PASIREOTIDE PAMOATE - Generic Drug Details

What are the generic drug sources for pasireotide pamoate and what is the scope of patent protection?

Pasireotide pamoate is the generic ingredient in one branded drug marketed by Recordati Rare and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pasireotide pamoate has one hundred and thirty-five patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for PASIREOTIDE PAMOATE

International Patents:	135
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Patent Applications:	15
DailyMed Link:	PASIREOTIDE PAMOATE at DailyMed

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

Constraining patent/regulatory exclusivity:

9,351,923

Dosage:

FOR SUSPENSION;INTRAMUSCULAR

^*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.

Anatomical Therapeutic Chemical (ATC) Classes for PASIREOTIDE PAMOATE

H01CB	Somatostatin and analogues
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for PASIREOTIDE PAMOATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014		RX	Yes	No	9,351,923		Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014		RX	Yes	No	7,759,308		Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-004	Jun 29, 2018		RX	Yes	No	7,759,308		Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014		RX	Yes	Yes	7,473,761		Y	Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014		RX	Yes	No	9,351,923		Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-004	Jun 29, 2018		RX	Yes	No	9,351,923		Y
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-005	Jun 29, 2018		RX	Yes	No	7,759,308		Y

Expired US Patents for PASIREOTIDE PAMOATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014	8,822,637
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014	6,225,284
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014	8,822,637
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-003	Dec 15, 2014	6,225,284
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-002	Dec 15, 2014	6,225,284
Recordati Rare	SIGNIFOR LAR KIT	pasireotide pamoate	FOR SUSPENSION;INTRAMUSCULAR	203255-001	Dec 15, 2014	8,822,637

International Patents for PASIREOTIDE PAMOATE

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0112859	análogos de somatostatina, composição farmacêutica, bem como uso dos referidos análogos
Poland	1686964
Mexico	PA03000991	ANALOGOS DE SOMATOSTATINA. (SOMATOSTATIN ANALOGUES.)
Austria	455537
Russian Federation	2404749	МИКРОЧАСТИЦЫ, СОДЕРЖАЩИЕ АНАЛОГИ СОМАТОСТАТИНА (MICROPARTICLES CONTAINING ANALOGS OF SOMATOSTATIN)
Georgia, Republic of	P20125582	EXTENDED-RELEASE COMPOSITION COMPRISING SOMATOSTATIN DERIVATIVE IN MICROPARTICLES
Poland	204161

Supplementary Protection Certificates for PASIREOTIDE PAMOATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1307486	2012/027	Ireland		PRODUCT NAME: PASIREOTIDE OR A SALT OR COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/12/753/001-EU/1/12/753/012 20120424
1307486	SPC/GB12/030	United Kingdom		PRODUCT NAME: CYCLO((4R)-4-(2-AMINOETHYLCARBAMOYLOXY)-L-PROLYL-L-PHENYLGLYCYL-D-TRYPTOPHYL-L-LYSYL-4-O-BENZYL-L-TYROSYL-L-PHENYLALANYL-)), PASIREOTIDE, OR SALTS THEREOF; REGISTERED: UK EU/1/12/753/001-012 20120424
1307486	12C0041	France		PRODUCT NAME: CYCLO((4R)-4(2-AMINOETHYLCARBAMOYLOXY)-L-PROLYL-L-PHENYLGLYCYL-D-TRYPTOPHYL-L-LYSYL-4-O-BENZYL-L-TYROSYL-L-PHENYLALANYL-) : PASIREOTIDE, OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/12/753/001 20120424
1686964	15/2015	Austria		PRODUCT NAME: PASIREOTID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/12/753/001-017 IDF DER ENTSCHEIDUNG DER KOMMISSION C (2014) 8916 20141119
1686964	197 5005-2015	Slovakia		PRODUCT NAME: PASIREOTID ALEBO JEHO FARMACEUTICKY PRIJATEL- NA SOL ALEBO AKYKOLVEK JEHO HYDRAT; REGISTRATION NO/DATE: EU/1/12/753/001 - EU/1/12/753/017 20141119
1307486	CA 2012 00024	Denmark
1686964	PA2015009	Lithuania		PRODUCT NAME: PASIREOTIDUM; REGISTRATION NO/DATE: EU/1/12/753/13 - EU/1/12/753/17 20141119

PASIREOTIDE PAMOATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pasireotide Pamoate

Introduction

Pasireotide pamoate, marketed as Signifor, is a synthetic long-acting cyclic hexapeptide with somatostatin-like activity, primarily used in the treatment of Cushing's disease and acromegaly. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, healthcare providers, and patients.

Clinical Benefits and Market Need

Pasireotide pamoate addresses a significant clinical need by providing effective treatment for rare and debilitating conditions. For instance, in acromegaly, it helps normalize growth hormone (GH) levels, reducing the risk of chronic comorbidities such as hypertension, cardiac dysfunction, and diabetes[3].

Pricing Factors

The pricing of pasireotide pamoate is influenced by several interdependent factors:

• Clinical and Economic Value: The drug's ability to improve patient outcomes and reduce long-term healthcare costs is a key consideration[1].
• Production and Research Costs: High development and manufacturing costs are factored into the pricing strategy[1].
• Market Dynamics: Competitor pricing, market demand, and the overall therapeutic landscape play significant roles[1].
• Regulatory and Reimbursement Environment: Government rebates, commercial discounts, and patient support programs also impact pricing decisions[1].

Price Increases and Justifications

Recent data indicates that pasireotide pamoate has experienced price increases, often justified by rising operational costs and inflation.

• Inflation and Operational Costs: Companies like BIOCODEX INC have cited inflation and escalating operational costs as reasons for a 15% price increase in the last calendar year[1].
• Annual Adjustments: Some pharmaceutical companies, such as CMP Pharma, adjust prices annually to keep up with inflation and rising costs[1].

Budget Impact Analysis

The introduction of pasireotide pamoate into healthcare systems has been analyzed for its budget impact:

• Modest Budget Impact: Studies suggest that the budget impact of pasireotide LAR (long-acting release) is modest, with an estimated increase of 1.42 cents per member per month (PMPM) in the third year following FDA approval[3].
• Cost Savings: Effective treatment with pasireotide LAR can lead to significant cost savings from reduced comorbidities, estimated at $10,240 per year per patient achieving disease control[3].

Economic Models and Sensitivity Analysis

Economic models have been developed to assess the budget impact from different perspectives:

• Health Plan Perspective: Models include costs of drug therapies, treatment monitoring, management of adverse events, and comorbidities. The pharmacy cost calculator focuses solely on drug costs[3].
• Sensitivity Analysis: The economic model for pasireotide is sensitive to treatment response and costs of alternative treatments. For example, changes in the probability of achieving full biochemical control can significantly impact the Incremental Cost-Effectiveness Ratio (ICER)[2].

Market Uptake and Patient Eligibility

The market uptake of pasireotide pamoate is influenced by patient eligibility and treatment adherence:

• Patient Eligibility: Estimates suggest that there are a limited number of patients eligible for treatment, with an expected increase in treatment uptake over the years. For instance, in Scotland, the estimated number of patients treated with pasireotide increased from 8 in the first year to 46 in the fifth year[2].
• Budget Impact: The gross medicines budget impact is estimated to increase from £229k in the first year to £1.4m in the fifth year, though the net impact is lower due to the displacement of other medicines[2].

Regulatory Approvals and Recommendations

Pasireotide pamoate has received regulatory approvals and recommendations based on its clinical and economic benefits:

• Scottish Medicines Consortium (SMC): The SMC accepted pasireotide for use in NHS Scotland, considering its potential to bridge to definitive therapy and the greater uncertainty accepted for ultra-orphan medicines[2].

Patient and Public Involvement

Patient groups have provided valuable insights into the benefits and challenges of pasireotide pamoate:

• Patient Group Submissions: Organizations like The Pituitary Foundation have submitted feedback highlighting the impact of effective treatment on patients' quality of life and financial well-being[2].

Financial Projections and Cost Considerations

Financial projections for pasireotide pamoate involve careful consideration of various cost factors:

• Drug Costs: The cost of pasireotide pamoate itself is a significant component, with prices ranging widely depending on the formulation and dosage[1].
• Comorbidity Costs: The reduction in comorbidity costs due to effective treatment is a crucial factor in the overall financial trajectory[3].

Conclusion

Pasireotide pamoate's market dynamics and financial trajectory are shaped by its clinical benefits, production costs, market competition, and regulatory environment. While the drug's introduction may result in a modest increase in healthcare budgets, it offers significant long-term cost savings and improved patient outcomes.

Key Takeaways

• Clinical Benefits: Pasireotide pamoate effectively treats rare conditions like Cushing's disease and acromegaly.
• Pricing Factors: Pricing is influenced by clinical value, production costs, market dynamics, and regulatory factors.
• Budget Impact: The budget impact is modest, with potential long-term cost savings.
• Regulatory Approvals: The drug has received approvals based on its clinical and economic benefits.
• Patient Impact: Effective treatment improves quality of life and reduces financial burdens on patients.

FAQs

Q: What is pasireotide pamoate used for? A: Pasireotide pamoate is used in the treatment of Cushing's disease and acromegaly.

Q: What factors influence the pricing of pasireotide pamoate? A: Pricing is influenced by clinical benefits, production costs, market dynamics, competitor pricing, and regulatory factors.

Q: How does pasireotide pamoate impact healthcare budgets? A: The drug has a modest budget impact, with an estimated increase of 1.42 cents PMPM in the third year following FDA approval.

Q: What are the long-term cost savings associated with pasireotide pamoate? A: Effective treatment can lead to significant cost savings from reduced comorbidities, estimated at $10,240 per year per patient.

Q: Has pasireotide pamoate received regulatory approvals? A: Yes, it has been approved by regulatory bodies such as the Scottish Medicines Consortium (SMC) for use in NHS Scotland.

Sources

1. 2024 Price Increase Report - Texas Department of State Health Services
2. SMC No. (1048/15) - Scottish Medicines Consortium
3. Budget impact of pasireotide LAR for the treatment of acromegaly - PubMed
4. Pasireotide pamoate | DrugBank Online - DrugBank