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-two 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. Four 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:	52
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

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.

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			Y	Y
Novartis	LOCAMETZ	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	215841-001	Mar 23, 2022		RX	Yes	Yes
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
European Patent Office	3268337	PROCÉDÉS ET TROUSSES DE PRÉPARATION DE COMPLEXES DE RADIONUCLÉIDES (METHODS AND KITS FOR PREPARING RADIONUCLIDE COMPLEXES)
Japan	2024117783	ＰＳＭＡ結合性リガンド－リンカー結合体及び使用方法 (PSMA BINDING LIGAND-LINKER CONJUGATES AND METHODS FOR USING THE SAME)
Japan	7609824
New Zealand	583931	PSMA BINDING LIGAND-LINKER CONJUGATES AND METHODS FOR USING

Market Dynamics and Financial Trajectory for Locametz

Introduction to Locametz

Locametz, also known as gallium Ga 68 gozetotide (Ga68-PSMA-11), is a peptide-based, positron-emitting radiopharmaceutical developed by Advanced Accelerator Applications (AAA), now part of Novartis. It is designed to bind to prostate-specific membrane antigen (PSMA), a protein overexpressed in prostate cancer cells, aiding in the diagnosis and selection of patients eligible for PSMA-targeted therapies like Pluvicto[4].

Market Context: Oncology Drugs

The global oncology drugs market is experiencing rapid growth, driven by the increasing prevalence of cancer and the demand for innovative treatment options. By 2031, the market is projected to reach $532.91 billion, growing at a CAGR of 12.6% from 2024 to 2031. This growth is fueled by the adoption of targeted therapies and immunotherapies, which offer higher efficacy and reduced side effects compared to traditional chemotherapy regimens[3].

Role of Radiopharmaceuticals

Radiopharmaceuticals, such as Locametz and Pluvicto, are gaining significant attention due to their ability to selectively target tumors while sparing healthy cells. This targeted approach reduces side effects and improves patient outcomes. Novartis's acquisition of Advanced Accelerator Applications and Endocyte highlights the industry's interest in this sector, with investments totaling $2.1 billion and $3.9 billion, respectively[1].

Regulatory Approval and Clinical Evidence

Locametz received FDA approval in 2022 for use in diagnosing prostate cancer, particularly in identifying patients with metastatic castration-resistant prostate cancer (mCRPC) who are eligible for treatment with Pluvicto. The approval was based on substantial evidence from clinical trials, including the VISION trial, which demonstrated improved overall survival in patients undergoing PSMA-targeted therapy[4][5].

Financial Performance and Revenue Potential

The financial trajectory of Locametz is closely tied to the success of its companion therapy, Pluvicto. Pluvicto, which targets the same PSMA biomarker, has been priced at $42,500 per dose, with patients receiving a maximum of six doses. This pricing strategy, while high, is expected to be covered by most payers due to the drug's innovative potential and patient benefits[1].

The revenue generated from Pluvicto and other radiopharmaceuticals like Lutathera (approved for digestive tract cancers) indicates a strong market demand. Lutathera, for example, had sales of $115 million in the fourth quarter of 2021. Given the complementary role of Locametz in diagnosing and selecting patients for these therapies, its adoption is likely to contribute significantly to Novartis's revenue stream[1].

Competitive Landscape

The oncology drugs market is highly competitive, with key players including Novartis, Hoffmann-La Roche, Genentech, Gilead Sciences, AstraZeneca, and others. The development of radiopharmaceuticals like Locametz and Pluvicto positions Novartis favorably in this market, especially given the growing interest in targeted therapies. Other companies, such as Bayer, are also investing in similar technologies, indicating a robust competitive landscape[3].

Geographical Market

The oncology drugs market is dominated by North America due to the availability of advanced treatment options and infrastructure. However, the Asia Pacific region is expected to witness the highest growth through 2031, driven by developing healthcare infrastructure and a growing patient population in countries like China and India. This geographical expansion could further boost the demand for diagnostic tools like Locametz[3].

Side Effects and Safety Profile

While Locametz has shown a favorable safety profile, with no serious adverse reactions identified in clinical studies, the therapy it enables (Pluvicto) has side effects such as fatigue, dry mouth, nausea, and anemia. The safety and efficacy data from clinical trials support the benefit/risk profile of Locametz, making it a valuable diagnostic tool in the treatment of prostate cancer[5].

Financial Stewardship and Investment

Companies like Telix, which are also involved in the radiopharmaceutical sector, have demonstrated strong financial stewardship by controlling operational expenditure and improving working capital management. This approach allows for significant investments in product development programs, including late-stage assets and high-value therapeutic pipelines. Novartis, with its substantial resources and strategic acquisitions, is well-positioned to continue investing in the development and commercialization of radiopharmaceuticals like Locametz[2].

Key Takeaways

• Market Growth: The oncology drugs market, driven by targeted therapies, is expected to grow significantly, reaching $532.91 billion by 2031.
• Regulatory Approval: Locametz received FDA approval based on strong clinical evidence, particularly from the VISION trial.
• Financial Potential: The revenue from Pluvicto and other radiopharmaceuticals indicates a strong market demand for Locametz.
• Competitive Landscape: Novartis is well-positioned in the competitive oncology market with its radiopharmaceutical portfolio.
• Geographical Expansion: Growing demand in the Asia Pacific region could further boost the adoption of Locametz.
• Safety Profile: Locametz has a favorable safety profile, supporting its use in diagnosing prostate cancer.

FAQs

Q: What is Locametz used for? Locametz is a radiopharmaceutical used for diagnosing prostate cancer, specifically to identify patients with metastatic castration-resistant prostate cancer (mCRPC) who are eligible for treatment with Pluvicto.

Q: How does Locametz work? Locametz binds to prostate-specific membrane antigen (PSMA), a protein overexpressed in prostate cancer cells, allowing for targeted diagnosis and patient selection for PSMA-targeted therapies.

Q: What is the regulatory status of Locametz? Locametz received FDA approval in 2022 for its intended use in diagnosing prostate cancer.

Q: What are the common side effects associated with the therapy enabled by Locametz? The therapy enabled by Locametz, Pluvicto, has side effects such as fatigue, dry mouth, nausea, and anemia, although Locametz itself has a favorable safety profile.

Q: How does the financial performance of Novartis relate to Locametz? The financial performance of Novartis, particularly from sales of radiopharmaceuticals like Pluvicto and Lutathera, indicates a strong revenue potential for Locametz as a diagnostic tool in the same therapeutic pathway.

Cited Sources

1. Novartis wins FDA OK for radiopharmaceutical drug, cashing in on ... - Biopharma Dive
2. TLX Q4-2022 Earnings Call - Alpha Spread
3. Oncology Drugs Market to Reach USD 532.91 Billion by 2031 - Coherent Market Insights
4. NDA 215841, Locametz/gallium Ga 68 gozetotide - FDA
5. Regulatory Decision Summary for Locametz - Health Products and Food Branch Inspectorate