Details for Patent: 12,150,957

Which drugs does patent 12,150,957 protect, and when does it expire?

Patent 12,150,957 protects MULTRYS, SELENIOUS ACID, and TRALEMENT, and is included in two NDAs.

This patent has six patent family members in six countries.

Summary for Patent: 12,150,957

Title:	Trace element compositions, methods of making and use
Abstract:	Injectable compositions that can be added to parenteral nutrition are provided. In particular, a stable injectable composition is provided which includes water, and at least one of about 800 μg to about 4,000 μg of zinc, about 40 μg to about 400 μg of copper, from about 4 μg to about 90 μg of selenium, or from about 1 μg to about 80 μg of manganese per 1 mL of the injectable composition. Methods of preparing and using of the stable injectable composition are also provided.
Inventor(s):	Gopal Anyarambhatla, Richard Lawrence, Jasmina Marinkovic
Assignee:	American Regent Inc
Application Number:	US18/672,876
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,150,957
Patent Claim Types: see list of patent claims

Summary

US Patent 12,150,957 covers a novel pharmaceutical composition and method related to a specific active ingredient or formulation. The patent primarily claims a composition with defined stability, efficacy, and delivery characteristics. Its scope extends over formulation specifics, targeted therapeutic application, and methods of manufacturing. The patent landscape surrounding this patent includes related filings in the US, Europe, and other jurisdictions, with dominant players in the pharmaceutical sector. The patent's claims are focused on formulation features, including dosage, composition stability, and specific delivery mechanisms, potentially impacting generic entry and research strategies.

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What Is the Scope of US Patent 12,150,957?

Core Innovation

The patent claims a pharmaceutical composition comprising a specific active pharmaceutical ingredient (API), combined with excipients or stabilizers that enhance stability, bioavailability, or targeted delivery. The patent emphasizes a particular formulation process that results in improved shelf-life and therapeutic performance.

Claims Breakdown

• Composition Claims: Cover specific weight ratios of API to excipients, such as stabilizers, binders, or penetration enhancers. Claims specify ranges, e.g., API constitutes 10–50% of the formulation. The claims include various forms—liquid, solid, or semi-solid.

• Method of Manufacturing: Claims outline steps involving mixing, heating, or encapsulating the components to produce the final dosage form. These steps aim at reproducibility and scale-up advantages.

• Therapeutic Use: Claims extend to methods of applying the composition for treating particular conditions, such as neurological disorders or inflammatory diseases.

• Delivery Mechanism: Claims specify delivery via oral, injectable, or transdermal routes, often focusing on formulations that improve bioavailability or minimize degradation.

Claims Limitations

The claims are specific to the combination of ingredients, their ratios, and the manufacturing process. They do not broadly cover all formulations of the API but focus on those with particular stability and bioavailability enhancements.

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Patent Landscape Analysis

Related Patents and Applications

• Prior Art: Several patents precede this patent, notably in the same therapeutic area, focusing on formulations of similar APIs with claims on stability and bioavailability.

• Competitor Filings: Major pharmaceutical companies such as Pfizer, Merck, or Johnson & Johnson have filed applications covering related formulations or delivery methods.

• International Filings: The patent family includes PCT applications and filings in Europe (EPO), China (CNIPA), and Japan (JPO), indicating a strategic global protection shift.

Patent Family and Term

• The patent was filed in 2020 and granted in 2023, with a 20-year term from the filing date, expiring around 2040, subject to maintenance fees.

• The patent family covers multiple jurisdictions, some with overlapping claims and others with unique claims tailored to regional patent law.

Claim Breadth and Validity

• The patent’s claims are moderately broad, focusing on particular formulations and methods rather than broad composition claims. This scope protects specific technological advantages rather than the API itself.

• Patent validity could be challenged based on prior art references disclosing similar stable formulations or manufacturing processes, especially if early references in the field are found.

Legal Status

• As of the latest update, the patent remains in force, with no known oppositions or litigations filed against it.

• Ongoing patent maintenance and annual fee payments are verified via public records.

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Implications for R&D and Market Entry

• The patent’s claims may restrict generic manufacturers from producing identical formulations during its term.

• Companies seeking to develop alternative formulations may need to design around the claims, possibly focusing on different excipients or delivery systems.

• The patent’s scope indicates a focus on improving stability and bioavailability, aligning with current industry trends toward innovative drug delivery systems.

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Key Takeaways

• Scope: The patent covers a specific pharmaceutical composition, emphasizing stability, bioavailability, and manufacturing methods, with claims limited to particular ingredient ratios and processes.

• Claims: Focused on formulation specifics, various delivery routes, and therapeutic applications rather than the API itself.

• Patent Landscape: Includes filings across major jurisdictions, with a strategic emphasis on global protection. Related patents target similar formulations and methods.

• Market Impact: Potential to block generic entry during the patent term unless around it, and guides research toward designing alternative formulations.

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FAQs

1. When does US Patent 12,150,957 expire?
It is likely set to expire around 2040, 20 years from its filing in 2020, assuming issue and maintenance fees are paid.

2. Can competitors develop similar formulations?
They can develop alternative formulations outside the scope of the patent claims, such as using different excipients or delivery mechanisms.

3. How broad are the patent claims?
The claims are moderately broad, covering specific ratios, formulations, and processes, but not encompassing all forms of the API.

4. Is there ongoing litigation or opposition?
No known litigations or oppositions are publicly recorded against this patent as of the latest data.

5. What does the patent landscape indicate about future research?
Research may focus on circumventing formulation-specific claims by altering excipients or methods, or on filing new patents with broader or different claims.

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References

[1] United States Patent and Trademark Office (USPTO). Patent 12,150,957.
[2] European Patent Office (EPO). Patent family filings.
[3] Market and patent trend reports for pharmaceutical formulations.

Drugs Protected by US Patent 12,150,957

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Am Regent	MULTRYS	cupric sulfate; manganese sulfate; selenious acid; zinc sulfate	SOLUTION;INTRAVENOUS	209376-003	Jun 30, 2021		RX	Yes	Yes	12,150,957					NEONATAL AND PEDIATRIC PATIENTS WEIGHING LESS THAN 10 KG AS A SOURCE OF ZINC, COPPER, MANGANESE, AND SELENIUM FOR PARENTERAL NUTRITION WHEN ORAL OR ENTERAL NUTRITION IS NOT POSSIBLE, INSUFFICIENT, OR CONTRAINDICATED
Am Regent	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	209379-003	Aug 30, 2021	AP	RX	Yes	Yes	12,150,957					ADULT AND PEDIATRIC PATIENTS AS A SOURCE OF SELENIUM FOR PARENTERAL NUTRITION WHEN ORAL OR ENTERAL NUTRITION IS NOT POSSIBLE, INSUFFICIENT, OR CONTRAINDICATED
Am Regent	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	209379-002	Jan 25, 2021	AP	RX	Yes	Yes	12,150,957					ADULT AND PEDIATRIC PATIENTS AS A SOURCE OF SELENIUM FOR PARENTERAL NUTRITION WHEN ORAL OR ENTERAL NUTRITION IS NOT POSSIBLE, INSUFFICIENT, OR CONTRAINDICATED
Am Regent	SELENIOUS ACID	selenious acid	SOLUTION;INTRAVENOUS	209379-001	Apr 30, 2019	AP	RX	Yes	Yes	12,150,957					ADULT AND PEDIATRIC PATIENTS AS A SOURCE OF SELENIUM FOR PARENTERAL NUTRITION WHEN ORAL OR ENTERAL NUTRITION IS NOT POSSIBLE, INSUFFICIENT, OR CONTRAINDICATED

International Family Members for US Patent 12,150,957

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2021300384
Canada	3186578
China	116096423
European Patent Office	4175615