requiring dilution offer stronger design-around positions against this patent alone.
• The patent does not cover every dexmedetomidine product and must be assessed with related formulation, packaging, manufacturing, and method-of-use patents.
• Biosimilar analysis is not applicable because dexmedetomidine is a chemically synthesized small molecule. Generic competition proceeds through the ANDA pathway rather than the 351(k) biosimilar pathway.

FAQs About US Patent 9,320,712 and Dexmedetomidine

Does US 9,320,712 cover dexmedetomidine concentrate vials?

Not generally if the vial requires dilution or other preparation before administration. The “ready-to-use liquid” limitation is central to claim 1. A concentrate may still be exposed to separate dexmedetomidine patents.

Can a generic avoid the patent by using a plastic IV bag?

A plastic-container product may avoid literal infringement of the sealed-glass limitation. The full product configuration and any related patents must still be reviewed.

Does 0.9% sodium chloride automatically create infringement?

No. It creates potential exposure under claims 6 and 7 only when the other limitations of claim 1 are also satisfied.

Is a 50 mL dexmedetomidine product covered by claim 8?

Yes, if it is a ready-to-use parenteral dexmedetomidine hydrochloride liquid in a sealed glass container and meets the claim 1 limitations. Claim 8 expressly includes 50 mL.

Does FDA approval establish infringement of US 9,320,712?

No. FDA approval and patent infringement are separate legal determinations. Approval confirms regulatory authorization, not whether the product falls within the issued claims.

References

1. U.S. Food and Drug Administration. (2024). Precedex (dexmedetomidine hydrochloride) injection, prescribing information.
2. United States Patent and Trademark Office. (2016). U.S. Patent No. 9,320,712, ready-to-use liquid pharmaceutical composition comprising dexmedetomidine.
3. United States Patent and Trademark Office. (2024). Patent term adjustment and patent term information records.
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
5. U.S. Food and Drug Administration. (2024). Applications covered by patent certifications and use code provisions.
6. Pfizer Inc. (2015). Pfizer completes acquisition of Hospira.

Drugs Protected by US Patent 9,320,712

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-004	Nov 14, 2014	AP	RX	Yes	Yes	9,320,712*PED				Y
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-002	Mar 13, 2013	AP	RX	Yes	Yes	9,320,712*PED				Y
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-003	Mar 13, 2013	AP	RX	Yes	Yes	9,320,712*PED				Y

International Family Members for US Patent 9,320,712

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	089673
Argentina	117001
Australia	2013201069