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SANCUSO Drug Patent Profile

When do Sancuso patents expire, and what generic alternatives are available?

Sancuso is a drug marketed by Cumberland and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in SANCUSO is granisetron. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the granisetron profile page.

DrugPatentWatch^® Generic Entry Outlook for Sancuso

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 22, 2025. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SANCUSO

International Patents:	40
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	20
Patent Applications:	4,591
Drug Prices:	Drug price information for SANCUSO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SANCUSO
What excipients (inactive ingredients) are in SANCUSO?	SANCUSO excipients list
DailyMed Link:	SANCUSO at DailyMed

See drug prices for SANCUSO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SANCUSO

Constraining patent/regulatory exclusivity:

7,608,282

NDA:

022198

Dosage:

FILM, EXTENDED RELEASE;TRANSDERMAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SANCUSO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Solasia Pharma K.K.	Phase 1
Kyowa Kirin, Inc.	Phase 1
PPD	Phase 1

See all SANCUSO clinical trials

Pharmacology for SANCUSO

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

Paragraph IV (Patent) Challenges for SANCUSO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SANCUSO	Transdermal System	granisetron	3.1 mg/24 hrs	022198	1	2015-10-09

US Patents and Regulatory Information for SANCUSO

SANCUSO is protected by one US patents.

This potential generic entry date is based on patent 7,608,282.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cumberland	SANCUSO	granisetron	FILM, EXTENDED RELEASE;TRANSDERMAL	022198-001	Sep 12, 2008		RX	Yes	Yes	7,608,282		Y

EU/EMA Drug Approvals for SANCUSO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Kyowa Kirin Holdings B.V.	Sancuso	granisetron	EMEA/H/C/002296 Prevention of nausea and vomiting in patients receiving moderately or highly emetogenic chemotherapy, with or without cisplatin, for up to five consecutive days.Sancuso may be used in patients receiving their first chemotherapy regimen or in patients who have previously received chemotherapy.	Authorised	no	no	no	2012-04-20

International Patents for SANCUSO

See the table below for patents covering SANCUSO around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1589956
Georgia, Republic of	P20084390	TRANSDERMAL GRANISETRON
Germany	602004007888
Serbia	51696	TRANSDERMALNI GRANISETRON (TRANSDERMAL GRANISETRON)
Iceland	7997	Granisetron lyfjaplástur
South Korea	20050116365	TRANSDERMAL GRANISETRON

SANCUSO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SANCUSO

Introduction

SANCUSO, a granisetron transdermal patch, is an FDA-approved oncology-supportive care medicine designed to prevent nausea and vomiting in patients undergoing certain types of chemotherapy. Here, we will delve into the market dynamics and financial trajectory of SANCUSO, particularly since its acquisition by Cumberland Pharmaceuticals.

Acquisition and Transition

In January 2022, Cumberland Pharmaceuticals Inc. acquired the U.S. rights to SANCUSO from Kyowa Kirin North America. This acquisition marked a significant expansion of Cumberland's product portfolio, especially in the oncology segment. The financial terms included a $13.5 million payment upon closing, up to $3.5 million in milestones, and tiered royalties of up to 10% on U.S. net product sales[4].

Market Need and Positioning

SANCUSO addresses a critical need in oncology care by providing a simple, easy-to-apply preventative solution for nausea and vomiting associated with chemotherapy. Unlike oral treatments that must be taken multiple times a day, SANCUSO offers a convenient patch that does not require swallowing pills, which can be challenging for patients experiencing nausea. This unique value proposition positions SANCUSO as a valuable supportive therapeutic solution in the oncology market[4].

Revenue Performance

Since the acquisition, SANCUSO has contributed significantly to Cumberland Pharmaceuticals' revenue. In the second quarter of 2024, SANCUSO generated $2.2 million in net revenue, contributing to the company's overall net revenue of $9.9 million. On a year-to-date basis, SANCUSO revenues totaled $4 million, indicating a steady and growing contribution to the company's financial performance[5].

Financial Impact on Cumberland Pharmaceuticals

The addition of SANCUSO to Cumberland's product portfolio has positively impacted the company's financials. The acquisition added $19 million in new assets, including $4 million in inventory and $14 million in intangible assets. The estimated value of these assets was $11.6 million at the end of the second quarter of 2024. The financial terms, including the initial payment and ongoing royalties, have been integrated into Cumberland's financial reporting, reflecting the brand's growing importance[5].

Operating Expenses and Adjusted Earnings

The integration of SANCUSO has also influenced Cumberland's operating expenses. Total operating expenses for the second quarter of 2024 were $10.9 million, with year-to-date expenses totaling $21.2 million. Despite a net loss of $1.1 million for the quarter, adjusted earnings showed a $0.8 million improvement over the prior-year period, partly due to the positive impact of SANCUSO and another acquired product, Vibativ[5].

Balance Sheet and Cash Flow

As of June 30, 2024, Cumberland's balance sheet reflected the acquisition's impact. The company had $78.5 million in assets, $52.5 million in liabilities, and $26.3 million in shareholders' equity. The cash and cash equivalents at the end of the period were $17.3 million. The acquisition and subsequent sales of SANCUSO have contributed to Cumberland's cash flow, with the company anticipating double-digit revenue growth and positive cash flow from operations in 2024[1][5].

Market Expansion and Future Prospects

Cumberland Pharmaceuticals has been expanding its oncology sales division to deliver SANCUSO to more cancer patients. This expansion, combined with ongoing support for international partners in registering Cumberland brands, including SANCUSO, in other markets like China, indicates a strong potential for future growth. The company's optimism about its future, as expressed by its CEO, underscores the strategic importance of SANCUSO in its product portfolio[2][3].

Regulatory and Market Environment

The passage of the federal NOPAIN Act in early 2023 is expected to provide favorable reimbursement for non-opioid products like SANCUSO, although the Act's implementation is scheduled for 2025. This regulatory environment could further enhance the market dynamics and financial trajectory of SANCUSO by making it more attractive to healthcare providers and patients[3].

Key Takeaways

• Acquisition Impact: SANCUSO's acquisition has significantly expanded Cumberland Pharmaceuticals' oncology portfolio and contributed to its revenue growth.
• Revenue Contribution: SANCUSO generated $2.2 million in net revenue in Q2 2024 and $4 million year-to-date, indicating a steady contribution.
• Financial Performance: The brand has positively impacted Cumberland's adjusted earnings and overall financial performance.
• Market Need: SANCUSO addresses a critical need in oncology care with its unique delivery mechanism.
• Future Prospects: The brand is expected to continue growing, especially with the expansion of Cumberland's oncology sales division and favorable regulatory changes.

FAQs

Q: What is SANCUSO, and how does it work? A: SANCUSO is an FDA-approved granisetron transdermal patch designed to prevent nausea and vomiting in patients undergoing certain types of chemotherapy. It offers a convenient, easy-to-apply solution that does not require swallowing pills.

Q: Who acquired SANCUSO, and when? A: Cumberland Pharmaceuticals Inc. acquired the U.S. rights to SANCUSO from Kyowa Kirin North America in January 2022.

Q: What were the financial terms of the acquisition? A: The acquisition included a $13.5 million payment upon closing, up to $3.5 million in milestones, and tiered royalties of up to 10% on U.S. net product sales.

Q: How has SANCUSO impacted Cumberland Pharmaceuticals' revenue? A: SANCUSO generated $2.2 million in net revenue in Q2 2024 and $4 million year-to-date, contributing significantly to Cumberland's overall revenue growth.

Q: What are the future prospects for SANCUSO? A: With the expansion of Cumberland's oncology sales division and favorable regulatory changes such as the NOPAIN Act, SANCUSO is expected to continue growing and contributing positively to Cumberland's financial performance.

Sources

1. Cumberland Pharmaceuticals Reports 16% Sequential Revenue Growth in Second Quarter 2024 - Cumberland Pharmaceuticals Inc.
2. COMPANY UPDATE - Cumberland Pharmaceuticals Inc.
3. Cumberland Pharmaceuticals Reports Annual 2023 Financial Results - PR Newswire
4. Cumberland Pharmaceuticals Acquires Sancuso® From Kyowa Kirin North America - Investing.com
5. Earnings call: Cumberland Pharmaceuticals sees robust Q2 growth - Investing.com