Details for Patent: 9,616,049

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Which drugs does patent 9,616,049 protect, and when does it expire?

Patent 9,616,049 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-one patent family members in thirty-five countries.

Summary for Patent: 9,616,049

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:	US15/058,602
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,616,049
Patent Claim Types: see list of patent claims	Composition; Dosage form;

US Patent 9,616,049: Dexmedetomidine Ready-to-Use Injection Claims, Patent Scope, and Competitive Landscape

US Patent 9,616,049 protects a ready-to-use, parenteral dexmedetomidine liquid in a sealed glass container. The broadest claim covers dexmedetomidine concentrations from approximately 0.005 to 50 micrograms per milliliter and a pH from approximately 2 to 10. Dependent claims narrow the composition toward the commercial premixed presentation: dexmedetomidine hydrochloride at approximately 4 micrograms per milliliter, with 0.9% sodium chloride, in a 20 mL, 50 mL, or 100 mL container, terminally sterilized by autoclave.

The patent is commercially relevant to ready-to-use dexmedetomidine products, particularly premixed products that compete with Hospira/Pfizer’s Precedex presentations. It is less relevant to conventional concentrated dexmedetomidine vials that require dilution before administration.

What does US Patent 9,616,049 protect?

The patent claims a combination of five technical elements:

1. Dexmedetomidine or a pharmaceutically acceptable salt.
2. A liquid composition intended for parenteral administration.
3. A specified dexmedetomidine concentration.
4. A pH within the claimed range.
5. Storage in a sealed glass container.

Claim 1 is the principal composition claim:

Claim element	Scope of claim 1
Active ingredient	Dexmedetomidine or a pharmaceutically acceptable salt
Dosage form	Ready-to-use liquid
Route	Parenteral administration
Concentration	Approximately 0.005 to 50 micrograms/mL
Container	Sealed glass container
pH	Approximately 2 to 10

The claim is drafted as a product claim. It does not require a particular clinical indication, infusion rate, administration device, or patient population. A product may fall within the claim regardless of whether it is used for intensive-care sedation, procedural sedation, or another approved parenteral use, provided the claimed composition and container limitations are present.

The “ready-to-use” limitation is significant. A concentrated vial intended for dilution before administration may not satisfy that limitation, even if it contains dexmedetomidine within the claimed concentration range after dilution. A premixed bag or vial that can be administered without dilution presents a substantially stronger infringement risk.

How do claims 1 through 14 differ?

Claims 2 through 14 create nested fall-back positions. They do not materially broaden the patent beyond claim 1.

Claim	Additional limitation	Commercial significance
1	0.005-50 micrograms/mL; pH 2-10; sealed glass	Broadest independent composition claim
2	pH 4-8	Captures physiologically moderate formulations
3	pH 4.5-8	Narrows pH range
4	pH 4.5-7	Narrower stability and tolerability range
5	0.05-15 micrograms/mL	Removes extreme concentrations
6	0.5-10 micrograms/mL	Covers typical injectable concentrations
7	1-7 micrograms/mL	Encompasses the commercial 4 microgram/mL strength
8	Approximately 4 micrograms/mL	Directly targets a common premixed presentation
9	0.01-2.0 weight percent sodium chloride	Claims isotonic or near-isotonic formulations
10	Approximately 0.9 weight percent sodium chloride	Covers standard normal-saline formulation
11	20, 50, or 100 mL total volume	Covers common vial or small-bag configurations
12	Dexmedetomidine hydrochloride	Targets the standard pharmaceutical salt
13	Terminal sterilization	Adds a manufacturing condition
14	Autoclave sterilization	Narrowest identified manufacturing claim

The practical infringement center of gravity is claims 7 through 14. A product containing approximately 4 micrograms/mL dexmedetomidine hydrochloride in 0.9% sodium chloride, supplied in a sealed glass container and terminally sterilized, may satisfy multiple claims simultaneously.

What formulations are protected by US 9,616,049?

The patent protects formulations that combine dexmedetomidine with a liquid parenteral vehicle and the specified container and pH characteristics.

Formulations likely within the claim scope

Examples that may fall within the claims include:

• Dexmedetomidine hydrochloride at 4 micrograms/mL in 0.9% sodium chloride.
• A ready-to-use dexmedetomidine solution at 1-7 micrograms/mL and pH 4.5-7.
• A 20 mL or 50 mL sterile glass vial containing premixed dexmedetomidine injection.
• A 100 mL ready-to-use glass container containing dexmedetomidine in isotonic saline.
• A formulation terminally sterilized by autoclave.

The claim does not expressly require sodium chloride, isotonicity, a preservative, a buffer, or a specific excipient. Those features appear only in dependent claims or may be unnecessary for infringement of claim 1.

Formulations with lower apparent risk

The following design choices may reduce literal infringement risk, although they require claim-by-claim analysis:

• A non-glass container, such as a polymer bag or polymer syringe.
• A concentrated product that requires dilution before use.
• A formulation outside the claimed pH or concentration ranges.
• A container volume other than 20, 50, or 100 mL, for avoiding claim 11.
• A product that is not terminally sterilized, for avoiding claims 13 and 14.
• A product using a dexmedetomidine formulation that does not satisfy the “ready-to-use” limitation.

Avoiding a dependent claim does not avoid claim 1. For example, a 250 mL polymer bag may avoid claims 11 and possibly claim 1’s glass-container limitation, but a 50 mL glass vial at a different pH may still fall within claim 1.

How strong is the patent estate for dexmedetomidine ready-to-use products?

The patent has a focused but commercially meaningful scope. Its principal strength is the combination of formulation and packaging limitations.

Strengths

The estate is strongest where a competitor’s product matches the following profile:

• Ready-to-use parenteral liquid.
• Dexmedetomidine hydrochloride.
• Approximately 4 micrograms/mL.
• pH between 4.5 and 7.
• 0.9% sodium chloride.
• Sealed glass vial or container.
• Terminal sterilization by autoclave.

These limitations are commercially aligned with a standard premixed injectable product rather than an experimental formulation.

The glass-container limitation can also make infringement analysis more concrete. Regulatory filings, container-closure descriptions, stability protocols, and Chemistry, Manufacturing, and Controls information may reveal the relevant container material and sterilization process.

Limitations

The patent does not claim dexmedetomidine as a molecule. It does not broadly claim every dexmedetomidine injection, every sedation method, or every manufacturing process. It also does not necessarily cover:

• Concentrated dexmedetomidine products requiring dilution.
• Products supplied in non-glass containers.
• Formulations outside the stated concentration and pH ranges.
• Alternative delivery systems that are not ready-to-use liquids.
• Oral, transdermal, intranasal, or other non-parenteral products.

The specification and prosecution history remain important. Terms such as “ready to use,” “sealed glass container,” “about,” and “terminally sterilized” may be litigated based on the intrinsic record and the accused product’s regulatory description.

When does US Patent 9,616,049 lose exclusivity?

US Patent 9,616,049 issued on April 11, 2017. Its term is generally calculated from the earliest effective nonprovisional filing date under the Uruguay Round Agreements Act, subject to patent-term adjustment, terminal disclaimers, and any applicable patent-term extension. Public patent records associate the family with a 2012 filing timeframe, producing an estimated statutory expiration in November 2032, before any patent-term adjustment.

The precise enforceable expiration should be taken from the current USPTO patent record and any terminal-disclaimer or patent-term-adjustment data. The patent does not receive a new 20-year term from its issuance date.

Milestone	Date or status
US patent number	9,616,049
Issue date	April 11, 2017
Subject matter	Ready-to-use dexmedetomidine liquid composition
Expected term basis	Earliest effective nonprovisional filing
Estimated base expiration	November 2032, subject to adjustment
Regulatory relevance	Premixed dexmedetomidine injection products
Small-molecule exclusivity	Separate from patent term

FDA regulatory exclusivity and patent protection are separate. An approved drug may lose FDA market exclusivity before the patent expires, while the patent may continue to restrict a formulation or product presentation.

What is the Orange Book status of US 9,616,049?

US Patent 9,616,049 has been associated with the Precedex product family and is relevant to the Orange Book analysis for dexmedetomidine injection products. The FDA Orange Book determines the operative listed patent and use-code information for approved drug products. A patent’s commercial significance depends on the specific NDA, dosage form, strength, and use code to which it is listed.

An Orange Book-listed formulation patent can create a regulatory obstacle for an ANDA applicant. Under the Hatch-Waxman framework, an ANDA applicant generally must provide a patent certification for each listed patent. A Paragraph IV certification states that the patent is invalid, unenforceable, or will not be infringed by the proposed product. The NDA holder may file suit within the statutory period, potentially triggering a 30-month stay of ANDA approval under 21 U.S.C. § 355(j)(5)(B)(iii).

The listing should be evaluated against:

• The exact Precedex dosage form.
• Whether the product is a ready-to-use solution or concentrate.
• The container presentation.
• The listed patent-use code.
• Any delisting, expiration, or regulatory updates.

Which products and companies are most exposed?

The principal exposure is for companies developing premixed dexmedetomidine injection products that resemble the commercial presentation.

Product strategy	Exposure to US 9,616,049
Concentrated dexmedetomidine vial requiring dilution	Lower formulation exposure
Ready-to-use glass vial at 4 micrograms/mL	High exposure
Ready-to-use polymer bag at 4 micrograms/mL	Potentially reduced glass-container exposure
0.9% sodium chloride formulation in glass	High exposure, including dependent claims
Alternative pH formulation outside claim ranges	Potentially reduced exposure
Ready-to-use product in 20, 50, or 100 mL glass container	High exposure
Non-terminally sterilized product	May avoid claims 13 and 14 but not necessarily claim 1
Hospital-compounded dexmedetomidine	Regulatory and patent analysis depends on the product and statutory exemption

Hospira is the historical patent holder and commercial sponsor associated with the product family. Pfizer acquired Hospira in 2015, making Pfizer the relevant corporate successor for Hospira’s pharmaceutical portfolio. Generic and injectable-product companies with dexmedetomidine programs may face different exposure depending on whether they pursue an abbreviated application for a concentrate, a premixed injection, or a differentiated presentation.

What Paragraph IV challenges and litigation risks exist?

A generic applicant challenging an Orange Book-listed patent could use a Paragraph IV certification based on:

• Noninfringement of the ready-to-use limitation.
• Noninfringement of the sealed-glass-container limitation.
• Noninfringement based on concentration or pH.
• Invalidity for anticipation.
• Invalidity for obviousness.
• Lack of written description or enablement.
• Indefiniteness of terms such as “about” or “ready to use.”
• Patent-term or listing defects, where applicable.

The most credible noninfringement position would usually involve a materially different dosage form or container, such as a concentrated vial requiring dilution or a polymer-based presentation. An invalidity challenge would likely focus on prior art disclosing stable dexmedetomidine solutions, parenteral administration, concentrations near 4 micrograms/mL, normal saline vehicles, glass containers, and terminal sterilization.

The patent’s dependent claims create litigation fall-back positions. Even if a challenger defeats claim 8’s approximately 4 microgram/mL limitation, claims 1, 5, 6, or 7 may remain relevant if the accused product is within their broader ranges. Conversely, a non-glass product may remove the central limitation shared by all claims.

No settlement agreement, final judgment, or currently operative Paragraph IV litigation outcome should be inferred solely from the patent claims. Litigation status must be confirmed through PACER, FDA correspondence, and the Orange Book.

How does this patent compare with earlier dexmedetomidine patents?

Earlier dexmedetomidine patents generally addressed the active compound, pharmaceutical use, or sedation methods. US 9,616,049 is different because it focuses on the finished injectable presentation.

Patent category	Typical subject matter	Relevance to ready-to-use products
Compound patents	Dexmedetomidine molecule or stereochemistry	Generally expired or historical
Method-of-use patents	Sedation, intensive-care use, procedural applications	Depends on the label and proposed indication
Concentrate formulation patents	Injectable dexmedetomidine requiring dilution	Relevant to vial products
Premixed formulation patents	Ready-to-use liquid, container, pH, concentration	Direct relevance
Manufacturing patents	Sterilization, filling, stability, container closure	May create separate process risk
Device patents	Infusion pumps or administration systems	Product-specific

The main commercial distinction is between a concentrated injectable and a premixed product. A generic applicant can reduce exposure by following a conventional concentrate pathway, but that strategy may not compete directly with ready-to-use premixed products.

What manufacturing and IP barriers affect generic launch?

The patent is not the only barrier. A commercially viable competing product must also address:

• Sterility assurance.
• Container-closure integrity.
• Dexmedetomidine stability over shelf life.
• Adsorption or interaction with glass and elastomer components.
• Particulate and extractables requirements.
• Terminal sterilization validation.
• Compatibility with infusion systems.
• Labeling and administration instructions.
• ANDA sameness requirements.
• Commercial availability of the chosen container.

A non-glass container may reduce patent risk but introduce a different technical profile. Polymer materials can affect permeability, extractables, adsorption, and stability. A formulation outside the pH range may require a different buffer system and may create tolerability or stability issues.

The claim to autoclave sterilization is narrower than the broader composition claims. A manufacturer that uses aseptic processing instead of terminal sterilization may avoid claims 13 and 14, but the product could still infringe claim 1 if it remains a ready-to-use dexmedetomidine liquid in a sealed glass container within the claimed concentration and pH ranges.

What generic launch scenarios are most plausible?

Scenario 1: Concentrate-first launch

A company launches a concentrated dexmedetomidine injection that requires dilution. This approach may avoid the principal ready-to-use limitation and reduce exposure to US 9,616,049. It competes with conventional dexmedetomidine injection rather than directly duplicating the premixed presentation.

Scenario 2: Polymer premix

A company develops a ready-to-use product in a polymer bag or syringe. This may avoid the sealed-glass-container limitation, but it remains exposed to other formulation patents, regulatory requirements, and potential doctrine-of-equivalents arguments.

Scenario 3: Glass premix with Paragraph IV challenge

A company files an ANDA for a glass-container premix and challenges US 9,616,049. This offers the closest product substitution but creates the highest litigation exposure.

Scenario 4: Delayed launch after patent expiry

A company files early and launches after the patent expires, subject to any patent-term adjustment, litigation settlement, other listed patents, pediatric exclusivity, or regulatory exclusivity.

Key Takeaways

• US 9,616,049 is a formulation-and-container patent, not a basic compound patent.
• Claim 1 broadly covers a ready-to-use parenteral dexmedetomidine liquid in a sealed glass container at approximately 0.005-50 micrograms/mL and pH 2-10.
• Claims 7-14 focus on the commercially important configuration of approximately 4 micrograms/mL dexmedetomidine hydrochloride in 0.9% sodium chloride and glass containers.
• Concentrated vials requiring dilution present lower direct exposure than premixed products.
• Polymer presentations may provide a design-around path for the glass-container limitation.
• The estimated base patent expiration is in November 2032, subject to patent-term adjustment and other statutory factors.
• Orange Book listing, NDA linkage, use codes, and current USPTO status control the regulatory and litigation analysis.
• A Paragraph IV strategy would likely focus on ready-to-use, glass-container, concentration, pH, and validity issues.
• Manufacturing choices, particularly terminal sterilization and container selection, can materially change the infringement profile.

FAQs

Does US 9,616,049 cover all dexmedetomidine injections?

No. It targets ready-to-use liquid parenteral compositions in sealed glass containers. Concentrated vials requiring dilution and non-glass presentations may fall outside the principal claim.

Does a product with 4 micrograms/mL dexmedetomidine automatically infringe?

No. Concentration alone is insufficient. The product must also satisfy the relevant dosage-form, parenteral, pH, ready-to-use, and sealed-glass-container limitations.

Can a manufacturer avoid claims 13 and 14 through aseptic filling?

Potentially. Aseptically processed product may avoid the terminal-sterilization and autoclave limitations, but it can still fall within claim 1 or other composition claims.

Does using dexmedetomidine free base avoid the patent?

Not necessarily. Claim 1 covers dexmedetomidine and pharmaceutically acceptable salts. Claim 12 specifically identifies the hydrochloride salt, but avoiding claim 12 does not avoid claim 1.

Is a 250 mL glass container outside the volume claim?

It may be outside claim 11, which specifies 20 mL, 50 mL, or 100 mL. It may still fall within claim 1 because claim 1 does not impose a volume limitation.

References

1. U.S. Patent No. 9,616,049. (2017). Dexmedetomidine pharmaceutical compositions. U.S. Patent and Trademark Office.

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: The Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

3. U.S. Food and Drug Administration. (n.d.). Precedex (dexmedetomidine hydrochloride) prescribing information. Pfizer Laboratories.

4. United States Code, 21 U.S.C. § 355. (2024). New drugs and antibiotic drugs.

5. United States Patent and Trademark Office. (n.d.). Patent term adjustment and patent term extension. https://www.uspto.gov/patents/laws/patent-term-adjustment-patent-term-extension-recovery-methods/patent-term-calculator

Drugs Protected by US Patent 9,616,049

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	9,616,049*PED				Y
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-002	Mar 13, 2013	AP	RX	Yes	Yes	9,616,049*PED				Y
Hospira	PRECEDEX	dexmedetomidine hydrochloride	INJECTABLE;INJECTION	021038-003	Mar 13, 2013	AP	RX	Yes	Yes	9,616,049*PED				Y

International Family Members for US Patent 9,616,049

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	089673
Argentina	117001
Australia	2013201069
Brazil	112013008005
Canada	2806706