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TALICIA Drug Patent Profile

Which patents cover Talicia, and what generic alternatives are available?

Talicia is a drug marketed by Redhill and is included in one NDA. There are seven patents protecting this drug.

This drug has thirty patent family members in twenty-five countries.

The generic ingredient in TALICIA is amoxicillin; omeprazole magnesium; rifabutin. There are forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; omeprazole magnesium; rifabutin profile page.

DrugPatentWatch^® Generic Entry Outlook for Talicia

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 1, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TALICIA

International Patents:	30
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for TALICIA
What excipients (inactive ingredients) are in TALICIA?	TALICIA excipients list
DailyMed Link:	TALICIA at DailyMed

See drug prices for TALICIA

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

213004

Dosage:

CAPSULE, DELAYED RELEASE;ORAL

^*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.

Pharmacology for TALICIA

Drug Class	Penicillin-class Antibacterial Proton Pump Inhibitor Rifamycin Antimycobacterial
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

US Patents and Regulatory Information for TALICIA

TALICIA is protected by seven US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

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
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes			Y
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes			Y
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes			Y
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes			Y

International Patents for TALICIA

When does loss-of-exclusivity occur for TALICIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Croatia

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Philippines

Poland

Portugal

Russian Federation

Singapore

Slovenia

South Korea

Spain

Ukraine

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

See the table below for additional patents covering TALICIA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2016508516	ピロリ菌治療用医薬組成物
European Patent Office	2956149	COMPOSITIONS PHARMACEUTIQUES DESTINÉES AU TRAITEMENT D'HELICOBACTER PYLORI (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF HELICOBACTER PYLORI)
Mexico	368536	COMPOSICION FARMACEUTICA PARA EL TRATAMIENTO DE HELICOBACTER PYLORI. (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF HELICOBACTER PYLORI.)
Croatia	P20191559
Portugal	2956149
Australia	2014216373	Pharmaceutical compositions for the treatment of Helicobacter pylori

TALICIA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Talicia

Introduction

Talicia, a groundbreaking drug developed by RedHill Biopharma, has been making significant waves in the pharmaceutical industry, particularly in the treatment of H. pylori infections. Here, we delve into the market dynamics and financial trajectory of Talicia, highlighting its growth, market position, and the strategic moves that have shaped its success.

Market Position and Growth

Prescription Growth and Market Leadership

Talicia has demonstrated impressive growth since its approval by the U.S. FDA in November 2019. It has become the most prescribed branded agent by U.S. gastroenterologists and is on track to become the most prescribed branded H. pylori therapy in the U.S.[1][2][4].

• In Q4 2022, Talicia saw a 26% increase in prescriptions compared to Q4 2021, contributing to a 57% year-over-year growth in prescriptions[1].
• This upward trajectory is a testament to its efficacy and the growing trust among healthcare professionals.

Coverage and Accessibility

Talicia's market penetration is further enhanced by its extensive coverage:

• As of December 31, 2022, Talicia coverage stood at more than 202 million American lives, significantly improving patient access to this treatment[1].

Clinical Efficacy and Differentiation

Addressing Antibiotic Resistance

Talicia is designed to address the high resistance of H. pylori bacteria to traditional antibiotics, particularly clarithromycin. It is the only low-dose rifabutin-based therapy approved for this indication, showing an 84% eradication rate in the intent-to-treat group in its pivotal Phase 3 study, compared to 58% for the active comparator arm[4].

• The minimal to zero resistance to rifabutin observed in clinical trials underscores its effectiveness in a market where treatment failures are common due to antibiotic resistance[4].

Regulatory Exclusivity

Extended Market Exclusivity

Talicia benefits from significant regulatory exclusivity:

• It is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation, providing a strong competitive advantage[4].

Financial Performance

Revenue and Prescription Growth

The financial performance of Talicia is closely tied to its prescription growth:

• Despite increased gross-to-net allowances that reduced net revenues, Talicia delivered year-over-year prescription growth of 57%, indicating strong market demand[1].
• Net revenues for Talicia, while affected by gross-to-net allowances, reflect the drug's growing market share and prescription volume[1].

Cost and Revenue Dynamics

• In the fourth quarter of 2022, RedHill Biopharma reported net revenues of $8.6 million, down from $19.3 million in the same period of 2021, primarily due to increased gross-to-net allowances[1].
• For the full year 2022, net revenues were $33.3 million, compared to $49.4 million in 2021, with the decrease attributed to cost reduction measures and the impact of gross-to-net allowances[1].

Strategic Initiatives

Warranty Program

RedHill Biopharma has introduced a warranty program for Talicia, a first for a widespread community-treated condition. This program reimburses eligible patients' out-of-pocket costs if Talicia does not work, further supporting patient access and confidence in the treatment[1].

Commercial Focus

The company has streamlined its commercial operations, focusing on growing Talicia and Aemcolo sales. This includes efforts to improve gross-to-net yields through multiple mechanisms, reflecting a commitment to maximizing the value of its products[2].

Financial Restructuring and Cash Management

Recent Financial Restructuring

RedHill Biopharma has undertaken significant financial restructuring to strengthen its cash position. This includes a Global Termination Agreement that resulted in a $9.9 million cash influx, removal of the lien against Talicia, and restoration of control over cash collections. This restructuring aims to enhance cash management and focus on R&D and commercial activities for future growth[5].

Industry Recognition and Guidelines

ACG Guidelines

Talicia has been listed as a first-line choice for H. pylori treatment in the new American College of Gastroenterology (ACG) guidelines, further solidifying its position in the market[4].

Future Outlook

Market Potential

With an estimated U.S. market potential of up to $1.4 billion for H. pylori treatments, Talicia is well-positioned for continued growth. Its unique formulation and high efficacy rates make it a preferred choice among gastroenterologists, ensuring a strong market presence in the coming years[3].

Key Takeaways

• Market Leadership: Talicia is the most prescribed branded agent by U.S. gastroenterologists and is on track to become the most prescribed branded H. pylori therapy.
• Clinical Efficacy: It has demonstrated high eradication rates and minimal resistance to rifabutin, addressing a significant unmet medical need.
• Regulatory Exclusivity: Eligible for eight years of U.S. market exclusivity under the QIDP designation.
• Financial Performance: Strong prescription growth despite challenges from gross-to-net allowances.
• Strategic Initiatives: Introduction of a warranty program and focused efforts to improve gross-to-net yields.
• Financial Restructuring: Recent restructuring to strengthen cash position and enhance future growth.

FAQs

What is Talicia used for?

Talicia is used for the treatment of H. pylori infection in adults. It is a fixed-dose combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI)[4].

How effective is Talicia in treating H. pylori infections?

Talicia demonstrated an 84% eradication rate of H. pylori infection in the intent-to-treat group in its pivotal Phase 3 study, compared to 58% for the active comparator arm[4].

What regulatory exclusivity does Talicia have?

Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation[4].

How has Talicia's prescription growth been?

Talicia saw a 26% increase in prescriptions in Q4 2022 compared to Q4 2021 and a 57% year-over-year growth in prescriptions[1].

What is the warranty program for Talicia?

RedHill Biopharma has established a warranty program for Talicia, reimbursing eligible patients' out-of-pocket costs if the treatment does not work[1].

How has RedHill Biopharma's financial restructuring impacted Talicia?

The recent financial restructuring has resulted in a $9.9 million cash influx, removal of the lien against Talicia, and restoration of control over cash collections, enhancing the company's ability to focus on R&D and commercial activities for future growth[5].