ZUPLENZ Drug Patent Profile

Which patents cover Zuplenz, and when can generic versions of Zuplenz launch?

Zuplenz is a drug marketed by Aquestive and is included in one NDA. There are two patents protecting this drug.

This drug has eighteen patent family members in fourteen countries.

The generic ingredient in ZUPLENZ is ondansetron. There are twenty-eight drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the ondansetron profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zuplenz

A generic version of ZUPLENZ was approved as ondansetron by CHARTWELL MOLECULES on December 26^th, 2006.

Summary for ZUPLENZ

International Patents:	18
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	5
Patent Applications:	4,184
Drug Prices:	Drug price information for ZUPLENZ
What excipients (inactive ingredients) are in ZUPLENZ?	ZUPLENZ excipients list
DailyMed Link:	ZUPLENZ at DailyMed

See drug prices for ZUPLENZ

Recent Clinical Trials for ZUPLENZ

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
M.D. Anderson Cancer Center	Phase 2
Tesaro, Inc.	Phase 2

See all ZUPLENZ clinical trials

US Patents and Regulatory Information for ZUPLENZ

ZUPLENZ is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aquestive	ZUPLENZ	ondansetron	FILM;ORAL	022524-001	Jul 2, 2010		DISCN	Yes	No	9,095,577		Y
Aquestive	ZUPLENZ	ondansetron	FILM;ORAL	022524-002	Jul 2, 2010		DISCN	Yes	No	9,095,577		Y
Aquestive	ZUPLENZ	ondansetron	FILM;ORAL	022524-001	Jul 2, 2010		DISCN	Yes	No	8,580,830		Y
Aquestive	ZUPLENZ	ondansetron	FILM;ORAL	022524-002	Jul 2, 2010		DISCN	Yes	No	8,580,830		Y

International Patents for ZUPLENZ

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2444072	Formes galéniques de film non mucoadhésifs (Non-mucoadhesive film dosage forms)
Canada	2664986	FORMES PHARMACEUTIQUES A BASE DE FILM NON MUCO-ADHESIF (NON-MUCOADHESIVE FILM DOSAGE FORMS)
Mexico	2009003372	FORMAS DE DOSIFICACION DE PELICULA NO MUCOADHESIVA. (NON-MUCOADHESIVE FILM DOSAGE FORMS.)
Australia	2007304425	Non-mucoadhesive film dosage forms
China	105168186	Non-mucoadhesive film dosage forms

ZUPLENZ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zuplenz

Introduction

Zuplenz, an oral soluble film formulation of ondansetron, is a significant player in the market for preventing chemotherapy-induced nausea and vomiting (CINV), radiation-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV). Here, we delve into the market dynamics and financial trajectory of Zuplenz, highlighting its launch, market positioning, and financial performance.

Market Need and Competitive Landscape

Nausea and vomiting are among the most debilitating side effects of cancer treatments and surgeries. The market for antiemetic drugs is substantial, with approximately 20 million prescriptions written for ondansetron in the US in 2015 alone[1].

Zuplenz enters this market with a unique selling proposition: its oral soluble film technology. This innovation offers several benefits over traditional delivery methods, including a non-gritty delivery mechanism, discreet on-the-go usage, and no need to swallow pills during emesis, which can be particularly challenging for patients experiencing nausea and vomiting[1].

Launch and Commercial Strategy

Midatech Pharma acquired Zuplenz in December 2015 and launched it commercially in the US in April 2016. The launch was supported by a significant expansion of Midatech's commercial organization, including additional field sales representation, field sales management, national accounts personnel, and marketing and internal support staff[1].

The commercial strategy included a zero-dollar out-of-pocket patient co-pay program for qualifying individuals, which enhanced patient affordability and compliance. Additionally, Midatech leveraged excellent commercial reimbursement to make Zuplenz more accessible to patients[1].

Market Reception and Benefits

Zuplenz has been well-received by healthcare professionals due to its innovative formulation. Jerilyn Arnold, an Oncology Nurse Specialist, highlighted that Zuplenz avoids the pitfalls associated with other ondansetron products, such as gritty residue and the need for patches, thereby improving patient compliance and efficacy[1].

The product's unique profile and benefits have positioned it strongly in the market. With more than half of the ondansetron market being fulfilled by oral dissolving tablets, Zuplenz's soluble film technology offers a differentiated solution that addresses the limitations of existing products[1].

Financial Performance and Projections

The acquisition and launch of Zuplenz were part of Midatech's broader strategy to expand its oncology supportive care portfolio. The financial performance of Zuplenz has contributed to Midatech's growing revenue stream.

In 2015, Midatech generated consolidated total revenue of £1.38 million, a 763% increase from the previous year, partly due to the acquisition of Zuplenz and other products. The company's net cash outflows for the year were £14.17 million, which included costs associated with the acquisition and listing on NASDAQ[5].

The financial trajectory of Zuplenz is closely tied to Midatech's overall financial health. The company's investment in expanding its commercial organization and marketing efforts for Zuplenz has been significant. However, these investments are expected to yield long-term benefits, including increased market share and revenue growth.

Revenue Streams and Milestones

The revenue generated from Zuplenz is expected to be substantial, given the large market for antiemetic drugs. The acquisition deal for Zuplenz included upfront consideration of $3.75 million in cash, with further cash payments of up to $26 million contingent on achieving certain sales milestones. Although the Board did not expect these milestones to be achieved by the end of 2022, the potential for significant revenue remains[5].

Challenges and Opportunities

Despite the positive market reception, Zuplenz faces challenges in the competitive antiemetic market. The product must continually demonstrate its value proposition to healthcare providers and patients to maintain and grow its market share.

However, the unique formulation and benefits of Zuplenz present significant opportunities. The product's ability to improve patient compliance and reduce the burden of nausea and vomiting can lead to better health outcomes and increased patient satisfaction, further solidifying its position in the market.

Industry Expert Insights

Industry experts have praised Zuplenz for its innovative approach. Dr. Jim Phillips, CEO of Midatech Pharma, emphasized that Zuplenz is a valuable treatment option that leverages Midatech's commercial infrastructure in the US, contributing to the company's growing revenue stream[1].

David Benharris, President of Midatech Pharma US, highlighted the excitement around adding a unique and proven CINV/RINV product to their portfolio, which strengthens their relationships with key healthcare providers[1].

Key Statistics and Data

• Approximately 20 million prescriptions were written for ondansetron in the US in 2015[1].
• More than half of the ondansetron market is fulfilled by oral dissolving tablets[1].
• Midatech generated £1.38 million in consolidated total revenue in 2015, a 763% increase from the previous year[5].
• The acquisition deal for Zuplenz included upfront consideration of $3.75 million in cash, with potential further payments of up to $26 million based on sales milestones[5].

Conclusion

Zuplenz has carved out a niche in the antiemetic market with its innovative oral soluble film technology. The product's launch and commercial strategy have been well-executed, supported by a strong commercial organization and favorable reimbursement policies. While challenges exist in the competitive market, the unique benefits of Zuplenz position it for continued growth and contribution to Midatech's financial trajectory.

Key Takeaways

• Zuplenz is an oral soluble film formulation of ondansetron, offering a unique delivery mechanism.
• The product addresses significant side effects of cancer treatments and surgeries.
• Midatech's commercial strategy includes expanded sales representation and marketing efforts.
• Zuplenz has been well-received by healthcare professionals due to its innovative formulation.
• The financial performance of Zuplenz contributes to Midatech's growing revenue stream.
• The product faces challenges but presents significant opportunities for growth.

Frequently Asked Questions (FAQs)

Q: What is Zuplenz used for? A: Zuplenz is used to prevent chemotherapy-induced nausea and vomiting (CINV), radiation-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV).

Q: What makes Zuplenz unique? A: Zuplenz uses an oral soluble film technology, providing a non-gritty delivery mechanism, discreet on-the-go usage, and no need to swallow pills during emesis.

Q: Who acquired Zuplenz? A: Midatech Pharma acquired Zuplenz in December 2015.

Q: How was the commercial launch of Zuplenz supported? A: The launch was supported by an expanded commercial organization, including additional field sales representation, marketing efforts, and a zero-dollar out-of-pocket patient co-pay program.

Q: What are the potential financial milestones for Zuplenz? A: The acquisition deal included upfront consideration of $3.75 million in cash, with potential further payments of up to $26 million based on sales milestones.

Cited Sources

1. Midatech's Commercial Launch Of Zuplenz (Ondansetron) Oral Soluble Film - Biospace
2. Form 10-Q for Aquestive Therapeutics INC - Aquestive Therapeutics
3. Form 10-K for Cumberland Pharmaceuticals INC - Cumberland Pharmaceuticals
4. ZUPLENZ Label - FDA
5. Annual Report & Accounts 2015 - Midatech Pharma plc