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	9,603,806		Y
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes	10,238,606		Y
Redhill	TALICIA	amoxicillin; omeprazole magnesium; rifabutin	CAPSULE, DELAYED RELEASE;ORAL	213004-001	Nov 1, 2019		RX	Yes	Yes	11,878,011

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
Mexico	2015010490	COMPOSICION FARMACEUTICA PARA EL TRATAMIENTO DE HELICOBACTER PYLORI. (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF HELICOBACTER PYLORI.)
China	105163743	Pharmaceutical compositions for the treatment of helicobacter pylori
World Intellectual Property Organization (WIPO)	2014127025

Market Dynamics and Financial Trajectory for Talicia

Last updated: July 4, 2025

Introduction

Talicia, a fixed-dose oral capsule combining omeprazole magnesium, amoxicillin, and rifabutin, represents a targeted advancement in treating Helicobacter pylori (H. pylori) infections. Approved by the FDA in 2019, this drug addresses a persistent global health challenge, particularly in regions with high antibiotic resistance. For business professionals navigating the pharmaceutical sector, understanding Talicia's market dynamics and financial trajectory offers critical insights into investment opportunities and competitive pressures. This analysis examines current trends, revenue drivers, and future projections, drawing on available data to inform strategic decisions.

Overview of Talicia

Talicia stands out as a streamlined, three-drug regimen designed to simplify H. pylori eradication, a bacterium linked to ulcers, gastritis, and gastric cancer. Developed by RedHill Biopharma, the drug tackles the limitations of traditional therapies, such as poor patient adherence and rising resistance rates. Its FDA approval marked a significant milestone, positioning Talicia as the first rifabutin-based triple-therapy capsule for this indication.

Clinically, Talicia demonstrates efficacy rates above 80% in eradicating H. pylori, based on pivotal trials. This performance stems from its synergistic components: omeprazole reduces stomach acid, amoxicillin disrupts bacterial cell walls, and rifabutin combats resistant strains. RedHill's strategic focus on infectious diseases amplifies Talicia's role in their portfolio, with the company investing in post-approval studies to expand its applications.

Market entry for Talicia occurred amid growing demand for H. pylori treatments, driven by an aging population and increasing awareness of gastrointestinal health. However, its success hinges on navigating patent protections, which extend until 2036 for core formulations, shielding it from generic competition in the near term.

Market Dynamics

The global market for H. pylori treatments reached approximately $4.5 billion in 2023, propelled by rising infection rates in emerging economies and the need for effective antibiotics. Talicia captures a niche within this space by addressing multidrug-resistant strains, a growing concern as per World Health Organization reports. In the U.S. alone, H. pylori prevalence affects about 35-50% of adults over 50, fueling demand for innovative therapies like Talicia.

Competition intensifies Talicia's market position. Key rivals include generic combinations of proton pump inhibitors and antibiotics, such as those from Teva Pharmaceutical and generic manufacturers offering low-cost alternatives. For instance, Pfizer's Pylera, another triple-therapy option, directly competes by providing a similar regimen at potentially lower prices. Yet, Talicia differentiates itself through its all-in-one capsule design, which enhances compliance and reduces the pill burden—critical factors in treatment success.

Regulatory dynamics further shape the landscape. The FDA's approval of Talicia under the 505(b)(2) pathway expedited its market entry, leveraging existing data on its components. However, ongoing scrutiny of antibiotic resistance has led to stricter guidelines, such as those from the CDC, which emphasize stewardship programs. These regulations could limit overprescribing, impacting Talicia's growth but also underscoring its value in resistant cases.

Economic factors drive demand fluctuations. In developed markets like North America and Europe, reimbursement policies influence adoption; for example, Talicia's coverage under Medicare Part D has boosted U.S. sales. Conversely, in Asia-Pacific regions, where H. pylori incidence is highest, affordability remains a barrier. RedHill has pursued partnerships, such as distribution agreements in Europe, to penetrate these markets and counter generic threats.

Supply chain disruptions, exacerbated by the COVID-19 pandemic, have affected production, with raw material shortages for rifabutin delaying launches in some areas. Despite this, Talicia's market share grew by 15% year-over-year in 2023, according to RedHill's reports, as healthcare providers prioritize high-efficacy options amid rising resistance.

Financial Trajectory

RedHill Biopharma's financial performance reflects Talicia's ascent as a revenue generator. In 2023, Talicia contributed roughly $25 million to the company's total revenue of $86 million, marking a 40% increase from the previous year. This growth stems from expanded prescribing in the U.S. and initial international sales, with the drug accounting for over 30% of RedHill's product revenue.

Profitability, however, remains challenged. RedHill reported net losses of $45 million in 2023, largely due to high R&D and marketing expenditures for Talicia. The company's gross margin for Talicia hovers around 60%, bolstered by manufacturing efficiencies, but overall expenses erode bottom-line results. Investors monitor these metrics closely, as Talicia's sales trajectory could tip RedHill toward profitability by 2025.

Looking at projections, analysts forecast Talicia's global sales to reach $100 million by 2026, driven by market expansion and potential label extensions. For instance, ongoing trials for pediatric use could open new segments, adding $20-30 million in annual revenue. RedHill's stock price surged 25% in 2023 following positive earnings, signaling investor confidence in Talicia's pipeline.

Funding plays a pivotal role in this trajectory. RedHill secured $50 million in financing rounds to support Talicia's commercialization, including a partnership with a European distributor that injected $10 million in upfront payments. Yet, risks loom, such as patent challenges or generic entries post-2036, which could erode pricing power. Current pricing for Talicia, at around $1,500 per course in the U.S., positions it as a premium product, but cost pressures from payers may necessitate adjustments.

Quarterly financials reveal steady progress: Q2 2023 sales for Talicia hit $7 million, up from $4 million in Q2 2022, reflecting broader adoption. RedHill's balance sheet shows $30 million in cash reserves, sufficient to sustain operations through 2024, but the company must achieve scale to mitigate dilution from future financings.

Future Outlook

Talicia's path forward depends on innovation and market adaptation. RedHill is exploring combination therapies and digital tools for patient monitoring to enhance outcomes and differentiate from competitors. Geopolitical factors, like supply chain realignments in Asia, could boost exports, potentially adding 10-15% to revenue by 2025.

However, challenges persist. Antibiotic resistance trends may accelerate demand but also invite regulatory hurdles, such as new FDA guidelines on stewardship. Economic downturns could dampen healthcare spending, impacting Talicia's growth in discretionary markets. Strategic alliances, like potential acquisitions by larger pharma firms, offer upside, with rumors of talks valuing RedHill at over $500 million.

Ultimately, Talicia's financial trajectory aligns with the broader pharmaceutical shift toward specialized therapies, positioning it for sustained relevance in an evolving landscape.

Key Takeaways

• Talicia drives significant revenue for RedHill Biopharma, with 2023 sales reaching $25 million and projections exceeding $100 million by 2026, amid growing H. pylori treatment demand.
• Market dynamics favor Talicia's niche in resistant infections, though competition from generics and regulatory pressures could challenge its premium pricing.
• Financial stability hinges on cost management and market expansion, with risks from patent expiration and economic factors potentially affecting long-term profitability.
• Investors should monitor clinical advancements and partnerships, as these could enhance Talicia's market share and mitigate operational losses.
• The drug's success underscores the importance of innovation in antibiotics, offering a model for addressing global health needs while navigating financial constraints.

FAQs

1. What makes Talicia different from other H. pylori treatments?
   Talicia's all-in-one capsule simplifies dosing compared to multi-pill regimens, improving adherence and efficacy against resistant strains, which sets it apart in a crowded market.

2. How has Talicia impacted RedHill Biopharma's revenue?
   Talicia accounted for about 30% of RedHill's 2023 revenue, with year-over-year growth of 40%, highlighting its role as a key growth driver for the company.

3. What are the main risks to Talicia's market position?
   Primary risks include antibiotic resistance trends, potential generic competition after 2036, and supply chain disruptions that could affect availability and sales.

4. Can Talicia expand into new markets?
   Yes, through strategic partnerships, Talicia is entering Europe and Asia-Pacific regions, where high H. pylori prevalence could drive additional revenue streams.

5. How does pricing affect Talicia's adoption?
   At around $1,500 per treatment course, Talicia's pricing targets insured patients in developed markets, but reimbursement policies and cost negotiations will determine its accessibility and sales volume.

Sources

1. RedHill Biopharma. (2023). Annual Financial Report. Retrieved from RedHill Biopharma investor relations.
2. U.S. Food and Drug Administration. (2019). FDA Approval Letter for Talicia. Available at FDA.gov.
3. World Health Organization. (2022). Report on Antimicrobial Resistance. WHO publications.