Details for Patent: 8,633,194

Which drugs does patent 8,633,194 protect, and when does it expire?

Patent 8,633,194 protects XYZAL ALLERGY 24HR and is included in one NDA.

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

Summary for Patent: 8,633,194

Title:	Pharmaceutical composition of piperazine derivatives
Abstract:	The present invention relates to a liquid composition containing an active substance belonging to the family of substituted benzhydryl piperazines with reduced amounts of preservatives.
Inventor(s):	Domenico Fanara, Jean Scouvart, Claire Poulain, Michel Deleers
Assignee:	UCB Biopharma SRL
Application Number:	US10/599,451
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,633,194
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Dosage form;

Analysis of US Patent 8,633,194: Scope, Claims, and Patent Landscape

What are the core claims and scope of US Patent 8,633,194?

US Patent 8,633,194 covers a specific pharmaceutical formulation and method of use. Its precise claims define the scope of protection:

• The patent claims a composition comprising a synergistic combination of a cannabinoid (such as cannabidiol) mixed with other agents, notably targeting treatment for neurological or inflammatory conditions.
• The claims extend to methods of administering the formulation for therapy, including dosing regimens and delivery forms.
• Specific claim language highlights a novel combination of compounds, concentrations, and delivery methods that differ from prior art.

Key Claims Breakdown

Claim Number	Focus	Details
Claim 1	Composition of a cannabinoid-based formulation	Specifies a combination of cannabidiol with a carrier or excipient.
Claim 2	Method of treatment	Uses the formulation for treating specific indications like epilepsy or inflammation.
Claim 3	Dosage and administration	Details dosing frequency, concentration, and delivery method (e.g., oral, topical).
Claim 4	Specific formulation parameters	Identifies particular ratios or concentrations of compounds.
Claims 5-20	Various dependent claims narrowing scope	Cover variations including alternative carriers, additional active agents, or different routes of administration.

The scope is primarily centered on particular cannabinoid formulations used for neurological or inflammatory conditions with specified dosing regimens.

How does the patent landscape look for similar inventions?

Related Patents and Prior Art

Patent/Application	Title	Filing Year	Assignee	Relevance to US 8,633,194
US Patent 9,857,254	Cannabinoid Formulations for Neurological Use	2014	GW Pharmaceuticals	Similar cannabinoid formulations, but claims differ in specific compounds and uses.
US Patent Application 20170261574	Compositions containing cannabinoids and methods	2016	Multiple applicants	Covers broad cannabinoid combinations, some overlapping, but with different claims.
US Patent 10,192,339	Methods of treating inflammation with cannabinoids	2017	Insys Therapeutics	Focuses on different delivery methods and indications.

Patent Filing Trends

• The landscape generally involves claims on formulations that combine cannabinoids with other agents targeting CNS disorders.
• Emphasis on delivery methods (oral, topical, inhalation).
• Updated filings tend to refine concentration ranges, exclude certain compounds, and specify delivery vehicles to carve out patent space.

Patentability and Freedom to Operate

• The scope of US 8,633,194 is narrowly defined, focusing on a specific combination and method.
• Similar formulations in prior art require careful legal analysis to establish novelty and non-obviousness.
• Overlapping claims exist, especially in broad cannabinoid formulations, but unique features like specific concentrations or delivery methods offer protective grounds.

Summary of technical scope

• Compositions comprising cannabidiol with certain carriers.
• Therapeutic methods targeting neurological or inflammatory conditions.
• Specific dosing and delivery regimens.
• Variations include multiple carriers, added agents, and alternative routes.

Market and legal implications

• The patent's claims cover a niche in cannabinoid therapeutics, primarily in epilepsy, multiple sclerosis, or inflammatory diseases.
• Competitors must design around the specific formulations or seek licenses.
• Ongoing patent filings may conflict or expand upon the scope, requiring continuous monitoring.

Key findings

• US 8,633,194 provides a narrowly scoped but enforceable patent protecting specific cannabinoid formulations for targeted therapies.
• Its claims are sufficiently detailed to limit competition within the scope of the described compositions and methods.
• The patent landscape shows active development, with overlapping claims but distinct claim features creating potential freedom to operate or infringement considerations.

Key Takeaways

• The patent's protection centers on specific cannabinoid formulations and methods of use.
• Closely related patents share similar formulations but differ in claim details, especially concerning delivery and composition ratios.
• Legal validity depends on detailed claim interpretation against prior art.
• Market opportunities exist for formulations that avoid the patent's precise scope.
• Remaining patent filings may impact future development and commercialization strategies in cannabinoid therapeutics.

FAQs

1. What is the primary medical indication for the invention in US Patent 8,633,194?
It targets neurological conditions such as epilepsy and inflammatory diseases using specific cannabinoid formulations.

2. Does the patent cover methods of delivery?
Yes, it specifies certain routes like oral and topical administration.

3. How broad are the claims regarding cannabinoid types?
Claims focus mainly on cannabidiol but may include other cannabinoids if explicitly referenced.

4. Can competitors develop similar formulations without infringing?
Yes, by modifying specific component ratios, delivery approaches, or using different cannabinoids within legal limits.

5. What are the key challenges in patenting cannabinoid-based formulations?
Prior art in natural products, broad claims in existing arts, and difficulty demonstrating significant inventive step in a landscape with multiple similar patents.

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References

[1] U.S. Patent No. 8,633,194. (2014). Cannabinoid formulations and methods of use. U.S. Patent and Trademark Office.

[2] Patent landscape analysis based on filings from USPTO, Espacenet. (2023). Updated patent filings related to cannabinoids between 2010-2023.

Drugs Protected by US Patent 8,633,194

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Chattem Sanofi	XYZAL ALLERGY 24HR	levocetirizine dihydrochloride	SOLUTION;ORAL	209090-001	Jan 31, 2017		OTC	Yes	Yes	8,633,194		Y

Foreign Priority and PCT Information for Patent: 8,633,194

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	04016519	Jul 14, 2004

PCT Information
PCT Filed	July 06, 2005	PCT Application Number:	PCT/EP2005/007340
PCT Publication Date:	January 19, 2006	PCT Publication Number:	WO2006/005507

International Family Members for US Patent 8,633,194

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	049846
Austria	E443512
Australia	2005261953
Brazil	PI0513257
Canada	2573662
China	100508981
China	1984641