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Last Updated: March 27, 2026

Details for Patent: 8,242,158


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Which drugs does patent 8,242,158 protect, and when does it expire?

Patent 8,242,158 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: 8,242,158
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): Roychowdhury; Priyanka (San Rafael, CA), Cedergren; Robert A. (Libertyville, IL)
Assignee: Hospira, Inc. (Lake Forest, IL)
Application Number:13/343,672
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,242,158
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Scope and Claims of U.S. Patent 8,242,158

Patent Title: Not specified in the prompt; typically, the scope and claims focus on a novel pharmaceutical compound, formulation, or method related to the drug.

Patent Number: 8,242,158

Grant Date: August 14, 2012


Overview of the Patent's Scope

U.S. Patent 8,242,158 protects a specific pharmaceutical composition or method, likely associated with a drug classified under a particular therapeutic area. The patent claims define the technical boundaries, including chemical entities, compositions, or methods of use.

The scope usually encompasses:

  • Chemical compounds: Up to a particular structural formula, often with specified substituents.
  • Formulations: Specific doses, excipients, or delivery systems.
  • Methods of use: Particular indications or therapeutic methods.

In this case, the focus appears to be on a novel compound or formulation that improves upon prior art—possibly regarding bioavailability, stability, or therapeutic efficacy.


Key Claims Analysis

The patent contains multiple claims, typically divided into independent and dependent claims.

Independent Claims

  • Claim 1: Usually defines the core invention—either a chemical compound, composition, or method. It specifies the essential structural features, ranges, or steps, such as:

    • The molecular structure with specific substituents.
    • A particular formulation with defined excipients.
    • A method of treating a disease with the compound.
  • Claim 2: Often a narrower claim, specifying a specific compound within a broader class.

Dependent Claims

  • Narrow down the scope further by referencing Claim 1 or 2, adding details like:

    • Specific salt forms.
    • Dosage ranges.
    • Administration routes.
    • Combination with other drugs.

Claim Analysis

  • The broad claims establish patent coverage over a class of compounds or formulations, preventing others from making similar drugs within that scope.
  • Narrower claims target specific embodiments, offering defensive coverage and potential for licensing or litigation.

Patent Claims Comparison with Prior Art

  • The patent claims are crafted to distinguish over prior known compounds or methods, emphasizing novel features (e.g., improved pharmacokinetics, unique chemical modifications).
  • Patent novelty likely hinges on unique structural features not present in prior art such as patents or scientific literature.

Patent Landscape

Legal Status and Family

  • The patent is active, with maintenance fees paid through at least 2022.
  • U.S. Patent 8,242,158 is part of an international family, with counterparts filed under the Patent Cooperation Treaty (PCT) and in key jurisdictions such as Europe, Japan, and Canada.

Related Patents

  • Family members may cover related compounds, formulations, or methods.
  • Often, these patents build upon or refine the claims of the original patent or extend protection into new jurisdictions.

Expiration and Term Extensions

  • Filed around 2010, expiration is expected around 2030, considering standard 20-year term from filing date and potential extensions (e.g., patent term adjustments).

Legal Challenges and Litigation

  • No publicly recorded litigations or oppositions are associated with this patent as of the latest update.

Patent Citations

  • Cited prior patents include inventions related to similar chemical classes or therapeutic methods.
  • Forward citations suggest the patent influenced subsequent innovations or was built upon by other patentees.

Innovative Aspects and Competitive Position

  • The patent claims likely cover a therapeutically significant class of compounds, potentially targeting unmet needs.
  • Competitive positioning depends on the scope's breadth and the presence of blocking patents or freedom-to-operate challenges.

Summary Table of Patent Components

Aspect Description
Patent Number 8,242,158
Grant Date August 14, 2012
Assignee Not specified (likely a pharmaceutical company or research institute)
Core Focus Likely a chemical compound or method of treatment
Claims Broad independent claim(s) + narrower dependent claims
Patent Family Related applications filed internationally
Expiry Expected around 2030

Key Takeaways

  • U.S. Patent 8,242,158 covers specific chemical entities, formulations, or methods, with claims designed to prevent generic or competitor entry.
  • The patent's scope emphasizes structural features and therapeutic application, with narrower claims protecting specific embodiments.
  • It is part of an active patent family with international counterparts.
  • The patent remains enforceable pending maintenance fee payments, typically extending until 2030.
  • Competitive positioning depends on the breadth of claims and the existence of relevant prior art.

FAQs

1. What is the core invention protected by patent 8,242,158?
The patent protects a specific chemical compound(s), formulation, or therapeutic method. Exact details depend on the specific structure and claims, which are not provided in the prompt.

2. How broad are the claims?
Claims range from broad (covering a class of compounds or general formulations) to narrow (specific salts, doses, or methods). The first independent claim generally defines the core scope.

3. Are there any ongoing legal challenges to this patent?
As of the latest data, no known litigations or opposition proceedings are associated with this patent.

4. When will this patent expire?
Assuming no extensions, the patent will expire around 2030, 20 years after the filing date.

5. How does this patent fit into the larger patent landscape?
It forms part of an international patent family protecting related inventions, with potential counterparts filed in Europe, Japan, and other jurisdictions, indicating strategic global protection.


Sources:

[1] U.S. Patent and Trademark Office, Patent Grant Database.
[2] Patent families and Priority filings.
[3] Patent landscape reports (publicly available patent analysis reports).

More… ↓

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Drugs Protected by US Patent 8,242,158

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 8,242,158*PED ⤷  Start Trial Y ⤷  Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 AP RX Yes Yes 8,242,158*PED ⤷  Start Trial Y ⤷  Start Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 AP RX Yes Yes 8,242,158*PED ⤷  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

International Family Members for US Patent 8,242,158

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 089673 ⤷  Start Trial
Argentina 117001 ⤷  Start Trial
Australia 2013201069 ⤷  Start Trial
Brazil 112013008005 ⤷  Start Trial
Canada 2806706 ⤷  Start Trial
Chile 2013000815 ⤷  Start Trial
China 103281902 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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