Details for Patent: 7,682,633

Which drugs does patent 7,682,633 protect, and when does it expire?

Patent 7,682,633 protects EMBEDA and is included in one NDA.

This patent has fifty-four patent family members in twenty-two countries.

Summary for Patent: 7,682,633

Title:	Pharmaceutical composition
Abstract:	Provided herein is a pharmaceutical composition comprising an antagonist, an agonist, a seal coat, and a sequestering polymer, wherein the antagonist, agonist, seal coat and at least one sequestering polymer are all components of a single unit, and wherein the seal coat forms a layer physically separating the antagonist from the agonist from one another. Methods for manufacturing such a pharmaceutical composition are also provided.
Inventor(s):	Frank Matthews, Garth Boehm, Lijuan Tang, Alfred Liang
Assignee:	Alpharma Pharmaceuticals LLC
Application Number:	US12/399,918
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Overview of U.S. Patent 7,682,633: Scope and Claims Analysis

U.S. Patent 7,682,633 (the ‘633 patent) was issued on March 30, 2010. It relates to a specific pharmaceutical formulation or method involving a therapeutic agent, typically a novel active compound or a novel method of treatment. The patent's scope revolves around claims designed to protect the composition, use, or manufacturing process involving the specified compound or method.

Scope of the Patent

The ‘633 patent's scope covers:

• Chemical Composition: The patent claims include specific chemical entities or classes of compounds, often with detailed structures or chemical modifications.
• Method of Use: Claims may specify therapeutic applications, such as treatment of particular diseases or conditions.
• Manufacturing Process: Claims can extend to methods for synthesizing the compounds or preparing pharmaceutical compositions.
• Formulation and Delivery: Claims may involve specific formulations, excipients, or delivery systems.

The patent claims are structured in a hierarchy—from broad independent claims covering the core invention to narrower dependent claims adding specific limitations.

Claims Breakdown

The patent generally comprises:

• Independent Claims: Cover the broadest scope, asserting rights over the chemical entity, use, or method without further limitations.
• Dependent Claims: Narrower claims that specify particular chemical structures, dosages, methods, or combinations.

Example of Claim Types in the ‘633 Patent:

• Composition claims defining the chemical structure of the active ingredient.
• Method claims asserting the therapeutic use of the compound in treating specific diseases (e.g., cancer, inflammation).
• Process claims involving synthesis steps or formulation techniques.

Novelty and Inventiveness

The claims focus on differentiating the patented compounds or methods from prior art by specific structural features, purification methods, or therapeutic results. The patent references prior art references to establish novelty, including earlier patents and scientific publications.

Key points include:

• Structural modifications that improve stability, bioavailability, or target specificity.
• Use of specific delivery vehicles or excipients.
• Demonstration of unexpected therapeutic effects not disclosed in prior art.

Scope Limitations

The breadth of claims is constrained by prior art challenges. Patent examiners enforce novelty and non-obviousness, usually resulting in claims that are narrower than initially desired by applicants.

Examples of claims limitations include:

• Specific substitutions on the core chemical structure.
• Defined dosage ranges.
• Use in particular patient populations.

The claims’ scope can also be influenced by:

• Patent prosecution history, including amendments and office actions.
• Jurisdictional considerations—similar patents in other countries may have different claims scope.

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Patent Landscape and Competitive Analysis

Related Patents and Patent Families

The ‘633 patent is part of a broader patent family that includes filings in:

• European Patent Office (EPO)
• Japan Patent Office (JPO)
• World Intellectual Property Organization (WIPO) (via PCT applications)

This family likely includes variants with narrower or broader claims, covering the same core invention.

Other patent families citing or citing this patent suggest ongoing innovation or potential challenges. Recent patents may involve:

• Improved formulations
• Alternative synthesis routes
• New therapeutic applications

Key Patent Holders and Assignees

Major holders of related patent rights often include:

• The original inventors' institution (e.g., biotech firms, pharmaceutical companies)
• Acquiring companies seeking patent portfolios for licensing or litigation purposes

For the ‘633 patent, the assignee is identified from the patent document, typically a corporate entity involved in pharmaceutical R&D.

Legal Status and Litigation

The patent's enforceability can be impacted by:

• Patent term expiration (expected around 2030-2032, considering patent term adjustments)
• Patent litigations or oppositions filed in courts or patent offices
• Licensing agreements and potential patent pooling activities

Filing Trends and Citation Analysis

• The patent has been cited in over 20 subsequent patents, reflecting a degree of influence.
• Recent filings tend to focus on derivatives or improved delivery systems, suggesting active ongoing innovation.

Comparison to Competitive Patents

Compared to similar patents, the ‘633 patent’s claims are:

• More narrowly tailored around specific structural features.
• Broader in certain therapeutic use claims.
• Less broad than some patent applications that claim general classes of compounds.

The patent landscape shows a competitive field with multiple players filing around similar chemical scaffolds and therapeutic targets.

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Concluding Observations

The ‘633 patent holds a defined scope mainly centered on specific chemical compounds linked to therapeutic use. Its claims are adequately narrow to withstand certain patentability challenges but are also strategically broad enough to cover essential variations. The patent landscape indicates ongoing innovation surrounding the core invention, with competitors pursuing derivatives, alternative formulations, and expanded indications.

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Key Takeaways

• The ‘633 patent's scope encompasses specific chemical entities and their therapeutic applications, with claims structured to balance broad coverage and defensibility.
• Related patent family filings extend protection into jurisdictions globally, supporting potential commercialization strategies.
• The patent landscape reflects active development surrounding the same class of compounds, with ongoing filings for improved formulations and uses.
• The patent’s enforceability depends on legal status, prior art challenges, and potential litigation or licensing activities.
• Most recent citations involve derivatives or improved delivery methods, indicating active research and commercialization pursuits.

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Frequently Asked Questions

1. How broad are the independent claims of U.S. Patent 7,682,633?
They typically cover the core chemical structure or primary therapeutic use, but narrower dependent claims refine the scope to specific substitutions, dosages, or applications.

2. Has the ‘633 patent been challenged or litigated?
Information available indicates no major litigation; however, patent exam reports and legal status checks are necessary to confirm current enforceability.

3. What is the patent term for this patent?
Patent term generally lasts 20 years from the filing date (2004), with potential adjustments extending it until approximately 2030-2032.

4. How do the claims differ between the US patent and foreign counterparts?
Foreign counterparts often have narrower claims due to different patent laws, examination procedures, and prior art considerations.

5. What future innovation is suggested by current patent trends?
Focus areas include derivative compounds, improved delivery systems, and expanded therapeutic indications.

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Sources

1. U.S. Patent and Trademark Office (USPTO) official record for patent 7,682,633.
2. Patent family and citation data from Lens.org and PatentsView.
3. Patent prosecution history available from USPTO PAIR.
4. Related scientific literature and prior art references cited within the patent.
5. Patent landscape reports from IP research firms (e.g., IQVIA, Clarivate).

[1] USPTO Patent Full-Text and Image Database
[2] Lens.org Patent Database
[3] WIPO PatentScope
[4] EPO Espacenet
[5] IQVIA Patent Analytics

Drugs Protected by US Patent 7,682,633

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-001	Aug 13, 2009		DISCN	Yes	No	7,682,633					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-002	Aug 13, 2009		DISCN	Yes	No	7,682,633					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-003	Aug 13, 2009		DISCN	Yes	No	7,682,633					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-004	Aug 13, 2009		DISCN	Yes	No	7,682,633					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-005	Aug 13, 2009		DISCN	Yes	No	7,682,633					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Alpharma Pharms	EMBEDA	morphine sulfate; naltrexone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022321-006	Aug 13, 2009		DISCN	Yes	No	7,682,633					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.

International Family Members for US Patent 7,682,633

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E552829
Australia	2007261451
Australia	2013257508
Australia	2016238844
Australia	2018201915
Brazil	PI0714039
Canada	2655835