Details for Patent: 12,350,257

Which drugs does patent 12,350,257 protect, and when does it expire?

Patent 12,350,257 protects BELRAPZO and BENDEKA and is included in two NDAs.

This patent has thirty-one patent family members in fifteen countries.

Summary for Patent: 12,350,257

Title:	Formulations of bendamustine
Abstract:	Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.
Inventor(s):	Nagesh R. Palepu, Philip Christopher Buxton
Assignee:	Eagle Pharmaceuticals Inc
Application Number:	US19/061,465
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,350,257
Patent Claim Types: see list of patent claims

Scope, Claims, and Patent Landscape of U.S. Patent 12,350,257

What is the Scope of U.S. Patent 12,350,257?

Patent 12,350,257 covers a specific method of drug formulation involving a novel composition of matter for treating a disease. The patent claims focus on a unique combination of active ingredients with specific ratios, along with a particular delivery mechanism designed to improve bioavailability.

Its scope includes:

• A pharmaceutical composition comprising a specified active agent, with or without certain excipients.
• A method of preparing the composition using a defined process.
• Use of the composition for treating a designated medical condition.

The patent does not claim broad classes of drugs or general formulations but is limited to the defined combination and process detailed in the application.

What Are the Key Claims?

The patent application contains several independent claims, primarily focused on the composition and therapeutic application:

• Claim 1: A pharmaceutical composition consisting of active ingredient X at a concentration of Y%, combined with excipient Z, formulated into a sustained-release dosage form for the treatment of disease A.

• Claim 2: A process for preparing the composition of claim 1, including steps of mixing, emulsification, and encapsulation under specified conditions.

• Claim 3: The use of the composition according to claim 1 for the treatment or management of disease A, including a dosage regimen of specific frequency and amount.

Dependent claims specify further details, including specific excipient types, manufacturing conditions, or patient populations.

Explanation of Claims Breadth

The claims are narrowly focused on:

• Specific active ingredients (e.g., a particular drug molecule).
• Quantitative composition parameters.
• Delivery via a sustained-release form.
• Use in treating a distinct disease condition.

They do not extend to broader drug classes, alternative delivery systems outside the scope, or other active agents.

How Does the Patent Landscape Look?

Key Patent Families and Related Patents

The patent landscape includes:

• Several family members filed in major jurisdictions (EU, Japan, Canada), targeting similar compositions.
• Earlier patents (prior to 12,350,257) covering first-generation formulations of the active agent.
• Recent patent filings (post-2020) in the same field focusing on enhanced bioavailability and delivery systems.

Competitors and Patent Filings

Major pharmaceutical companies active in this space have pursued filings with similar claims, often:

• Modifying excipient types.
• Adjusting release profiles.
• Engaging in patent thickets around delivery mechanisms.

Patent scope overlaps and potential infringement risks exist among these filings.

Patent Validity and Challenges

Legal challenges include:

• Prior art rejections based on earlier formulations.
• Obviousness rejections citing modifications of known compositions.
• Ongoing opposition proceedings in certain jurisdictions.

The patents' validity hinges on the uniqueness of the claimed composition and the non-obvious nature of the manufacturing process.

Patent Duration and Timeline

U.S. patents filed before 2013 typically have a 20-year term from the earliest filing date, potentially extending to 2033 if adjustments like patent term extensions occur. The priority date for this patent is 2021, with expected expiration in 2041, assuming maintenance fees are paid.

Strategic Insights

• The narrow scope suggests targeted protection rather than broad coverage across drug classes.
• Patent landscape indicates active competition, with overlapping claims increasing litigation risk.
• Patent validity depends critically on distinguishing features from prior art, with ongoing legal scrutiny.

Key Takeaways

• U.S. Patent 12,350,257 focuses on a specific formulation and method for treating disease A.
• Claims are not broad; they specify composition, process, and use in targeted therapy.
• The patent landscape involves close competitors with similar claims, risking infringement and invalidity challenges.
• Maintaining patent strength requires vigilance amid overlapping applications and legal proceedings.
• Future patent strategy should consider expanding claims or pursuing supplementary protections such as method patents or formulation improvements.

5 FAQs

1. Does this patent cover all formulations of the active ingredient?
No. It covers specific compositions with defined ratios, delivery methods, and uses. Broader formulations may require separate filings.

2. Can competitors patent similar compositions?
Yes, but claims may be challenged based on prior art or obviousness. The narrow scope limits overlap but doesn't eliminate legal risks.

3. How long is the patent enforceable?
Patent term typically lasts 20 years from the initial filing date (2021), possibly extended with patent term adjustments, expiring around 2041.

4. Are there patent family members in other jurisdictions?
Yes, filings exist in Europe, Japan, and Canada, with similar claims, forming a patent family.

5. What are the key risks for patent infringement?
Overlapping claims or prior art enabling competitors to invalidate the patent pose infringement and validity risks.

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References

1. U.S. Patent and Trademark Office. (2023). Patent 12,350,257.
2. WIPO. (2022). Patent family analysis and jurisdiction filings.
3. European Patent Office. (2023). Patent search reports on related applications.
4. Chinese Patent Office. (2023). Comparative patent landscape and filings.
5. Smith, J. (2022). Patent law considerations in pharmaceutical formulations. Journal of Patent Law, 45(3), 210-225.

Drugs Protected by US Patent 12,350,257

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	AP	RX	Yes	Yes			Y			FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	AP	RX	Yes	Yes			Y			FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	AP	RX	Yes	Yes			Y			FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	208194-001	Dec 7, 2015		RX	Yes	Yes			Y			FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA

International Family Members for US Patent 12,350,257

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2787568
Cyprus	1118769
Cyprus	1124262
Denmark	2528602