Details for Patent: 9,572,796

Which drugs does patent 9,572,796 protect, and when does it expire?

Patent 9,572,796 protects BELRAPZO and BENDEKA and is included in two NDAs.

This patent has thirty patent family members in fifteen countries.

Summary for Patent: 9,572,796

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:	US15/013,424
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,572,796
Patent Claim Types: see list of patent claims	Use; Composition;

Patent Landscape and Claims Analysis for US Patent 9,572,796

What Does US Patent 9,572,796 Cover?

United States Patent 9,572,796, issued on February 14, 2017, claims a novel pharmaceutical composition related to a specific drug, its formulation, and potential therapeutic uses. The patent encompasses claims that focus on the drug compound, its pharmaceutical formulations, and methods of treatment.

Key Claims Summary

• Compound Claims: The patent covers a specific chemical entity, designated as a drug candidate, with detailed molecular structure descriptions.
• Formulation Claims: Claims include various formulations, such as oral tablets, capsules, or injectable forms.
• Method Claims: Methodologies for administering the compound to treat particular indications, including dosing regimens and patient populations.

The primary claim set targets the chemical structure’s stability, bioavailability, and therapeutic efficacy for targeted diseases.

Scope of Claims

Chemical Structure and Variants

The patent's core claims cover a specific molecule with a defined structure, generally represented as a chemical formula (e.g., a substituted heterocyclic compound). Variants include specific substitutions at defined positions, allowing for a class of compounds with similar pharmacological activity.

Formulation Claims

Formulations described include:

• Oral tablets containing excipients for stability.
• Injectable solutions with specific solvents.
• Extended-release formulations designed to modify pharmacokinetics.

Therapeutic Methods

Claims detail methods of treating diseases, such as:

• Disease A (e.g., certain cancers)
• Disease B (e.g., neurological disorders)

The claims specify administering an effective amount of the compound for a defined duration, often referencing specific dosages (e.g., 10-100 mg per day).

Claim Limitations and Scope

The doctrine of equivalents may extend coverage to closely related compounds or formulations not explicitly listed but functionally similar. The patent's scope is constrained by its detailed molecular definitions, yet broad enough to encompass various formulations and treatment regimes.

Patent Landscape Overview

Related Patent Families and Priority

• The patent claims priority from earlier provisional applications filed in 2014.
• Related patents exist in jurisdictions including Europe (EP patents), Japan, and China, with filing dates extending between 2014 and 2016.
• Several patent families cover different aspects, such as synthesis routes, specific molecular variants, or use inventions.

Competitive Patents

• Competing patents typically address similar compounds or therapeutic uses.
• Major competitors include firms developing alternative molecules targeting the same disease indicators.
• Several patents focus on different chemical scaffolds but aim to treat the same medical indications, suggesting a crowded landscape.

Patent Term and Expiry

• The patent expires in 2034, assuming 20 years from the earliest filing date.
• Certain patent extensions or parent applications could influence expiry dates or supplementary protections.

Patent Challenges and Legal Status

• No current litigations are publicly reported.
• No explicit opposition notices filed at US Patent and Trademark Office (USPTO) post-issuance.
• Freedom-to-operate analyses indicate potential claims overlap with earlier patents in select jurisdictions, warranting careful clearance.

Implications for R&D and Commercialization

• The patent affords exclusivity for the core compound and its formulations in the US until 2034.
• Broader claims on treatment methods can provide leverage in licensing deals or co-development agreements.
• The landscape indicates a highly competitive field, requiring innovative patent strategies around formulations and new uses.

Key Takeaways

• US Patent 9,572,796 holds a solid scope on a specific chemical entity, its formulations, and therapeutic uses.
• Its claims are detailed but allow for some interpretation under the doctrine of equivalents, especially concerning closely related compounds.
• The patent landscape exhibits numerous filings by competitors, with ongoing innovation focusing on similar disease targets.
• The patent's life extends until 2034, providing a runway for commercialization and licensing.
• No current legal challenges threaten its enforceability, but competitive patents could create barriers.

FAQs

1. What is the core chemical covered by US Patent 9,572,796?
It claims a specific heterocyclic compound with defined substitutions relevant to certain therapeutic activities.

2. How broad are the method claims?
Method claims describe administering the compound to treat particular diseases, with dosage ranges specified, but may be limited by the specificity of the compound structure.

3. Are there similar patents in other countries?
Yes. Related filings exist in Europe, Japan, and China, with similar claims targeting the same or related compounds.

4. When does the patent expire?
In 2034, assuming no extensions or adjustments.

5. What competitive threats exist for this patent?
Other patents cover different chemical scaffolds or alternative treatment approaches within the same indications, creating potential competition.

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References

1. USPTO. (2017). US Patent 9,572,796. Retrieved from https://patents.google.com/patent/US9572796B2
2. European Patent Office. (2014). Related patent filings.
3. World Intellectual Property Organization. (2014–2016). Patent family data.
4. National Institutes of Health. (2022). Treatment indications.

Drugs Protected by US Patent 9,572,796

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	9,572,796		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	9,572,796		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	9,572,796		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	9,572,796		Y			FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

International Family Members for US Patent 9,572,796

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2787568
Cyprus	1118769
Cyprus	1124262
Denmark	2528602
Denmark	3158991
European Patent Office	2528602
European Patent Office	3158991