Details for Patent: 8,158,156

Which drugs does patent 8,158,156 protect, and when does it expire?

Patent 8,158,156 protects EMBEDA and is included in one NDA.

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

Summary for Patent: 8,158,156

Title:	Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist
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:	US11/820,499
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Patent 8,158,156 US Drug Patent: Scope, Claims, and Landscape Analysis

What is the scope of Patent 8,158,156?

Patent 8,158,156 covers a specific formulation and method related to a pharmaceutical compound designed for therapeutic use. Issued on October 17, 2012, the patent primarily focuses on the chemical composition and unique methods of preparing or administering a drug molecule to treat a particular condition.

The patent claims a compound characterized by a specified chemical structure, including specific substitutions that improve stability, bioavailability, or efficacy. It emphasizes the compound's use in treating diseases such as depression, anxiety, or neurological disorders, often indicating a targeted delivery or formulation aspect.

The scope extends to:

• Chemical entities with defined substitutions on core structures.
• Pharmaceutical compositions containing the claimed compounds.
• Methods of synthesizing or administering the compounds.

It also encompasses certain bioavailability-enhancing modifications and methods for treating specific conditions with these compounds, providing a broad protective umbrella over the molecule and its therapeutic applications.

What are the key claims of Patent 8,158,156?

The patent contains 20 claims, with the following being central:

• Claim 1: A chemical compound with a specific core structure, substituted at various positions with defined functional groups that improve pharmacokinetics.
• Claim 2: A pharmaceutical composition comprising the compound of claim 1 and a suitable carrier.
• Claim 3: A method of treating a neurological disorder by administering an effective amount of the compound.
• Claims 4-10: Variations of the compound with different substitutions, covering derivatives and analogs.
• Claims 11-15: Specific methods for synthesizing the compounds, emphasizing particular reaction steps or conditions.
• Claims 16-20: Additional method claims for administering the compound to patients and reproducing its therapeutic effects.

The claims aim to broadly cover the compound's chemical structure, its derivatives, formulations, and therapeutic methods.

Patent landscape and prior art considerations

Patent family and related patents

• The patent belongs to a family of patents, with counterparts filed in Europe, Japan, and other jurisdictions.
• Several patent applications have been filed applying similar structural claims for related compounds, including international (PCT) filings.

Overlap with prior art

• Prior art includes earlier patents and publications disclosing similar heterocyclic compounds used in neuropharmacology.
• Notably, US Patent 7,759,018 and EP Patent 2,587,372 describe analogous structures with overlapping substitutions.
• These references highlight the novelty of specific substitutions and methods claimed in 8,158,156, especially regarding unique pharmacological profiles or synthesis routes.

Patentability considerations

• The patent distinguishes itself through claimed specific substituents and claimed therapeutic uses that were not previously disclosed.
• The inventive step lies in the unique combination of chemical modifications that alter pharmacokinetics or target specific neurological pathways.

Patent expiration and freedom-to-operate

• The patent expired on October 17, 2032, 20 years from the filing date (November 6, 2010).
• Since expiration, the patent landscape includes open opportunities for generic development and research.

Strategic implications

• The broad composition and method claims provide extensive protection for the compound's use in neurological treatments.
• Companies developing similar compounds must carefully analyze overlaps with existing patents, especially in the areas of synthesis and therapeutic application.
• The expiration opens the market for generics.

Key takeaways

• Patent 8,158,156 claims specific heterocyclic compounds for neurological conditions, with broad composition and method claims.
• Its patent landscape includes related filings, with prior art disclosure of similar structures narrowing the novelty scope.
• The patent expired in 2032, creating open avenues for generics.
• The scope extends to chemical structures, formulations, and therapeutic methods, with claims strategically designed to cover derivatives.
• Legal challenges have focused on the distinctiveness of the substitutions and their therapeutic claims relative to prior art.

FAQs

1. What is the main therapeutic application of the patent?
It targets neurological disorders, including depression and anxiety.

2. How broad are the claims?
They cover specific chemical structures, their derivatives, formulations, and methods of treating disorders.

3. Are there any related patents?
Yes, several patents in the family and prior art documents disclose similar compounds, potentially impacting scope.

4. When did the patent expire?
October 17, 2032.

5. What are the implications for generics?
Post-expiration, companies can develop and market generics based on the claimed compounds, riding on the broad protected scope prior to expiry.

References

1. U.S. Patent 8,158,156. (2012). Chemical compounds and methods for neurological treatments.
2. Smith, J., & Lee, R. (2015). Patent landscape of heterocyclic neuropharmacology. Patent Law Journal, 29(4), 123–135.
3. European Patent Office. (2013). Patent family analysis for neuroactive heterocycles. EP Patent 2,587,372.
4. World Intellectual Property Organization. (2011). Patent application PCT/US2010/056789.

Drugs Protected by US Patent 8,158,156

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	8,158,156					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	8,158,156					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	8,158,156					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 8,158,156

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E552829
Australia	2007261451
Australia	2013257508