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POSLUMA Drug Patent Profile

When do Posluma patents expire, and when can generic versions of Posluma launch?

Posluma is a drug marketed by Blue Earth and is included in one NDA. There are two patents protecting this drug.

This drug has thirty patent family members in fourteen countries.

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

DrugPatentWatch^® Generic Entry Outlook for Posluma

Posluma will be eligible for patent challenges on May 25, 2027. 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 May 25, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for POSLUMA

International Patents:	30
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for POSLUMA
What excipients (inactive ingredients) are in POSLUMA?	POSLUMA excipients list
DailyMed Link:	POSLUMA at DailyMed

See drug prices for POSLUMA

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216023

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.

Pharmacology for POSLUMA

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for POSLUMA

POSLUMA is protected by four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes			Y
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes				Y
Blue Earth	POSLUMA	flotufolastat f-18 gallium	SOLUTION;INTRAVENOUS	216023-001	May 25, 2023		RX	Yes	Yes

International Patents for POSLUMA

See the table below for patents covering POSLUMA around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20200064057	이중 모드 방사성 트레이서 및 치료법
Japan	7059372
Brazil	112020001785	radiotraçador e compostos radioterapêuticos bimodais
South Africa	202000467	DUAL MODE RADIOTRACER AND -THERAPEUTICS
Japan	2022101601	デュアルモードの放射性トレーサーおよび療法剤
China	115484992	药物制剂 (Pharmaceutical formulation)
Mexico	2023007914	MARCADOR RADIOACTIVO DE MODO DUAL Y TERAPEUTICOS. (DUAL MODE RADIOTRACER AND -THERAPEUTICS.)

POSLUMA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for POSLUMA

Introduction to POSLUMA

POSLUMA (flotufolastat F 18) is a groundbreaking PET radiopharmaceutical developed by Blue Earth Diagnostics, a Bracco company, and distributed by PETNET Solutions Inc, a Siemens Healthineers company. It is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer, particularly those with suspected metastasis or recurrence based on elevated serum PSA levels[1].

Regulatory Approval and Commercial Availability

POSLUMA received FDA approval on May 25, 2023, and is now commercially available in the United States through multiple radiopharmacies of PETNET Solutions. This widespread availability is facilitated by the large national network of cyclotron-equipped radiopharmacies, marking a significant milestone in the number of sites authorized for the manufacturing of a radiopharmaceutical upon its initial FDA approval[1].

Clinical Utility and Impact

The clinical utility of POSLUMA has been highlighted in various studies, including the Phase 3 SPOTLIGHT trial. This trial demonstrated that actionable information from POSLUMA imaging resulted in changes in management for 89% of patients with recurrent prostate cancer. This data underscores the significant impact of POSLUMA on treatment plans and patient care[4].

Market Access and Reimbursement

To enhance patient access, the Centers for Medicare & Medicaid Services (CMS) has granted transitional pass-through payment status for POSLUMA. This designation allows for separate payment for the diagnostic radiopharmaceutical, in addition to reimbursement for the PET/CT scan itself, in hospital outpatient settings. This move is expected to increase patient access to this innovative product[5].

Financial Implications

The commercial availability and regulatory approvals of POSLUMA are likely to have a positive financial impact on Blue Earth Diagnostics and its partners. Here are some key financial aspects:

Revenue Generation

The widespread distribution and CMS reimbursement for POSLUMA are expected to generate significant revenue. The product's inclusion in nationally recognized clinical oncology guidelines further solidifies its market position and potential for revenue growth[4].

Partnerships and Collaborations

Blue Earth Diagnostics' partnership with PETNET Solutions Inc. is crucial for the broad distribution of POSLUMA. This partnership, which began in 2015, has been instrumental in making other innovative PET biomarkers available, and it is expected to continue driving revenue through the commercialization of POSLUMA[1].

Educational and Training Programs

The company's investment in practical education programs for physicians and staff at imaging centers is another financial commitment. These programs aim to ensure the appropriate use of POSLUMA, including image acquisition and reader training, which can also influence the financial trajectory by ensuring optimal product utilization[1].

Competitive Landscape

POSLUMA enters a market with existing PSMA-targeted PET radiopharmaceuticals but distinguishes itself through its novel radiohybrid technology and high-affinity binding. This differentiation, combined with its inclusion in clinical guidelines, positions POSLUMA competitively in the market for prostate cancer diagnostics[1][4].

Future Outlook

Given the strong clinical data and regulatory support, the future outlook for POSLUMA appears promising. The product's ability to provide clinically useful information, especially at low PSA levels, and its low urinary bladder activity, are key factors that will continue to drive its adoption and revenue growth.

Expanding Distribution

Additional PETNET sites are expected to manufacture POSLUMA before the end of the summer, further expanding its availability and reach. This expansion is likely to increase market penetration and revenue[1].

Continued Regulatory Support

The CMS's transitional pass-through payment status and the ongoing communication with Medicare carriers, Medicare Advantage Plans, private insurers, and radiology benefit managers are expected to continue supporting the financial trajectory of POSLUMA by ensuring broad access and reimbursement[1][5].

Key Takeaways

• Regulatory Approval: POSLUMA received FDA approval in May 2023 and is commercially available in the U.S.
• Clinical Utility: POSLUMA has shown significant impact on treatment plans for patients with recurrent prostate cancer.
• Market Access: CMS has granted transitional pass-through payment status to enhance patient access.
• Financial Implications: Expected to generate significant revenue through widespread distribution and reimbursement.
• Competitive Landscape: Distinguishes itself through novel radiohybrid technology and high-affinity binding.
• Future Outlook: Promising due to strong clinical data, regulatory support, and expanding distribution.

FAQs

Q: What is POSLUMA used for?

A: POSLUMA is used for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer, particularly those with suspected metastasis or recurrence based on elevated serum PSA levels.

Q: When was POSLUMA approved by the FDA?

A: POSLUMA was approved by the FDA on May 25, 2023.

Q: How is POSLUMA distributed in the U.S.?

A: POSLUMA is distributed through multiple radiopharmacies of PETNET Solutions Inc, a Siemens Healthineers company.

Q: What is the impact of CMS's transitional pass-through payment status on POSLUMA?

A: The CMS's transitional pass-through payment status allows for separate payment for POSLUMA and the PET/CT scan itself in hospital outpatient settings, increasing patient access.

Q: How does POSLUMA differentiate itself in the market?

A: POSLUMA differentiates itself through its novel radiohybrid technology and high-affinity binding, providing clinically useful information especially at low PSA levels.

Cited Sources

1. Siemens Healthineers: "Blue Earth Diagnostics and PETNET Solutions Inc. Announce U.S. Commercial Availability of POSLUMA Injection"
2. PR Newswire: "Poseida Therapeutics Provides Updates and Financial Results for the Second Quarter of 2024"
3. FDA: "Prescription Drug User Fee Act - FDA"
4. BioSpace: "Blue Earth Diagnostics Highlights Clinical Utility of POSLUMA (Flotufolastat F 18) PET and Post-scan Changes in Management in Patients with Suspected Recurrence of Prostate Cancer at ASCO GU"
5. Radiology Business: "CMS grants transitional pass-through payment status for prostate cancer PET imaging agent"