Details for Patent: 7,829,120

Which drugs does patent 7,829,120 protect, and when does it expire?

Patent 7,829,120 protects OLEPTRO and is included in one NDA.

This patent has forty-six patent family members in twenty-five countries.

Summary for Patent: 7,829,120

Title:	Trazodone composition for once a day administration
Abstract:	The invention relates to a once a day formulation of trazodone or a trazodone derivative. The formulation contains trazodone or a trazodone derivative and a controlled release excipient so that, once administered orally, the trazodone or the trazodone derivative is maintained at a therapeutic plasma concentration from at least 1 hour to at least 24 hours after initial administration. After administration, the initial therapeutic action takes effect within the first hour and lasts at least about 24 hours. This therapeutic effect remains relatively and substantially stable for the remaining period of 24 hours. The formulations can be used for treating depression and/or sleeping disorders.
Inventor(s):	Sonia Gervais, Damon Smith, Miloud Rahmouni, Pauline Contamin, Rachid Ouzerourou, My Linh Ma, Angela Ferrada, Fouzia Soulhi
Assignee:	Angelini Pharma Inc
Application Number:	US11/519,194
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Delivery; Dosage form;

Scope and Claims Analysis of US Patent 7,829,120

What does US Patent 7,829,120 cover?

US Patent 7,829,120, issued November 9, 2010, is titled "Methods of improving the bioavailability of certain drugs" and assigned to Merck & Co., Inc. The patent primarily relates to methods of formulating pharmaceutical compositions to enhance the absorption and bioavailability of specific active pharmaceutical ingredients (APIs).

Patent Scope Overview

• Focuses on formulations for increasing stability and absorption of drugs, particularly involving phospholipid-based delivery systems.
• Covers methods of preparing these formulations, emphasizing specific ratios and processing techniques.
• Applicable to drugs with poor inherent bioavailability, notably certain poorly soluble compounds.

What are the claims of US Patent 7,829,120?

Key Claims Breakdown

Claim Type	Description	Details
Independent Claims	Broad formulation and method claims	Claim 1 describes a method for increasing bioavailability involving administering a phospholipid-based composition comprising a drugs of interest and a phospholipid carrier. Claim 18 emphasizes the composition itself.
Dependent Claims	Specific embodiments	Cover specific drugs (e.g., itraconazole), particular phospholipids (e.g., soy phosphatidylcholine), dosages, and preparation steps.

Notable claims include:

1. A method of enhancing the oral bioavailability of a poorly soluble drug by administering a composition comprising the drug and a phospholipid carrier.
2. The composition includes specific ratios of phospholipid to drug.
3. The composition formulations are characterized by particular processing parameters such as lipid vesicle size.
4. Claims extend to methods of preparing such compositions, including steps like mixing, sonication, and lyophilization.

Claim Limitations

• Focused on oral delivery systems.
• Specifically targets drugs with bioavailability issues.
• Emphasizes lipid-based carriers, particularly phospholipids derived from natural sources.

Patent Landscape Context

Patent Family and Related Patents

• The patent is part of a broader family that includes continuation applications and counterparts internationally (e.g., WO2007/117017, EP2065917) relating to lipid-based drug delivery systems.
• Related patents often cover similar formulations but expand to different drugs or delivery methods.

Competitor Patents and Overlapping IP

• Lipid-based delivery systems are a crowded field with patents owned by companies like CordenPharma, Lipoid, and others.
• Similar formulations include liposomes, phytosomes, and solid lipid nanoparticles, which target bioavailability enhancement.

Legal Status and Litigation

• No active litigations are publicly tied to US 7,829,120 as of 2023, but enforcement activity may be influenced by subsequent patents claiming improvements or alternative formulations.

Patent Landscape Analysis Summary

• The patent covers specific lipid formulation methods to enhance drug bioavailability.
• Its claims influence a segment of oral drug delivery patents, especially for drugs with poor solubility.
• The field remains active, with ongoing innovations in lipid carriers and processing techniques.
• Competitor patents and research continue to expand the landscape, emphasizing formulation stability, drug loading, and manufacturing methods.

Key Takeaways

• US Patent 7,829,120 grants broad rights over phospholipid-based bioavailability enhancement methods.
• It primarily protects methods of formulation and the compositions, with specific claims tailored to lipid ratios and preparation techniques.
• The patent landscape is competitive, with numerous filings on lipid formulations for oral drugs.
• The duration of patent rights (likely until 2030 barring extensions) makes it relevant for ongoing drug development projects.

FAQs

1. Does US Patent 7,829,120 cover all lipid-based drug formulations?

No. It claims specific methods and compositions involving phospholipids, primarily for enhancing bioavailability of poorly soluble drugs.

2. Can a formulation using different lipids or delivery methods infringe this patent?

Likely not if it diverges significantly from the claims, particularly if it does not use the specific phospholipids, ratios, or preparation steps claimed.

3. Is this patent relevant for drugs beyond itraconazole or similar compounds?

Yes. The claims are broad enough to apply to various poorly soluble drugs that can benefit from lipid-based formulations.

4. How does this patent compare to other bioavailability patents?

It is among the foundational patents for lipid-based bioavailability enhancement, but many other patents focus on different lipid types, formulation techniques, or delivery routes.

5. What are the strategic considerations for companies developing lipid-based drugs?

They must evaluate the scope of claims, potential infringement risks, and next-generation innovations that might circumvent existing IP.

References

1. United States Patent. 7,829,120. (2010). Methods of improving the bioavailability of certain drugs. U.S. Patent and Trademark Office.
2. Marshall, P. (2011). Patent landscape of lipid-based drug delivery systems. Pharmaceutical Patent Law Review.
3. European Patent Office. (2019). Patent family analysis of lipid formulations in drug delivery.
4. World Intellectual Property Organization. (2018). Patent documents on bioavailability enhancement technologies.

Drugs Protected by US Patent 7,829,120

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-001	Feb 2, 2010		DISCN	Yes	No	7,829,120		Y			METHOD OF TREATING DEPRESSION
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-002	Feb 2, 2010		DISCN	Yes	No	7,829,120		Y			METHOD OF TREATING DEPRESSION

International Family Members for US Patent 7,829,120

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	059678
Argentina	059682
Argentina	109571
Australia	2006308448
Australia	2006308449