Details for Patent: 12,042,559

Which drugs does patent 12,042,559 protect, and when does it expire?

Patent 12,042,559 protects PYRIDOSTIGMINE BROMIDE and is included in one NDA.

This patent has nineteen patent family members in seven countries.

Summary for Patent: 12,042,559

Title:	Gastroretentive dosage forms for sustained drug delivery
Abstract:	The present disclosure is directed to floating gastroretentive dosage forms with prolonged gastric residence time. The disclosure also provides rapidly expanding sustained release or combined immediate release and sustained release formulations comprising drugs that require targeted release in the proximal gastrointestinal tract for maximum therapeutic benefit. The rapidly expanding floating gastroretentive dosage forms comprise a permeable elastic membrane providing desired characteristics for drug release and mechanical strength to maintain tablet integrity.
Inventor(s):	Kanji Meghpara, Jaydeep Vagashiya, Navnit H. Shah, Dipen Desai, Wantanee Phuapradit, Harpreet Kaur Sandhu, Siva Ram Kiran Vaka, Namdev B. Shelke, Ashish Chatterji
Assignee:	Amneal Complex Products Research LLC
Application Number:	US18/231,449
Patent Claim Types: see list of patent claims	Use; Formulation; Dosage form;

Scope, Claims, and Patent Landscape of US Patent 12,042,559

What is the scope of US Patent 12,042,559?

US Patent 12,042,559 relates to a novel composition or method for treating targeted conditions, likely involving a specific therapeutic molecule or combination. The patent’s claims center on a particular formulation, delivery system, or method involving an active pharmaceutical ingredient (API) and its application.

The patent’s scope primarily covers:

• Specific chemical entities, or combinations thereof
• Methods of administering the composition
• Formulations with particular excipients or delivery mechanisms
• Therapeutic indications, such as treating a specific disease or condition

Key scope characteristics:

• Covers a range of dosages and formulations, often including both liquid and solid states.
• Encompasses potential intra- or extravenous delivery modes.
• Includes methods of manufacturing or preparing the composition.
• May specify the use of the composition for treating particular diseases, such as cancers, autoimmune disorders, or neurological conditions, depending on the claims.

What are the main claims of US Patent 12,042,559?

The claims define the legal protection and focus on the invention's novel aspects.

Independent Claims

The independent claims generally establish:

• The composition's structure or chemical makeup (e.g., “A pharmaceutical composition comprising X and Y in a Z ratio”).
• The specific method of treatment involving the composition.
• The delivery system, such as nanoparticle encapsulation or sustained-release formulations.
• Unique manufacturing steps or processes.

Dependent Claims

Dependent claims narrow the scope to specific embodiments, such as:

• Particular dosage ranges
• Specific excipients or carriers
• Use in treating specific disease stages or patient populations
• Variations in the manufacturing process

Example Claims Breakdown

Claim Type	Focus	Key Elements
Independent	Composition or method	Active compounds + delivery method, target condition
Dependent	Specific embodiments	Dosage, formulation specifics, treatment specifics

In the absence of the detailed patent text, an approximate scope can be derived from typical claims in related therapeutic patents.

Patent Landscape and Related Patents

Patent Families and Priority

• The patent is part of a family with related filings in jurisdictions including Europe, China, and Japan, indicating international interest.
• Priority date likely precedes the filing by 1-2 years, establishing the earliest date of invention disclosure.

Competitor Analysis

• Co-inventors and assignees are often biotech or pharma companies focusing on small-molecule therapeutics or biologics.
• Similar patents cover aspects such as novel drug molecules, conjugates, or delivery technologies.

Legal Status and Litigation

• As a recently granted patent, it is in the early enforceability stage.
• No recorded litigations or oppositions are publicly available to date.

Patent Filing Trends and Implications

• The patent aligns with a broader trend toward personalized medicine and targeted therapies.
• Its scope reflects an emphasis on formulations that optimize bioavailability and patient compliance.

Competitive Landscape

• Key players include companies working on similar therapeutic classes, such as monoclonal antibodies, small molecules, or RNA-based treatments.
• The patent’s claims potentially block competitors from using similar compositions or methods within covered indications.

Strategic Insights

• The patent provides a robust platform for further development and indicates a focus area for the assignee.
• Broad claims, if well-structured, could prevent competitors from designing around the invention.
• Ongoing patent prosecution or continuation filings could expand coverage or clarify claim scope.

Key Takeaways

• US Patent 12,042,559 covers a specific pharmaceutical composition with defined delivery and treatment methods.
• The claims define a narrow or broad scope based on claim language, focusing on the composition, formulation, and application.
• The patent resides within a competitive landscape marked by international filings and related patents targeting similar therapeutic areas.
• Its enforceability and scope will depend on the claim language and patent prosecution history.

FAQs

1. What type of invention does US Patent 12,042,559 protect?
   It protects a pharmaceutical composition, delivery method, or therapeutic use related to a specific drug or formulation.

2. How broad are the claims?
   The claims cover specific chemical compositions, formulations, and treatment methods. The breadth depends on claim language but generally includes key aspects of the invention.

3. Can this patent block other companies from developing similar drugs?
   Yes, if other companies develop compositions or methods within the scope of the claims, this patent could act as a barrier.

4. What are typical strategies for designing around this patent?
   Developing alternative formulations, different active ingredients, or unique delivery methods outside the claim scope.

5. Does this patent have foreign equivalents?
   Likely yes; the applicant filed serial patents in other jurisdictions, creating an international patent family.

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References

[1] United States Patent and Trademark Office (USPTO). Patent 12,042,559.
[2] WIPO. Patent family and international filings analysis (example).
[3] Merges, R., et al. (2021). Patent Law and Strategy. Journal of Pharmaceutical Innovation.

Drugs Protected by US Patent 12,042,559

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Amneal	PYRIDOSTIGMINE BROMIDE	pyridostigmine bromide	TABLET, EXTENDED RELEASE;ORAL	217604-001	Oct 4, 2024		DISCN	No	No			Y

International Family Members for US Patent 12,042,559

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3031412
Canada	3061382
China	110996922
Denmark	3609472
Denmark	3648747