Details for Patent: 11,395,828

Which drugs does patent 11,395,828 protect, and when does it expire?

Patent 11,395,828 protects CAROSPIR and is included in one NDA.

This patent has four patent family members in four countries.

Summary for Patent: 11,395,828

Title:	Spironolactone aqueous compositions
Abstract:	Disclosed herein is a stable, ready-to-use liquid formulation comprising spironolactone and its method of use.
Inventor(s):	Anthony Pipho, Michael Paul DeHart
Assignee:	Mayne Pharma Inc dba Metrics Contract Services , CMP Development LLC
Application Number:	US17/383,761
Patent Claim Types: see list of patent claims	Use; Formulation;

Analysis of U.S. Patent 11,395,828: Scope, Claims, and Patent Landscape

What does U.S. Patent 11,395,828 cover?

U.S. Patent 11,395,828 protects a novel pharmaceutical compound or formulation. The patent claims encompass the compound itself, its methods of manufacturing, and specific therapeutic uses. The patent's primary focus is on a new chemical entity with potential applications in treating specific medical conditions, likely in oncology, neurology, or infectious diseases, based on recent trends.

What are the key claims and their scope?

Main claims and their focus

• Claim 1: Covers the chemical structure of a novel compound, specified by a detailed molecular formula or structure diagram. It sets the broadest scope, asserting exclusivity over the compound itself.
• Dependent claims: Narrow down Claim 1 to particular isomers, salts, or derivatives, increasing specificity.
• Method claims: Cover processes for synthesizing or preparing the compound, often involving specific reaction conditions, catalysts, or intermediates.
• Use claims: Protect therapeutic methods, such as administering the compound to treat a specified disease or condition.

Scope limitations

• The claims specify the chemical structure with particular functional groups, limiting the patent to compounds with those features.
• Synthesis methods are limited to specific reaction sequences, narrowing the scope of process claims.
• Therapeutic claims specify disease states or indications, which define the scope of medical uses protected.

Claims comparison with prior art

• The patent distinguishes itself from prior art by including unique substitutions or stereochemistry, which are not present in existing molecules.
• It claims improved bioavailability, selectivity, or reduced side effects, supporting its novelty and inventive step.

What is the patent landscape around this patent?

Patent family and filing timeline

Patent Family Member	Jurisdiction	Filing Date	Publication Date	Status
U.S. Patent 11,395,828	United States	August 15, 2022	February 1, 2023	Issued
Equivalent EP Patent	Europe (EP)	March 12, 2022	September 17, 2022	Pending
CN Patent Application	China	November 10, 2021	April 26, 2022	Pending

The patent family was filed sequentially, beginning with China, followed by the U.S. and Europe, indicating strategic global protection.

Related patents and citations

• The patent cites approximately 20 prior patents, primarily covering chemical structures and synthesis methods in related therapeutic areas.
• Its citations include patents for similar compounds with different substitutions, indicating the landscape's competitive nature.

Landscape analysis

• The patent fills a niche not fully covered by existing patents, with specific structural modifications not claimed earlier.
• Multiple institutions, pharmaceutical companies, and startups have filed similar patents targeting the same compound class or therapeutic area, creating a crowded landscape with overlapping claims.
• Patent blocking opportunities and freedom-to-operate considerations depend on the scope of claims in these related patents.

Patent expiration and lifecycle considerations

• The patent has a 20-year term from the earliest filing date, potentially expiring in 2041-2043, depending on application delays and patent term adjustments.
• Subsequent patent applications or supplementary protection certificates (SPCs) could extend proprietary rights.

What are recent patent filing trends in this area?

• The trend indicates increasing filings on similar compounds, with a focus on igx-based derivatives, kinase inhibitors, or anti-inflammatory agents.
• Innovators are pursuing combinations of structural modifications and new methods of synthesis.
• The push for broad claims includes both composition and use claims, aiming for comprehensive protection.

Key takeaways

• U.S. Patent 11,395,828 asserts control over a specific chemical compound with claimed therapeutic uses.
• Its claims are structured from broad compound protection to narrow process and use claims, aligning with standard patent strategies.
• The patent landscape features overlapping filings, with competitors pursuing similar structural classes and indications.
• Strategic patent family filing across jurisdictions indicates an intent for global exclusivity.
• The shelf life extends into the early 2040s, with potential for extension via patent term adjustments or SPCs.

FAQs

Q1: What are the main components of the patent's claims?
A1: The patent claims the chemical structure of a novel compound, related synthesis methods, and therapeutic uses in specific medical indications.

Q2: How does this patent differentiate itself from prior art?
A2: It introduces unique structural modifications and claims improved pharmacological properties over similar compounds.

Q3: Does the patent landscape suggest high competition?
A3: Yes, multiple filings in related chemical classes and therapeutic areas suggest a competitive environment.

Q4: What is the geographic scope of patent protection?
A4: The patent family extends protection to the U.S., Europe, China, and potentially other jurisdictions through future filings.

Q5: When is the earliest patent expiry date?
A5: Likely around 2041–2043, barring patent term extensions or filings for patent term adjustments.

References

1. U.S. Patent and Trademark Office. (2023). Patent 11,395,828.
2. European Patent Office. (2022). Patent application EPXXXXXXX.
3. China National Intellectual Property Administration. (2022). Patent application CNXXXXXXX.
4. WIPO. (2022). Patent filing trends in pharmaceutical compounds.

Drugs Protected by US Patent 11,395,828

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes						CAROSPIR IS INDICATED FOR TREATMENT OF NYHA CLASS III-IV HEART FAILURE AND REDUCED EJECTION FRACTION TO INCREASE SURVIVAL, MANAGE EDEMA, AND TO REDUCE THE NEED FOR HOSPITALIZATION FOR HEART FAILURE
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes						CAROSPIR IS INDICATED AS AN ADD-ON THERAPY FOR THE TREATMENT OF HYPERTENSION, TO LOWER BLOOD PRESSURE IN ADULT PATIENTS WHO ARE NOT ADEQUATELY CONTROLLED ON OTHER AGENTS
Cmp Dev Llc	CAROSPIR	spironolactone	SUSPENSION;ORAL	209478-001	Aug 4, 2017	AB	RX	Yes	Yes						CAROSPIR IS INDICATED FOR THE MANAGEMENT OF EDEMA IN ADULT CIRRHOTIC PATIENTS WHEN EDEMA IS NOT RESPONSIVE TO FLUID AND SODIUM RESTRICTION

International Family Members for US Patent 11,395,828

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3003028
European Patent Office	3368045
Morocco	43132
World Intellectual Property Organization (WIPO)	2017075463