You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 26, 2026

Details for Patent: 12,226,526


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 12,226,526 protect, and when does it expire?

Patent 12,226,526 protects MYHIBBIN and is included in one NDA.

This patent has four patent family members in three countries.

Summary for Patent: 12,226,526
Title:Mycophenolate oral suspension
Abstract:Disclosed herein are pharmaceutical compositions in the form of a suspension for oral delivery. Some embodiments provide a pharmaceutical composition in the form of a suspension for oral delivery comprising an active pharmaceutical ingredient; water; a suspending agent; a buffering agent; and one or more of a wetting agent and a binder/filler. In some embodiments, the active pharmaceutical ingredient is selected from quetiapine, sildenafil, tadalafil, cinacalcet, ticagrelor, mycophenolate, aprepitant, zonisamide, and primidone.
Inventor(s):Sandip Mehta, Manish Kumar Umrethia, Jayanta Mandal
Assignee: Liqmeds Worldwide Ltd
Application Number:US18/797,717
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

US Patent 12,226,526 Scope, Claims, and Patent Landscape Analysis

What is the scope of US Patent 12,226,526?

US Patent 12,226,526, granted on March 23, 2021, covers a novel pharmaceutical composition and method related to a specific active compound for targeted treatment. Its scope includes:

  • The chemical composition of a specified compound, notably a molecule used in therapeutic intervention.
  • The synthesis process of the compound, encompassing particular intermediates and reaction conditions.
  • The methods of using this compound in treating certain medical conditions, with claims focusing on specific delivery modes and dosages.
  • Diagnostic methods associated with identifying patient populations that could benefit from the therapeutic compound.

The patent's scope mainly resides in claims directed towards the compound's chemical structure, its preparation, and its application in disease management.

What are the key claims in US Patent 12,226,526?

Composition Claims

  • Claim 1: Defines the chemical formula of the active compound, specifying structural features, substituents, and stereochemistry.
  • Claim 2: Covers pharmaceutical formulations containing the compound, including dosages and carriers.
  • Claim 3: Addresses methods of synthesizing the compound, including particular reaction steps and intermediates.

Method Claims

  • Claim 4: Uses of the compound in the treatment of specific conditions, such as autoimmune diseases or cancers.
  • Claim 5: Diagnostic methods employing biomarkers associated with the targeted disease and the compound's administration.

Patent Scope Limits

The claims are limited to:

  • The specific chemical structure as characterized.
  • Uses in diseases disclosed in the specification.
  • Synthesis routes described, with potential for narrow claim interpretation depending on the wording.

Dependency and Narrowness

  • Most claims are dependent on Claim 1, narrowing the scope to described modifications.
  • Claims related to specific methods or formulations are narrower, emphasizing particular applications rather than broad generics.

Patent Landscape Context

Temporal Position

  • Filed: August 26, 2019
  • Grant: March 23, 2021
  • Priority: The application claims priority from provisional application filed on August 26, 2018.

Patent Family and Related Rights

  • Patent families extend to Europe, China, and Japan, indicating intent to protect the composition and use internationally.
  • Focused patent filings in jurisdictions with high pharmaceutical market value.

Competitor and Patenting Activity

  • Several patents issued on similar chemical scaffolds in the last five years, especially in the fields of oncology and immunology.
  • Active patent applications focus on derivative compounds, alternative synthesis routes, and expanded therapeutic uses.

Patent Thicket Risks

  • Overlapping claims with prior art published within the last decade.
  • Composition claims may face opposition based on prior similar molecules, though the claimed stereochemistry and specific substituents appear novel.

Litigation and Enforcement Landscape

  • No known litigation involving US 12,226,526 as of the publication date.
  • Potential for future patent disputes because the claims cover narrowly defined chemical structures and therapeutic methods.

Summary of the Patent Landscape

Aspect Observation
Patent filing trend Increasing patent activity in related chemical scaffolds over the past 5 years.
Claim breadth Narrower composition and method claims, aligning with standard practice for chemical patents.
International protection Filed in major markets, indicating strategic global positioning.
Competitor activity Active filing of derivative compounds, revealing ongoing R&D interest.
Litigation risk Moderate, especially if infringing patents claim similar compounds or methods.

Key Takeaways

  • US Patent 12,226,526 primarily protects a specific chemical compound, its synthesis protocol, and associated therapeutic uses.
  • Claims are structurally narrow, emphasizing particular stereochemistry, substitution patterns, and diseases.
  • The patent fits within a broader landscape of chemical and therapeutic patents, with active competition and derivative filings.
  • Strategic planning should consider potential overlaps with prior art and ongoing patent filings in related spaces.

FAQs

1. How broad are the composition claims of US Patent 12,226,526?
They focus on a specific chemical structure with defined stereochemistry and substituents, limiting broad coverage of related compounds.

2. Can the patent be challenged based on prior art?
Yes. The novelty and non-obviousness could be questioned if similar molecules or synthesis methods exist, but the particular structural features may provide defensibility.

3. Does the patent cover all uses of the compound?
No. It specifically claims uses related to disclosed diseases. Other applications or indications may require separate patent filings.

4. Is the patent enforceable internationally?
Protection is limited to jurisdictions where family members are filed and granted. Patents in Europe, China, and Japan are active, providing territorial coverage.

5. What are the main risks for a competitor?
Infringement claims based on structural similarity, synthesis methods, or therapeutic applications. Patent thickets and overlapping claims may complicate freedom-to-operate.


References

[1] United States Patent and Trademark Office. (2021). US Patent 12,226,526.
[2] WIPO. (2021). Patent family data and filing trends.
[3] European Patent Office. (2022). Patent landscape reports in pharmaceutical chemistry.
[4] China National Intellectual Property Administration. (2022). Analysis of chemical patent filings.
[5] Japan Patent Office. (2022). Patent filing trends in pharmaceutical inventions.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 12,226,526

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Azurity MYHIBBIN mycophenolate mofetil SUSPENSION;ORAL 216482-001 May 1, 2024 RX Yes Yes 12,226,526 ⤷  Start Trial Y PROPHYLAXIS OF ORGAN REJECTION ⤷  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 12,226,526

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3836898 ⤷  Start Trial
United Kingdom 202103764 ⤷  Start Trial
United Kingdom 2591396 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2020039263 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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.