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PYLARIFY Drug Patent Profile

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

Pylarify is a drug marketed by Progenics Pharms Inc and is included in one NDA. There are five patents protecting this drug.

This drug has ninety-six patent family members in twenty-four countries.

The generic ingredient in PYLARIFY is piflufolastat f-18. One supplier is listed for this compound. Additional details are available on the piflufolastat f-18 profile page.

DrugPatentWatch^® Generic Entry Outlook for Pylarify

Pylarify will be eligible for patent challenges on May 26, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 21, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for PYLARIFY

International Patents:	96
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	5
Patent Applications:	22
Drug Prices:	Drug price information for PYLARIFY
What excipients (inactive ingredients) are in PYLARIFY?	PYLARIFY excipients list
DailyMed Link:	PYLARIFY at DailyMed

See drug prices for PYLARIFY

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

Constraining patent/regulatory exclusivity:

8,778,305

NDA:

214793

Dosage:

SOLUTION;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.

Recent Clinical Trials for PYLARIFY

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

Sponsor	Phase
Oregon Health and Science University	Phase 4
OHSU Knight Cancer Institute	Phase 4
Progenics Pharmaceuticals, Inc.	Phase 4

See all PYLARIFY clinical trials

Pharmacology for PYLARIFY

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for PYLARIFY

PYLARIFY is protected by five US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 8,778,305.

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
Progenics Pharms Inc	PYLARIFY	piflufolastat f-18	SOLUTION;INTRAVENOUS	214793-001	May 26, 2021		RX	Yes	Yes	8,778,305		Y	Y
Progenics Pharms Inc	PYLARIFY	piflufolastat f-18	SOLUTION;INTRAVENOUS	214793-001	May 26, 2021		RX	Yes	Yes	11,851,407		Y	Y
Progenics Pharms Inc	PYLARIFY	piflufolastat f-18	SOLUTION;INTRAVENOUS	214793-001	May 26, 2021		RX	Yes	Yes	9,861,713		Y	Y
Progenics Pharms Inc	PYLARIFY	piflufolastat f-18	SOLUTION;INTRAVENOUS	214793-001	May 26, 2021		RX	Yes	Yes	10,947,197		Y	Y
Progenics Pharms Inc	PYLARIFY	piflufolastat f-18	SOLUTION;INTRAVENOUS	214793-001	May 26, 2021		RX	Yes	Yes
Progenics Pharms Inc	PYLARIFY	piflufolastat f-18	SOLUTION;INTRAVENOUS	214793-001	May 26, 2021		RX	Yes	Yes	8,487,129		Y	Y

International Patents for PYLARIFY

When does loss-of-exclusivity occur for PYLARIFY?

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

Australia

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hong Kong

Hungary

Japan

Lithuania

Netherlands

Norway

Poland

Portugal

Russian Federation

Slovenia

South Korea

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 PYLARIFY around the world.

Country	Patent Number	Title	Estimated Expiration
Lithuania	3222615
Japan	7427703
European Patent Office	4023624	HÉTÉRODIMÈRES D'ACIDE GLUTAMIQUE (HETERODIMERS OF GLUTAMIC ACID)
Canada	2987744	AGENTS DE LIAISON AU PSMA ET SES UTILISATIONS (PSMA-BINDING AGENTS AND USES THEREOF)
Japan	2017048204	ＰＳＭＡ結合剤及びその使用 (PSMA-BINDING AGENTS AND USES THEREOF)
Japan	6524046
Portugal	2097111

Supplementary Protection Certificates for PYLARIFY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2318366	2023C/540	Belgium		PRODUCT NAME: PIFLUFOLASTAT (18F) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1746 20230725
2318366	122023000060	Germany		PRODUCT NAME: PIFLUFOLASTAT (18F) ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1746 20230724
2318366	301250	Netherlands		PRODUCT NAME: PIFLUFOLASTAT (18F) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1746 20230725
2318366	LUC00323	Luxembourg		PRODUCT NAME: PIFLUFOLASTAT (18F) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/23/1746 20230725
2318366	C20230027 00410	Estonia		PRODUCT NAME: PIFLUFOLASTAAT (18F);REG NO/DATE: EU/1/23/1746 25.07.2023
2318366	PA2023534	Lithuania		PRODUCT NAME: PIFLUFOLASTATAS (18F) ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/23/1746 20230724
2318366	37/2023	Austria		PRODUCT NAME: PIFLUFOLASTAT (18F) ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1746 (MITTEILUNG) 20230725

PYLARIFY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PYLARIFY

Introduction

PYLARIFY, a Prostate-Specific Membrane Antigen (PSMA) targeted PET imaging agent, has been a cornerstone in the diagnostic radiopharmaceutical market, particularly for prostate cancer. Developed by Lantheus Holdings, Inc., PYLARIFY has shown remarkable growth and is poised to continue its dominance in the market.

Market Position and Growth

Current Market Performance

PYLARIFY has demonstrated impressive sales growth, with a 61.4% increase in full-year sales in 2023, reaching $851.3 million. This growth is attributed to the increasing utilization of PSMA PET imaging at existing customer sites and the expansion of access through a diverse F-18 distributor network[2][4][5].

Projected Sales

For 2024, Lantheus is optimistic about surpassing $1 billion in net sales for PYLARIFY, a milestone that would make it the first PET imaging agent to achieve blockbuster status. This projection is supported by a mid-teen net revenue growth forecast, driven by volume and a slight price advantage[2][4][5].

Clinical and Commercial Differentiation

Clinical Excellence

PYLARIFY's success is rooted in its clinical differentiation. The product offers a proprietary PSMA-targeted ligand combined with the F-18 isotope, which has demonstrated a high positive predictive value and high reader agreement in registrational trials. This provides clinicians with confidence in the accuracy and consistency of image interpretation, ultimately influencing patient management decisions[2].

Commercial Strength

Commercially, PYLARIFY stands out as the only PSMA imaging agent widely available through a diverse F-18 distributor supply network, ensuring convenient and reliable supply. This extensive distribution network covers all 48 contiguous states, Washington D.C., Puerto Rico, and Europe through strategic partnerships[2][4].

Financial Performance

Revenue Growth

Lantheus reported a 39% year-over-year revenue increase to $1.3 billion in 2023, with PYLARIFY being a significant contributor. For the third quarter of 2024, worldwide revenue increased by 18.4% to $378.7 million, with PYLARIFY sales reaching $259.8 million, a 20.6% increase from the prior year[2][3][5].

Profitability

The company has shown marked improvement in financial metrics, including a 251 basis point rise in gross profit margin during the fourth quarter of 2023 and a 38.4% increase in operating profit. The GAAP fully diluted earnings per share saw a 47.7% increase year-over-year, indicating strong profitability[2].

Adjusted Financial Metrics

For the third quarter of 2024, adjusted net income (non-GAAP) increased by 20.4% to $124.1 million, and adjusted fully diluted earnings per share (non-GAAP) rose by 15.6% to $1.70. These metrics reflect the company's financial discipline and operational excellence[5].

Strategic Investments and Expansion

Operational Excellence

Lantheus's focus on operational excellence, including reliability, scale, and flexibility in delivery times, has been crucial in supporting the growing demand for PYLARIFY. The company continues to expand its Pharmacy Manufacturing Facility network to meet this demand[4].

Market Expansion and Education

Lantheus has launched marketing campaigns, such as "Let's Be Clear," to educate the prostate cancer community about the benefits of PSMA PET with PYLARIFY. This, combined with the expansion of the sales force, has helped drive growth and maintain market leadership[4].

Strategic Partnerships and Pipeline Development

The company is investing in its pipeline, including oncology radiotherapeutics and Alzheimer's disease radiodiagnostics. Strategic partnerships and co-development plans, such as those with Perspective Therapeutics, are also part of Lantheus's growth strategy[5].

Challenges and Mitigation Strategies

Transitional Pass-Through Payment (TPT) Expiry

Lantheus is preparing for the potential impact of the expiration of the transitional pass-through payment (TPT) at the end of 2024. The company is actively implementing a multi-faceted strategy to mitigate this impact and ensure continued market leadership[4].

Industry Context and Market Projections

Targeted Radiopharmaceuticals Market

The targeted radiopharmaceuticals (TRP) market, which includes both therapeutics and diagnostics, is projected to grow significantly. The market is expected to reach approximately $6 to $9 billion by 2028, with PYLARIFY and other products like Pluvicto from Novartis playing key roles in this growth[1].

Deal-Making and Partnerships

The TRP landscape is also shaped by significant deal-making activity. Over the last seven years, nearly 200 deals have been made, with about two-thirds involving TRP therapeutics and one-third involving TRP diagnostics. Recent deals, such as those between Lilly and POINT Biopharma, BMS and RayzeBio, and Novartis and Mariana Oncology, highlight the industry's investment in this sector[1].

Key Takeaways

• Sales Growth: PYLARIFY is on track to exceed $1 billion in sales in 2024, driven by increasing volumes and a strong distribution network.
• Clinical and Commercial Differentiation: PYLARIFY's proprietary PSMA-targeted ligand and widespread availability through a diverse F-18 distributor network are key factors in its success.
• Financial Performance: Lantheus has reported significant revenue and profitability growth, with adjusted financial metrics indicating strong operational excellence.
• Strategic Investments: The company is investing in its pipeline and expanding its market presence through strategic partnerships and marketing campaigns.
• Challenges: Lantheus is preparing to mitigate the impact of the TPT expiry at the end of 2024.

FAQs

What is PYLARIFY used for?

PYLARIFY is a Prostate-Specific Membrane Antigen (PSMA) targeted PET imaging agent used primarily for diagnosing prostate cancer.

How has PYLARIFY performed in terms of sales?

PYLARIFY saw a 61.4% increase in full-year sales in 2023, reaching $851.3 million, and is projected to exceed $1 billion in sales in 2024.

What are the key factors driving PYLARIFY's success?

The key factors include its clinical differentiation with a proprietary PSMA-targeted ligand, commercial differentiation with widespread availability, and operational excellence in supply and distribution.

How is Lantheus preparing for the TPT expiry?

Lantheus is actively implementing a multi-faceted strategy to mitigate the impact of the TPT expiry, ensuring continued market leadership and financial stability.

What are Lantheus's future growth strategies?

Lantheus plans to leverage its balance sheet for strategic business development, expand its pipeline through investments in oncology radiotherapeutics and Alzheimer's disease radiodiagnostics, and maintain its market leadership through operational excellence and strategic partnerships.

Sources

1. Innovations and trends in targeted radiopharmaceuticals - ZS
2. LNTH Q4-2023 Earnings Call - Alpha Spread
3. Lantheus Reports Third Quarter 2024 Financial Results - Stock Titan
4. Lantheus reports robust growth, eyes $1B in PYLARIFY sales - Investing.com
5. Lantheus Reports Third Quarter 2024 Financial Results - GlobeNewswire