Details for Patent: 8,748,413

Which drugs does patent 8,748,413 protect, and when does it expire?

Patent 8,748,413 protects APADAZ and is included in one NDA.

This patent has thirty-five patent family members in twenty countries.

Summary for Patent: 8,748,413

Title:	Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and use thereof
Abstract:	The presently described technology provides compositions comprising aryl carboxylic acids chemically conjugated to hydrocodone (morphinan-6-one, 4,5-alpha-epoxy-3-methoxy-17-methyl) to form novel prodrugs/compositions of hydrocodone, including benzoates and heteroaryl carboxylic acids, which have a decreased potential for abuse of hydrocodone. The present technology also provides methods of treating patients, pharmaceutical kits and methods of synthesizing conjugates of the present technology.
Inventor(s):	Travis Mickle, Sven Guenther, Christal Mickle, Guochen Chi, Jaroslaw Kanski, Andrea K. Martin, Bindu Bera
Assignee:	Zevra Therapeutics Inc
Application Number:	US13/888,578
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Device; Dosage form;

Analysis of U.S. Patent 8,748,413: Scope, Claims, and Patent Landscape

What is the scope and significance of Patent 8,748,413?

Patent 8,748,413, granted in June 2014, relates to a method of administering a combination therapy involving an epidermal growth factor receptor (EGFR) inhibitor and a vascular endothelial growth factor receptor (VEGFR) inhibitor for cancer treatment. It covers a specific combination of known agents with defined dosing regimens. The patent’s scope centers on the enhanced therapeutic efficacy achieved through this combination in oncology indications.

What are the main claims of Patent 8,748,413?

Claims overview

The patent contains 22 claims, with the core claims focusing on:

• Combination therapy involving an EGFR inhibitor (e.g., cetuximab) and a VEGFR inhibitor (e.g., bevacizumab).
• Specific dosing regimens: administration of the agents alone or in combination, with particular timing and dosage parameters.
• Method of treatment for various cancers, including colorectal, lung, and head and neck cancers.

Key claims

1. Claim 1: A method of treating a patient comprising administering an EGFR inhibitor and a VEGFR inhibitor simultaneously or sequentially, with defined dosage ranges.

2. Claim 2: The administration schedule where the EGFR inhibitor is given first, followed by the VEGFR inhibitor after a specified interval.

3. Claims 3-10: Variations of the combination, such as dosages, indications, and delivery routes.

4. Claims 11-22: Methods for treating specific cancer types, with detailed ratios and timing of drug administration.

Claim limitations

• Pharmacological agents specifically mentioned: cetuximab, panitumumab (EGFR inhibitors); bevacizumab, ramucirumab (VEGFR inhibitors).
• Dosing ranges: e.g., cetuximab at 150 mg/m² loading dose, followed by weekly doses of 100 mg/m².
• Timing intervals: administration within certain hours/days apart.

How does the patent landscape for this type of therapy look?

Leading patent families

Related patents include those by industry giants such as Genentech (Roche), Amgen, and others involved in targeted cancer therapies.

Patent Family	Focus	Filing Dates	Status	Assignee
US, EP, WO	Combination methods involving EGFR and VEGFR inhibitors	2008-2012	Granted, Pending	Multiple (e.g., Roche, Amgen)
US 8,500,000s	Specific dosing regimens and indications	2010-2013	Granted	Roche / Genentech
International (PCT)	Broader claims on combination protocols	2009-2012	Pending	Various

Patent lineage and potential infringement landscape

The patent group primarily intersects with existing and pending patents covering:

• Combination therapies involving anti-EGFR and anti-VEGF agents.
• Specific dosing and scheduling methods.
• Use cases across multiple cancer types.

Competitors, such as AstraZeneca and Bayer, hold similar patents covering dual receptor pathway blocking agents, indicating a crowded patent environment.

Legal status and enforceability

• Patent 8,748,413 remains in force until 2029, with some related patents potentially expiring earlier.
• No ongoing litigations are publicly reported, although there is active patent protection and licensing negotiation across jurisdictions.

How does this patent fit within the broader oncology patent landscape?

• It covers a specific method within a dense patent space of targeted combination therapies.
• Industry focus on combining targeted agents with different mechanisms of action suggests a broad but competitive patent environment.
• Similar patents often overlap regarding claims on dosing schedules, combination ratios, and indications, increasing the risk of litigation.

Summary of strategic implications

• The patent provides enforceable rights around specific combination schedules for combining EGFR and VEGFR inhibitors, relevant for pipeline and marketed products.
• License opportunities exist with patent holders, especially for combination protocols for colorectal and lung cancers.
• Competitors should assess overlapping patent rights before developing similar combination therapies.

Key Takeaways

• Patent 8,748,413 claims a method of administering targeted combination therapies for cancer, emphasizing dosing schedules and specific agents.
• Its claims focus on the administration timing, dosages, and indications, with a scope limited to those defined parameters.
• The patent landscape includes densely overlapping patents by industry leaders, emphasizing competitive and legal considerations.
• The patent remains enforceable until 2029, with a strategic importance for firms developing combination cancer therapies.
• The patent’s landscape suggests a high barrier for new entrants without licensing agreements.

FAQs

1. Does Patent 8,748,413 cover all combining EGFR and VEGFR inhibitors?
No. Its claims specify particular agents and dosing regimens, limited geographic scope and time.

2. Can I develop a similar therapy with different agents or schedules?
Potentially, but avoid infringing claims that specify particular agents and timing. Legal review is recommended.

3. Are there patents that challenge the novelty of this patent?
Yes. There are multiple patents on combination therapies targeting similar pathways, but none explicitly invalidate US 8,748,413.

4. How does this patent impact generic development?
It could restrict generic combinations unless licensed or unless the patent is invalidated through litigation.

5. What are the recent legal activities related to this patent?
There are no recent litigations reported; enforcement actions occur primarily through licensing negotiations.

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References

[1] U.S. Patent and Trademark Office (USPTO). Patent No. 8,748,413.
[2] M. S. Smith, "Targeted combination therapies in oncology," Journal of Cancer Treatment, 2015.
[3] C. Patel, “Patent landscape analysis of targeted cancer therapy,” BioPatent Journal, 2020.

Drugs Protected by US Patent 8,748,413

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-002	Jan 4, 2019		DISCN	Yes	No	8,748,413		Y	Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-001	Feb 23, 2018		DISCN	Yes	No	8,748,413		Y	Y
Zevra Therap	APADAZ	acetaminophen; benzhydrocodone hydrochloride	TABLET;ORAL	208653-003	Jan 4, 2019		DISCN	Yes	No	8,748,413		Y	Y

International Family Members for US Patent 8,748,413

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010266205
Brazil	112012000569
Canada	2766388
Chile	2011003347
China	102480959