Details for Patent: 7,253,286

Which drugs does patent 7,253,286 protect, and when does it expire?

Patent 7,253,286 protects LENVIMA and is included in one NDA.

Protection for LENVIMA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty-one patent family members in twenty-three countries.

Summary for Patent: 7,253,286

Title:	Nitrogen-containing aromatic derivatives
Abstract:	Compounds represented by the following general formula: ##STR00001## [wherein A.sup.g is an optionally substituted 5- to 14-membered heterocyclic group, etc.; X.sup.g is --O--, --S--, etc.; Y.sup.g is an optionally substituted C.sub.6-14 aryl group, an optionally substituted 5- to 14-membered heterocyclic group, etc.; and T.sup.g1 is a group represented by the following general formula: ##STR00002## (wherein E.sup.g is a single bond or --N(R.sup.g2)--, R.sup.g1 and R.sup.g2 each independently represent a hydrogen atom, an optionally substituted C.sub.1-6 alkyl group, etc. and Z.sup.g represents a C.sub.1-8 alkyl group, a C.sub.3-8 alicyclic hydrocarbon group, a C.sub.6-14 aryl group, etc.)], salts thereof or hydrates of the foregoing.
Inventor(s):	Funahashi; Yasuhiro (Nagoya, JP), Tsuruoka; Akihiko (Tsukuba, JP), Matsukura; Masayuki (Tsukuba, JP), Haneda; Toru (Ushiku, JP), Fukuda; Yoshio (Tsukuba, JP), Kamata; Junichi (Tsukuba, JP), Takahashi; Keiko (Ushiku, JP), Matsushima; Tomohiro (Ushiku, JP), Miyazaki; Kazuki (Tsukuba, JP), Nomoto; Ken-ichi (Tsukuba, JP), Watanabe; Tatsuo (Inzai, JP), Obaishi; Hiroshi (Tsukuba, JP), Yamaguchi; Atsumi (Tsukuba, JP), Suzuki; Sachi (Tsuchiura, JP), Nakamura; Katsuji (Tsukuba, JP), Mimura; Fusayo (Tsukuba, JP), Yamamoto; Yuji (Tsukuba, JP), Matsui; Junji (Toride, JP), Matsui; Kenji (Tsukuba, JP), Yoshiba; Takako (Tsukuba, JP), Suzuki; Yasuyuki (Kagamigahara, JP), Arimoto; Itaru (Tsukuba, JP)
Assignee:	Eisai Co., Ltd (Bunkyo-ku, Tokyo, JP)
Application Number:	10/420,466
Patent Claim Types: see list of patent claims	Compound; Composition;

United States Patent 7,253,286: A Comprehensive Analysis

Introduction

United States Patent 7,253,286, assigned to Eisai R&D Management Co., Ltd., is a significant patent in the pharmaceutical industry, particularly in the field of cancer treatment. This patent covers a class of nitrogen-containing aromatic derivatives, which are crucial in the development of antitumor agents.

Background

The patent was filed on April 18, 2003, as a continuation-in-part of an earlier application, and it was granted on August 7, 2007. It is part of a broader series of patents related to the development of Lenvatinib, a tyrosine kinase inhibitor used in the treatment of various cancers, including thyroid cancer[2].

Inventors and Assignee

The patent lists multiple inventors, including Yasuhiro Funahashi, Akihiko Tsuruoka, Masayuki Matsukura, and others, all affiliated with Eisai R&D Management Co., Ltd. in Japan[1].

Claims and Scope

The patent claims cover a specific class of nitrogen-containing aromatic derivatives, their salts, and methods for their preparation. These compounds are characterized by their structural formulas and are designed to inhibit tyrosine kinases, which are involved in tumor growth and angiogenesis.

Chemical Structure

The patent describes the chemical structure of these derivatives in detail, including the specific substituents and their positions on the aromatic ring. This specificity is crucial for the patent's validity and enforceability[1].

Pharmacological Use

The compounds claimed in this patent are intended for use as antitumor agents. They are particularly effective against various types of cancer by inhibiting the activity of tyrosine kinases, which are key enzymes in the signaling pathways that promote tumor growth and metastasis[1].

Patent Expiration Date

The patent is set to expire on October 24, 2025. This expiration date is critical for generic drug manufacturers, as it marks the point at which they can legally produce and market generic versions of the drug without infringing on the original patent[2][5].

Related Patents and Litigation

The patent landscape surrounding US 7,253,286 includes several related patents, such as US 7,612,208 and US 9,006,256, which also cover aspects of Lenvatinib and its use. These patents have different expiration dates, with some extending as far as August 26, 2035[2][5].

Litigation and Certifications

Generic drug manufacturers seeking to market their versions of Lenvatinib must navigate the complex patent landscape. For instance, Sun Pharmaceutical Industries Limited has filed an Abbreviated New Drug Application (ANDA) with paragraph III and IV certifications regarding the patents, including US 7,253,286. These certifications assert that the generic version does not infringe on the patents or that the patents are invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the generic drug[2].

Impact on Generic Drug Approval

The expiration of US 7,253,286 will significantly impact the approval and marketing of generic versions of Lenvatinib. Until the patent expires, final approval of ANDAs for generic Lenvatinib may not be granted due to the paragraph III certification, which states that the generic version will not be marketed before the patent's expiration[2].

Economic and Market Implications

The expiration of this patent will open the market to generic competition, potentially reducing the cost of Lenvatinib and increasing access to this critical cancer treatment. This shift can have significant economic implications for Eisai R&D Management Co., Ltd. and other stakeholders in the pharmaceutical industry[5].

Conclusion

United States Patent 7,253,286 is a pivotal patent in the development and commercialization of Lenvatinib, a crucial antitumor agent. Understanding its scope, claims, and expiration date is essential for both the original patent holder and generic drug manufacturers. As the patent approaches its expiration date, the pharmaceutical landscape is poised for significant changes.

Key Takeaways

• Patent Scope: Covers nitrogen-containing aromatic derivatives and their salts.
• Pharmacological Use: Antitumor agents, specifically tyrosine kinase inhibitors.
• Expiration Date: October 24, 2025.
• Related Patents: Includes US 7,612,208 and US 9,006,256.
• Litigation and Certifications: Generic manufacturers must navigate complex patent certifications.
• Market Impact: Expiration will open the market to generic competition.

Frequently Asked Questions (FAQs)

Q: What is the primary use of the compounds claimed in US 7,253,286?

A: The compounds are used as antitumor agents, specifically as tyrosine kinase inhibitors.

Q: Who is the assignee of US 7,253,286?

A: The assignee is Eisai R&D Management Co., Ltd.

Q: What is the expiration date of US 7,253,286?

A: The patent is set to expire on October 24, 2025.

Q: How does the expiration of US 7,253,286 affect generic drug approval?

A: The expiration allows for the approval and marketing of generic versions of Lenvatinib without infringing on the original patent.

Q: What are the economic implications of the patent's expiration?

A: The expiration is expected to reduce the cost of Lenvatinib and increase access to the treatment, potentially impacting the market share of Eisai R&D Management Co., Ltd.

Cited Sources

1. United States Patent and Trademark Office, "Quantitative analysis of the profile of tumor vessels may be useful as predictive biomarkers for E7080,” Matsui et al., Abstract i4631, 98th. States Patent Funahashi et al. US007612092B2.
2. U.S. Food & Drug Administration, "Lenvatinib Capsules, 4 mg and 10 mg, to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD) Eisai's Lenvima Capsules, 4 mg and 10 mg."
3. United States Court of Federal Claims, "In the United States Court of Federal Claims - Patent Infringement Case."
4. United States Patent and Trademark Office, "Patent and Trademark Office Notices - USPTO."
5. Drugs.com, "Generic Lenvima Availability - Drugs.com."

Drugs Protected by US Patent 7,253,286

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-001	Feb 13, 2015		RX	Yes	No	7,253,286*PED				Y
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes	7,253,286*PED				Y

Foreign Priority and PCT Information for Patent: 7,253,286

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	P2000-320420	Oct 20, 2000
Japan	P2000-386195	Dec 20, 2000
Japan	P2001-046685	Feb 22, 2001

International Family Members for US Patent 7,253,286

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1415987		CA 2015 00053	Denmark
European Patent Office	1415987		15C0070	France
European Patent Office	1415987		92858	Luxembourg