Details for Patent: 8,735,452

Which drugs does patent 8,735,452 protect, and when does it expire?

Patent 8,735,452 protects CALDOLOR and is included in one NDA.

This patent has twenty-three patent family members in nine countries.

Summary for Patent: 8,735,452

Title:	Treating patients with intravenous ibuprofen
Abstract:	Methods of treating a patient in need thereof, comprising administering to the critically ill patient an intravenous pharmaceutical composition comprising ibuprofen in an amount effective to treat at least one condition in the patient chosen from pain, inflammation, and fever and to provide a clinically relevant effect on mean arterial pressure of the patients during the dosage interval comprising no increase or no statistically significant increase in mean arterial pressure.
Inventor(s):	Leo Pavliv, Amy Dix Rock
Assignee:	Cumberland Pharmaceuticals Inc
Application Number:	US12/699,595
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Patent 8,735,452 Scope, Claims, and Landscape Analysis

What is the scope and content of patent 8,735,452?

Patent 8,735,452 covers a specific pharmaceutical formulation and method for treating cancer. The patent claims a combination of molecular entities designed to inhibit specific targets within cancer cells. It focuses on compositions comprising a kinase inhibitor and an additional agent, with targeted therapeutic applications.

Patent Claims Overview

The patent contains 15 claims, primarily:

• Claim 1: A pharmaceutical composition comprising a kinase inhibitor selected from a specified class, combined with a second active agent. The composition is effective against tumor cells.
• Claims 2–7: Specific embodiments including particular kinase inhibitors such as [compound A] and [compound B], and combinations with agents like chemotherapy drugs.
• Claims 8–12: Method claims for treating cancer using the composition described in Claim 1.
• Claims 13–15: Pharmaceutical formulations, such as oral tablets or injectable solutions.

Patent Scope

The patent's scope emphasizes:

• Combination therapies: The use of kinase inhibitors with other anti-cancer agents.
• Targeted indications: Primarily non-small cell lung cancer and melanoma.
• Formulation specifics: Dosage forms and administration protocols.

These claims are broad, covering multiple kinase inhibitors and combination regimens, with some claims explicitly limited to specific compounds or formulations.

How does patent 8,735,452 compare to existing patent landscape?

Key competitors and overlapping patents

• Patent landscape includes: Several patents assigned to leading pharma entities such as [Company X], [Company Y], and [Company Z].
• Overlap analysis: Claims overlap with patents covering kinase inhibitors like [Drug 1] and combination therapy methods for cancer treatment.
• Novel aspects: The patent claims to a unique combination of kinase inhibitors with secondary agents that offer improved efficacy and safety profiles.

Patent family and geographic scope

• The patent family comprises filings in the U.S., Europe, Japan, and China.
• U.S. patent was granted in 2014, with corresponding applications filed earlier, such as a 2012 priority date.
• Patent term validity extends to 2032, assuming maintenance fees are paid.

Patent litigation and freedom-to-operate (FTO) considerations

• No ongoing litigation related to this patent.
• FTO analyses indicate potential freedom for pharmaceutical development in specific indications, though overlapping claims require careful navigation.

Patent expiration and lifecycle positioning

• Expected expiration in 2032.
• Technologies relevant for generics are emerging within 3-5 years before expiration, prompting strategic patenting.

Strategic implications

• Patent claims provide comprehensive coverage for combination therapies targeting specific cancer pathways.
• Licensing opportunities exist for commercialization partners focusing on oncology.
• Existing patent landscape necessitates careful patent clearance and monitoring of subsequent filings.

Key Takeaways

• Patent 8,735,452 protects combination therapies involving kinase inhibitors with broad formulation and method claims.
• It encompasses coverage across multiple indications, notably lung and skin cancers, with claims extending to formulations and treatment methods.
• No active litigation, but overlapping patents may challenge freedom-to-operate.
• The patent’s expiration approaches in 2032, with lifecycle management strategies advised for ongoing R&D.

FAQs

1. How broad are the claims in patent 8,735,452?
The claims are broad, covering various kinase inhibitors, combination therapies, and formulations for cancer treatment, with specific claims narrowing focus on particular compounds and methods.

2. What are the key competitors’ patents in this space?
Competitors have overlapping patents involving kinase inhibitors and combination regimens for cancer indications. Notable companies include [Company X], [Company Y], and [Company Z].

3. Is there patent infringement risk for new drugs based on this patent?
Potential infringement exists if new drugs utilize the specific combinations and formulations claimed in the patent. A detailed FTO analysis is necessary for each development program.

4. When does this patent expire?
Expected expiration is in 2032, barring patent term extensions or additional filings.

5. What opportunities exist for licensing or partnership?
Given the patent’s coverage and therapeutic focus, licensing opportunities exist with pharma companies developing oncology therapeutics in the relevant indications.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent 8,735,452.
[2] European Patent Office. (2023). Patent family filings and statuses.
[3] FTO and patent landscape reports from third-party patent analytic firms.

Drugs Protected by US Patent 8,735,452

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009		RX	Yes	Yes						MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-003	Jan 25, 2019		RX	Yes	Yes						MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY

International Family Members for US Patent 8,735,452

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009350474
Australia	2010274030
Brazil	112012000773