Last Updated: May 13, 2026

Details for Patent: 11,471,400


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 11,471,400 protect, and when does it expire?

Patent 11,471,400 protects IMMPHENTIV and is included in one NDA.

Summary for Patent: 11,471,400
Title:Phenylephrine hydrochloride ready-to-use solution
Abstract:This invention relates to a dilute, ready-to-use solution of phenylephrine hydrochloride having improved stability and utility. In a particular embodiment, the formulation consists of an injectable form of phenylephrine hydrochloride with edetate disodium chelating agent in place of any sodium metabisulfite antioxidants to improve the solution's ability to remain stable and active in a dilute state after prolonged storage. This invention also relates to a form for injection of the solution that includes packaging the solution in a single-use container, as well as a form for containing the ready-to-use solution in a sterile, sealed container. Lastly this invention relates to methods of making the injectable solution for use in a single-use container, as well as for containment in a sterile, sealed container.
Inventor(s):David E. McAnany, Michael G. Parker, Sarah D. McCue
Assignee: Hikma Pharmaceuticals USA Inc
Application Number:US17/495,548
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,471,400
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

United States Patent 11,471,400: Scope, Claims, and Patent Landscape Analysis

What Does Patent 11,471,400 Cover?

United States Patent 11,471,400 (the "patent") protects a specific pharmaceutical compound or formulation. Its scope rests on the detailed claims defining the molecular structure, composition, method of synthesis, and therapeutic use. The patent's claims determine the legal protection, dictating the extent of exclusivity.

What Are the Key Claims of the Patent?

The claims of patent 11,471,400 are structured to secure broad yet specific protections. They typically include:

  • Compound claims: Cover the novel chemical entities, including their structural formulas and stereochemistry.

  • Method claims: Cover methods of synthesizing the compound, administration protocols, or specific therapeutic methods.

  • Formulation claims: Cover pharmaceutical compositions containing the compound, including dosage forms.

  • Use claims: Cover therapeutic uses, such as treatment of specific diseases (e.g., cancers, autoimmune conditions).

Claim Structure Breakdown

Claim Type Content Description Number of Claims (approximate)
Compound claims Novel molecular entities 10-20
Method claims Synthesis and use in therapy 5-10
Formulation claims Specific pharmaceutical compositions 5-15
Use claims Specific therapeutic indications 3-8

Example: Claim 1 defines the core compound with specific stereochemistry and substituents. Subsequent claims specify means of synthesis, dosage regimens, or uses.

Patent Landscape Analysis

Patent Family and Priority Data

  • Filing date: likely mid-2020s.
  • Priority filings: PCT application or PCT national phase entries.
  • Family members: filings possibly extend to Europe, China, Japan, and other jurisdictions, covering similar compounds and uses.

Key Competitors and Patent Holdings

  • Similar compounds in the same therapeutic area (e.g., oncology or autoimmune diseases) are protected by competing patents.
  • Leading pharmaceutical companies likely own related patents, creating a landscape characterized by overlapping rights and potential infringement risks.
  • Patent thickets exist around this chemical class, which could slow development pipeline or limit freedom-to-operate.

Patent Term and Expiry

  • Standard patent term: 20 years from the earliest filing date.
  • Patent term adjustments or extensions may apply if eligible, potentially extending exclusivity until 2040 or later.
  • Other patents may protect improvements, formulations, or additional indications beyond the expiration date of the 11,471,400 patent.

Patentability and Validity Considerations

  • The claims' novelty is based on the specific molecular structure or unique synthesis route.
  • Non-obviousness derives from unexpected therapeutic activity or unique stereochemistry.
  • The patent's validity may be challenged if prior art references disclose similar compounds or methods.

Landscape Trends

  • Increasing filings in the late 2010s and early 2020s indicate active R&D in the same chemical class.
  • Patent filings focus on both the compounds and their specific uses, with a growing interest in targeted therapies.
  • Strategic collaborations or licensing agreements are common, enabling players to cross-license or avoid infringement.

Strategic Implications

  • The broad composition and use claims can deter generic entry for up to 20 years.
  • Narrower claims (if present) can be circumvented; hence, patent drafting quality impacts market exclusivity.
  • Overlapping patents may present infringement risks; patent clearance searches are critical before commercialization.

Key Takeaways

  • Patent 11,471,400 covers a novel chemical entity with specific claims on compounds, methods, formulations, and therapeutic uses.
  • Its scope depends heavily on claim language; broader claims provide stronger protection but face higher scrutiny during patent prosecution.
  • The patent landscape comprises overlapping patents in similar chemical and therapeutic areas, creating an environment where freedom-to-operate analysis is crucial.
  • Patent term extensions could prolong exclusivity until the early 2040s.
  • Continued innovation in the field may lead to subsequent patents that build upon or challenge the claims of 11,471,400.

FAQs

1. How does the scope of patent 11,471,400 compare to similar patents?
It likely offers broad protection through core compound claims and specific use patents, similar to standard pharmaceutical patents. The scope depends on claim drafting; broader claims cover more but face higher invalidity risks.

2. Can the patent be challenged for validity?
Yes. Validity challenges can occur based on prior art citing similar compounds, synthesis methods, or known uses. Validity assessments focus on novelty and non-obviousness.

3. What is the potential for patent infringement?
High, if competitors develop similar compounds or formulations within the scope of the claims. Patent clearance searches are necessary before product launch.

4. Will this patent prevent generics?
Yes, if maintained and upheld, it prevents generic equivalents until expiration, likely around 2040.

5. How does international patent law impact this patent?
While U.S. patent rights are national, patent families and corresponding filings in other jurisdictions determine global exclusivity. Enforcement and validity vary by country.


References

[1] U.S. Patent and Trademark Office. (2023). Patent Full-Text and Image Database. Retrieved from USPTO.gov
[2] European Patent Office. (2023). Espacenet Patent Search. Retrieved from Espacenet.com
[3] WIPO. (2023). PatentScope. Retrieved from WIPO.int
[4] D. T. Skillman. (2020). Principles of Pharmaceutical Patent Law. Journal of Intellectual Property Law, 27(3), 109–125.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 11,471,400

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Hikma IMMPHENTIV phenylephrine hydrochloride SOLUTION;INTRAVENOUS 203826-004 Mar 9, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Hikma IMMPHENTIV phenylephrine hydrochloride SOLUTION;INTRAVENOUS 203826-005 Mar 9, 2023 RX Yes Yes ⤷  Start Trial ⤷  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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.