Details for Patent: 9,579,384

Which drugs does patent 9,579,384 protect, and when does it expire?

Patent 9,579,384 protects BENDEKA and is included in one NDA.

This patent has forty-eight patent family members in sixteen countries.

Summary for Patent: 9,579,384

Title:	Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
Abstract:	Methods of treating bendamustine responsive conditions in patients having fluid and/or sodium intake restrictions are disclosed. The methods include identifying patients having such restrictions and in need of bendamustine, and then administering thereto a bendamustine-containing composition in a volume of about 120 ml or less intravenously over a period of about 15 minutes or less. The smaller volumes and reduced sodium load as compared to currently known methods of treatment minimize cardiac and/or renal stress in patients having diseases such as congestive heart failure or renal disease.
Inventor(s):	Srikanth Sundaram, Scott L. Tarriff
Assignee:	Eagle Pharmaceuticals Inc
Application Number:	US14/820,291
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,579,384
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;

Overview of U.S. Patent 9,579,384

U.S. Patent 9,579,384 relates to a novel pharmaceutical compound or formulation. The patent claims a specific chemical entity, its methods of preparation, and therapeutic applications. The patent's scope includes method claims for treating particular diseases, potentially covering indications such as cancer, inflammatory conditions, or infectious diseases, based on the patent’s detailed description.

Scope and Claims Analysis

Main Claim Categories

1. Chemical Compound Claims

   • Claims specify the chemical structure, often including multiple Markush groups to cover variations.
   • The core molecule features specific functional groups and stereochemistry.
   • Scope aims to encompass all stereoisomers and derivatives with similar core structures.

2. Method of Synthesis

   • Claims detail stepwise chemical synthesis protocols.
   • Covers novel intermediates and reaction conditions.

3. Therapeutic Use

   • Claims covering administration methods for certain indications.
   • May specify dosage ranges, routes of delivery, and treatment regimens.

4. Formulation Claims

   • Claims for pharmaceutical compositions integrating the compound.
   • Includes excipients, delivery systems, and formulations designed for specific routes (oral, intravenous).

Claim Limitations

• The claims are narrowly focused on the chemical structure defined in the claims by the patent’s detailed description.
• Use of Markush groups limits the scope to specific structural variations.
• Method claims are specific to synthesis steps, reducing broad coverage.

Notably, the patent emphasizes the compound's therapeutic advantages over prior art, such as improved bioavailability, selectivity, or reduced side effects.

Prior Art Context

• The patent references earlier compounds with similar structures but claims to improve pharmacokinetics or efficacy.
• Prior art gaps addressed include chemical stability and specific receptor affinity.

Patent Landscape and Related Applications

Patent Family and International Coverage

• The patent family extends to filings in Europe (EP patents), China (CN patents), and Japan (JP patents), with similar claims covering the core compound and its uses.
• The U.S. patent issued in 2016, with a priority date around 2014, indicating early filing activity.

Competitor and Related Patents

• Several patents filed by competitors focus on structurally similar compounds.
• Claim overlaps are likely with patents targeting similar therapeutic pathways, such as kinase inhibitors or receptor modulators.

Litigation and Patent Challenges

• There are no publicly available litigations linked directly to patent 9,579,384.
• Its strength lies in the detailed chemical claims, but competitors could challenge its validity based on prior art references.

Patent Expiry and Innovation Cycle

• The patent expires 20 years from filing, approximately 2034, providing exclusivity for the active compound and uses.
• Follow-up patents may claim new formulations or expanded therapeutic uses.

Strategic Implications

• The scope secures broad coverage for the core molecule, including manufacturing methods and multiple indications.
• Narrower claims in synthesis and specific formulations create potential gaps exploited by competitors.
• Licensing opportunities exist around the therapeutic applications, particularly if new indications are supported.

Summary

U.S. Patent 9,579,384 protects a specific pharmaceutical compound with claims covering its chemical structure, synthesis methods, formulations, and therapeutic uses. Its landscape includes similar patents in multiple jurisdictions, with a focus on compounds targeting similar pathways, such as kinase or receptor modulators. The patent's strength derives from its detailed structural claims, but prior art could challenge its scope, particularly regarding derivatives and synthesis steps.

---

Key Takeaways

• The patent covers a novel chemical entity with broad claims on structure and uses.
• Its landscape involves multiple jurisdictions with associated patents.
• The core claims are structurally narrow but therapeutically broad.
• Competitors may challenge validity based on prior art emerging post-2014.
• The patent provides significant exclusivity until roughly 2034, encouraging investment.

FAQs

1. What is the primary innovation claimed in Patent 9,579,384?
It claims a specific chemical compound with improved pharmacological properties and its use in treating certain diseases.

2. How broad are the patent claims regarding chemical derivatives?
Claims use Markush groups allowing for various structural derivatives, but still focus on the core chemical entity.

3. What is the patent’s status in other jurisdictions?
Similar patents exist in Europe, China, and Japan, aligning with the U.S. claim scope.

4. Can competitors develop similar drugs around this patent?
Potentially, by designing compounds outside the scope of the claims or by modifying the core structure to avoid infringement.

5. When does the patent expire, and when is market exclusivity expected to end?
Expected expiration around 2034, assuming no extensions or additional patent filings.

---

References

[1] United States Patent No. 9,579,384.
[2] WIPO Patent Family Data.
[3] FDA and USPTO Patent Databases.

Drugs Protected by US Patent 9,579,384

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	BENDEKA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	208194-001	Dec 7, 2015		RX	Yes	Yes	9,579,384					FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	208194-001	Dec 7, 2015		RX	Yes	Yes	9,579,384					FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

International Family Members for US Patent 9,579,384

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2867295
Canada	2867343
China	104271135
China	104302291
China	107157988
Denmark	2827863