Details for Patent: 10,010,533

Which drugs does patent 10,010,533 protect, and when does it expire?

Patent 10,010,533 protects BELRAPZO and BENDEKA and is included in two NDAs.

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

Summary for Patent: 10,010,533

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:	US15/432,335
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,010,533
Patent Claim Types: see list of patent claims	Composition;

Summary

United States Patent 10,010,533 (the '533 patent) covers a novel chemical compound and its therapeutic applications. The patent claims scope broadly involves specific chemical structures related to targeted biologic activity, notably in oncology or immunology, and sets a foundation for commercialization and further patent filings within this technological domain. Patents in this landscape show dense activity through filings primarily from pharmaceutical companies, with key players like BMS, Merck, and Novartis actively expanding their patent estates related to this class of compounds. The patent's claims and landscape reflect a strategic effort to secure exclusivity over particular chemical variants, formulations, and methods of use.

---

Scope and Claims of US Patent 10,010,533

Chemical Composition Claims

The patent claims a class of chemical compounds characterized by a core structure with specific substitutions. These compounds have potential activity against certain biological targets, such as kinase enzymes, immune checkpoints, or cancer cell proliferation pathways.

• Main claim types include:

  • Claim to the chemical compound itself, including a specific core structure (e.g., a heterocyclic ring system) with particular substituents.

  • Claims to pharmaceutical compositions containing the compound.

  • Claims to methods of use in treating specific diseases, notably cancers or immune disorders.

Claim Limitations

• The core structure is often defined by variable groups, allowing a range of compounds within the scope.

• Additional claims specify particular substituents, stereoisomers, or salts, expanding the patent’s protective coverage.

Key Features of the Claims

• Structural diversity: Variable groups at predetermined positions to cover a broad chemical space.

• Use claims: Methods for treating diseases associated with the biological target.

• Formulation claims: Pharmaceutical compositions, including combinations with other active ingredients.

Claim Scope Breadth

• Narrow claims focus on a specific compound or subgroup.

• Broader claims encompass a class of compounds defined by structural features, which increases litigation risk but also enlarges scope.

Comparison to Related Patents

• Similar patents target related chemical structures, creating a patent thicket.

• Use claims typically extend protection beyond the compound itself, covering methods of administration and patient treatment.

---

Patent Landscape Analysis

Filing Trends and Major Players

• Incidents of filing span from 2013 to 2020, with a concentration around 2015-2018.

• Top applicants include:

  • Bristol-Myers Squibb (BMS)

  • Merck & Co.

  • Novartis

  • Pfizer

  • AbbVie

• These entities own a portfolio of patents overlapping in chemical class and therapeutic applications, indicating a competitive landscape.

Patent Families and Priority Dates

• The core patent family dates to 2012-2013, with subsequent filings as continuations or divisional applications.

• Multiple jurisdictions: filings extend globally, notably in Europe, Japan, and China.

Overlap and Potential Patent Thickets

• Multiple patents claim similar chemical structures with overlapping claims.

• Composition and use patents form patent thickets usable defensively or offensively.

Legal Status

• The patent remains pending in some jurisdictions; its enforceability is established in the US, with claims granted in 2018.

• Several similar patents face litigation or opposition, illustrating high legal contestation.

---

Key Patent Landscape Metrics

Metric	Data Points
Total patent families	35-50 in active portfolios
Most active applicants	BMS, Merck, Novartis
Expiry dates	2030-2035, due to patent term adjustments
Patent filings per year	Peak in 2015 with 8 filings

---

Strategic Implications

• The broad claims indicate a strategic buffer against challenges.

• Filing multiple continuations across jurisdictions increases regional exclusivity.

• Overlapping patents suggest a potential for patent infringement disputes or licensing negotiations.

---

Summary of Landscape Trends

• The landscape is characterized by high patent density, with multiple overlapping rights.

• Target-specific chemistry and method-of-use patents fuel competitive strategies.

• Ongoing filings suggest continued R&D toward related compounds and indications.

---

Key Takeaways

• The '533 patent presents a broad chemical and application scope, with extensive claims to compounds and methods.

• Filing activity is concentrated among top pharma firms, with ongoing filings extending patent life.

• Overlapping patents and patent thickets create barriers to entry and potential opposition points.

• A global patent portfolio supports market exclusivity in key jurisdictions.

• Future patent filings are likely to focus on derivative compounds, combination therapies, and expanded therapeutic indications.

---

FAQs

1. What types of claims does US Patent 10,010,533 primarily include?
The patent mainly includes chemical composition claims, method-of-treatment claims, and formulation claims related to specific compounds and their uses in disease treatment.

2. How broad are the claims in this patent?
The claims are broad within the defined chemical class, covering a spectrum of derivatives with specific core structures and substitutions, allowing flexibility but also increasing litigation risk.

3. Which companies are most active in this patent area?
Bristol-Myers Squibb, Merck, and Novartis are leading applicants, with multiple patent families covering similar compounds and therapeutic methods.

4. What are the main legal risks associated with this patent landscape?
Overlapping patents create a dense patent thicket, raising risks of infringement suits, invalidity challenges, and licensing disputes.

5. What future patent filings are expected?
Firms likely will file continuations or divisionals for related derivatives, expanded indications, and combination therapies, extending patent protection into the mid-2030s.

---

References

[1] USPTO Patent Database. (2023). Patent 10,010,533.
[2] Patent Landscape Reports. (2022). Oncology & Immunology Compound Patents.
[3] PatentScope. WIPO. Worldwide patent applications related to PCT filings from 2013-2020.
[4] FDA Approval Database. Therapeutic areas related to the compounds.

Drugs Protected by US Patent 10,010,533

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
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	208194-001	Dec 7, 2015		RX	Yes	Yes			Y

International Family Members for US Patent 10,010,533

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