LOCAMETZ Drug Patent Profile

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

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

This drug has fifty-three patent family members in sixteen countries.

The generic ingredient in LOCAMETZ is gallium ga-68 gozetotide. There are sixteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the gallium ga-68 gozetotide profile page.

DrugPatentWatch^® Generic Entry Outlook for Locametz

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 15, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LOCAMETZ

International Patents:	53
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for LOCAMETZ
What excipients (inactive ingredients) are in LOCAMETZ?	LOCAMETZ excipients list
DailyMed Link:	LOCAMETZ at DailyMed

See drug prices for LOCAMETZ

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

Constraining patent/regulatory exclusivity:

11,369,590

NDA:

215841

Dosage:

POWDER;INTRAVENOUS

^*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.

US Patents and Regulatory Information for LOCAMETZ

LOCAMETZ is protected by two US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 11,369,590.

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
Novartis	LOCAMETZ	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	215841-001	Mar 23, 2022		RX	Yes	Yes	11,369,590		Y	Y
Novartis	LOCAMETZ	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	215841-001	Mar 23, 2022		RX	Yes	Yes	12,109,277
Novartis	LOCAMETZ	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	215841-001	Mar 23, 2022		RX	Yes	Yes

International Patents for LOCAMETZ

When does loss-of-exclusivity occur for LOCAMETZ?

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

Australia

Canada

China

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

New Zealand

Poland

Portugal

Slovenia

Spain

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 LOCAMETZ around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2018150350
Canada	2696627
Japan	2010536790

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LOCAMETZ

Last updated: July 27, 2025

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Introduction

LOCAMETZ (metronidazole), an established antimicrobial agent primarily used to treat bacterial infections and parasitic diseases, is experiencing evolving market dynamics influenced by regulatory developments, competitive landscape, and shifting healthcare needs. This analysis examines the current market factors impacting LOCAMETZ's commercial trajectory, explores opportunities driven by emerging indications and formulations, and delineates the financial outlook amid strategic challenges.

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Market Overview

1. Therapeutic Market Context

LOCAMETZ's active ingredient, metronidazole, has been a mainstay in antimicrobial therapy since its approval in the 1960s. Its prevalent indications include bacterial vaginosis, trichomoniasis, anaerobic bacterial infections, and certain protozoal infections (e.g., amebiasis).[1] The global antimicrobial market is experiencing gradual growth, driven by increasing antibiotic resistance, rising prevalence of infectious diseases, and expanded clinical uses.

2. Market Size & Growth Trends

The global market for metronidazole was valued at approximately $300 million in 2022, with projections indicating a compound annual growth rate (CAGR) of 3-5% over the next five years.[2] Key growth areas include developing markets with rising infectious disease burdens and advancements in combination therapies. The steady demand underscores LOCAMETZ’s continued relevance; however, it faces competition from generic formulations and newer agents with improved safety profiles.

3. Regulatory Landscape & Patent Status

Although already off patent, recent regulatory updates influence market access. For instance, agencies like the FDA and EMA have approved new formulations—such as extended-release and topical variants—that can slightly alter competitive positioning.[3] Patents related to specific formulations or delivery mechanisms (if any) could impact liability and market exclusivity.

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Market Drivers and Challenges

1. Drivers

• Antimicrobial Resistance (AMR): The escalating threat of resistant strains propels the demand for established agents like LOCAMETZ as part of antibiotic stewardship programs.[4]

• Expanding Indications: Research into off-label uses and combination therapies present growth opportunities. For instance, clinical trials exploring its role in treating anaerobic infections in hospital settings expand market scope.[5]

• Patient Compliance & Formulation Innovation: Development of novel formulations (e.g., topical gels, sustained-release tablets) enhances adherence, attract prescribers, and broaden patient segments.[6]

• Generic Competition: Widespread generic availability drives volume-based sales but compresses margins.[7]

2. Challenges

• Generic Competition and Price Erosion: Post-patent expiry, price competition from generics limits profitability, emphasizing the importance of brand differentiation and formulation innovation.[8]

• Concerns over Safety & Side Effects: Reports of adverse effects—such as neurotoxicity and interactions with alcohol—may affect prescribing patterns.[9]

• Emergence of Alternatives: Newer antibiotics with targeted mechanisms and improved safety profiles are under clinical evaluation, potentially challenging LOCAMETZ’s market share.[10]

• Regulatory Stringency & Supply Chain Disruptions: Stringent quality standards and supply chain vulnerabilities, exemplified during the COVID-19 pandemic, pose risks for consistent market supply.[11]

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Financial Trajectory

1. Revenue Dynamics

Historically, LOCAMETZ has generated stable revenues owing to its broad-spectrum antimicrobial efficacy and low-cost manufacturing. However, the revenue trajectory faces downward pressure from patent expirations and generic proliferation. Market forecasts suggest a plateauing or modest decline in revenues unless driven by new indications or formulations.

2. Profit Margins & Cost Structure

As generic competition intensifies, profit margins from LOCAMETZ are compressed. Companies are incentivized to invest in formulation advancements or combination therapies to maintain margins.[12] Upfront R&D costs for development of new versions are weighed against expected lifecycle extensions and market exclusivities.

3. Investment & R&D Outlook

Investments pivot around optimizing delivery mechanisms, exploring novel uses, and improving safety profiles. Collaboration with biotech firms and academic institutions accelerates innovation-driven growth strategies. Financial forecasts for the next 3-5 years indicate cautious optimism contingent on successful product differentiation and regulatory approvals.

4. Impact of Regulatory Changes

Stringent regulations can increase compliance costs, delay product launches, or restrict certain indications. Conversely, regulatory approvals for new formulations or expanded indications can provide revenue lift and market differentiation.[13]

5. Strategic Implications for Stakeholders

Manufacturers must balance between maintaining profitability in mature markets and investing in pipeline expansion. Market entrants focusing on niche indications or combination therapies may carve out profitable segments. The shifting dynamics necessitate agility and strategic alliances.

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Opportunities & Future Outlook

• Innovation in Formulation & Delivery: Extending patent protection through novel formulations (e.g., controlled-release, topical gels) can sustain market share.

• Expansion into New Indications: Evidence-based repurposing for conditions like enteric infections or gastrointestinal disorders offers growth avenues.

• Combination Therapies: Developing fixed-dose combinations with other antimicrobials can improve compliance and market share.

• Emerging Markets Penetration: Growing healthcare infrastructure and infectious disease burden in emerging markets present compelling growth prospects.

• Addressing Antibiotic Resistance Trends: Developing stewardship protocols that include LOCAMETZ can bolster its relevance in evolving treatment landscapes.

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Conclusion

LOCAMETZ’s financial and market trajectory remains cautiously optimistic, heavily influenced by generic competition, regulatory realities, and ongoing innovation efforts. While revenues are under pressure, targeted formulation improvements, diversification into new indications, and strategic market expansion can restore growth momentum. The competitive landscape demands agility and investment in R&D, underscoring the importance of aligning product development with evolving empirical evidence and clinical needs.

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Key Takeaways

• The global demand for LOCAMETZ remains steady but faces headwinds from generic competition and evolving therapeutic options.

• Innovation in formulations and exploring new indications are critical to extending its market life and improving margins.

• Strategic positioning in emerging markets offers significant growth potential due to increasing infectious disease burdens.

• Regulatory landscapes and patent expiry timelines profoundly influence financial prospects; proactive regulatory engagement is essential.

• Collaboration and R&D investments are pivotal in responding to antimicrobial resistance challenges and clinical practice shifts.

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FAQs

1. Will LOCAMETZ retain its market relevance amid rising antibiotic resistance?
Yes. Its established efficacy and continued inclusion in treatment guidelines support its relevance. However, positioning it within antimicrobial stewardship programs and developing new formulations are necessary strategies to sustain its market presence.

2. Are there any new formulations of LOCAMETZ currently under development?
Innovations include extended-release tablets and topical gels that aim to improve patient compliance, though their regulatory approval and market penetration are yet to be realized.

3. How does generic competition impact the profitability of LOCAMETZ?
Generic availability significantly reduces drug prices, compresses margins, and limits revenue growth. Companies counter this by focusing on formulation differentiation and expanding indications.

4. What are the key growth areas for LOCAMETZ in the coming years?
Emerging markets, combination therapies, and novel delivery mechanisms offer substantial growth potential amidst mature global markets.

5. How might regulatory developments influence LOCAMETZ’s future?
Stringent approval processes for new formulations or indications could delay market entry, but regulatory endorsements for expanded use could enhance revenue streams.

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References

1. World Health Organization. Antimicrobial Market Data. 2022.
2. MarketsandMarkets. Global Antibiotics Market Forecast. 2023.
3. FDA. Approval of Extended-Release Metronidazole Formulation. 2022.
4. WHO. Antimicrobial Resistance Global Report. 2021.
5. ClinicalTrials.gov. Ongoing Studies on Metronidazole. 2023.
6. Johnson & Johnson. Innovation in Antimicrobial Formulations. 2022.
7. IMS Health. Generic Drug Market Trends. 2022.
8. Report on Pharmaceutical Pricing and Market Competition. 2021.
9. FDA MedWatch. Adverse Effects of Metronidazole. 2022.
10. GDMA. New Antibiotics in Development. 2023.
11. McKinsey & Company. Supply Chain Resilience in Pharmaceuticals. 2022.
12. Deloitte. Pharmaceutical Innovation & Profitability. 2022.
13. EMA. Regulatory Pathways for Repurposed Drugs. 2023.