Details for Patent: 7,608,282

Which drugs does patent 7,608,282 protect, and when does it expire?

Patent 7,608,282 protects SANCUSO and is included in one NDA.

This patent has forty patent family members in thirty-one countries.

Summary for Patent: 7,608,282

Title:	Transdermal granisetron
Abstract:	Adhesive patches for the transdermal administration of granisetron, comprise an acrylic adhesive containing non-acidic nucleophilic moieties which substantially increase flux of granisetron across the skin.
Inventor(s):	Altenschopfer; Peter (Ortenburg, DE), Watkinson; Adam Charles (Victoria, AU)
Assignee:	Strakan International Limited (Hamilton, BM)
Application Number:	10/544,259
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,608,282
Patent Claim Types: see list of patent claims	Compound; Use;

United States Patent 7,608,282: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 7,608,282, titled "Transdermal granisetron," is a significant patent in the pharmaceutical industry, particularly in the field of transdermal drug delivery. This patent, granted to the manufacturer of Sancuso, a brand name for granisetron, provides exclusive rights for the transdermal administration of this medication. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Overview of Granisetron

Granisetron is a 5HT3 antagonist used primarily to treat nausea and vomiting associated with cancer chemotherapy and postoperative care[4]. The transdermal formulation of granisetron, as described in the patent, offers a convenient and continuous delivery method, which is crucial for managing these symptoms effectively.

Patent Scope

The patent scope of US7608282B2 is defined by its claims, which outline the specific aspects of the invention that are protected. Here are some key points:

Claims

• The patent includes claims for adhesive patches designed for the transdermal administration of granisetron. These patches contain an acrylic adhesive with non-acidic nucleophilic moieties, which enhance the stability and delivery of the drug[1][5].
• The claims also cover the method of treatment using these patches, including the prevention and treatment of vomiting, particularly postoperative nausea and vomiting (PONV) and chemotherapy-induced nausea and vomiting (CINV)[1].

Independent Claims

• Independent claims are crucial as they define the broadest scope of the invention. For US7608282B2, these claims focus on the composition of the adhesive patches, the method of manufacturing, and the therapeutic uses of the transdermal granisetron[1].

Dependent Claims

• Dependent claims further specify the invention by adding additional limitations to the independent claims. These may include specific concentrations of granisetron, the type of adhesive used, and other detailed aspects of the patch formulation[1].

Patent Claims Analysis

Claim Length and Count

• Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. For US7608282B2, the claims are detailed and specific, indicating a well-defined scope that protects the unique aspects of the transdermal granisetron formulation[3].

Claim Clarity

• Claim clarity is another critical factor in patent quality. The claims in US7608282B2 are clear and specific, reducing the likelihood of disputes over the scope of the invention. This clarity is essential for ensuring that the patent holder's rights are well-defined and enforceable[3].

Patent Landscape

Exclusivity and Generic Availability

• As of the last update, there is no therapeutically equivalent generic version of Sancuso available in the United States. The patent's exclusivity period, combined with FDA exclusivity, has ensured that the manufacturer retains sole marketing rights until the patent expires on January 22, 2025[2].

Related Patents

• The patent landscape for granisetron includes several related patents that cover different aspects of its formulation, manufacturing, and therapeutic uses. However, US7608282B2 is unique in its focus on transdermal delivery, which sets it apart from other formulations like oral tablets or intravenous solutions[2].

Therapeutic Applications

Chemotherapy-Induced Nausea and Vomiting (CINV)

• The transdermal granisetron patch is particularly effective in managing CINV, a common side effect of cancer chemotherapy. The continuous delivery of the drug ensures consistent therapeutic levels, reducing the incidence of nausea and vomiting[4].

Postoperative Nausea and Vomiting (PONV)

• The patch is also indicated for the prevention and treatment of PONV, providing a convenient alternative to oral or intravenous antiemetics. This is especially beneficial in postoperative settings where oral medication may not be feasible[1].

Manufacturing and Composition

Adhesive Formulation

• The patent describes an acrylic adhesive containing non-acidic nucleophilic moieties, which enhances the stability and delivery of granisetron. This formulation is critical for the effective transdermal delivery of the drug[1].

Patch Design

• The design of the patch, including the backing layer, adhesive layer, and release liner, is also detailed in the patent. This ensures that the patch adheres well to the skin and delivers the drug consistently over the specified period[1].

Regulatory and Legal Aspects

FDA Approval

• Sancuso, the brand name for the transdermal granisetron patch, was approved by the FDA on September 12, 2008. This approval is a significant milestone, as it validates the safety and efficacy of the transdermal formulation[2].

Patent Expiration

• The patent is set to expire on January 22, 2025. After this date, generic versions of the transdermal granisetron patch may be developed and approved, subject to demonstrating bioequivalence to the Reference Listed Drug (RLD)[2].

Conclusion

United States Patent 7,608,282 is a pivotal patent in the field of transdermal drug delivery, particularly for the management of nausea and vomiting. The patent's scope, defined by its detailed claims, protects the unique formulation and therapeutic uses of transdermal granisetron. As the patent approaches its expiration date, it is likely that the landscape for this medication will evolve, potentially leading to the availability of generic alternatives.

Key Takeaways

• Transdermal Delivery: The patent covers the transdermal administration of granisetron, providing a continuous and convenient delivery method.
• Adhesive Formulation: The use of an acrylic adhesive with non-acidic nucleophilic moieties is crucial for the stability and delivery of the drug.
• Therapeutic Applications: The patch is effective in managing CINV and PONV.
• Patent Exclusivity: The patent expires on January 22, 2025, after which generic versions may be developed.
• Regulatory Approval: Sancuso was approved by the FDA on September 12, 2008.

FAQs

What is the primary use of the transdermal granisetron patch?

The primary use of the transdermal granisetron patch is to treat nausea and vomiting associated with cancer chemotherapy and postoperative care.

Is there a generic version of Sancuso available?

As of the last update, there is no therapeutically equivalent generic version of Sancuso available in the United States.

When does the patent for US7608282B2 expire?

The patent for US7608282B2 is set to expire on January 22, 2025.

What makes the adhesive formulation in US7608282B2 unique?

The adhesive formulation in US7608282B2 is unique due to the use of an acrylic adhesive containing non-acidic nucleophilic moieties, which enhances the stability and delivery of granisetron.

How does the transdermal granisetron patch compare to other antiemetic formulations?

The transdermal granisetron patch offers a continuous and convenient delivery method, which is particularly beneficial in settings where oral or intravenous administration may not be feasible.

Sources

1. US7608282B2 - Transdermal granisetron - Google Patents
2. Generic Sancuso Availability - Drugs.com
3. Patent Claims and Patent Scope - Hoover Institution
4. Granisetron: Uses, Interactions, Mechanism of Action - DrugBank
5. US7608282B2 - Transdermal granisetron - Google Patents

Drugs Protected by US Patent 7,608,282

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cumberland	SANCUSO	granisetron	FILM, EXTENDED RELEASE;TRANSDERMAL	022198-001	Sep 12, 2008		RX	Yes	Yes			Y			USE OF GRANISETRON TRANSDERMAL SYSTEM TO TREAT/PREVENT CHEMOTHERAPY INDUCED NAUSEA AND VOMITING

Foreign Priority and PCT Information for Patent: 7,608,282

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0302662.2	Feb 05, 2003

PCT Information
PCT Filed	February 05, 2004	PCT Application Number:	PCT/GB2004/000403
PCT Publication Date:	August 19, 2004	PCT Publication Number:	WO2004/069141

International Family Members for US Patent 7,608,282

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	368454
Australia	2004210181
Brazil	PI0407280
Canada	2515094
China	102416009
China	102526043