Pasireotide diaspartate - Generic Drug Details

What are the generic sources for pasireotide diaspartate and what is the scope of freedom to operate?

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

Pasireotide diaspartate has eighty-seven patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for pasireotide diaspartate

International Patents:	87
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Patent Applications:	1,793
DailyMed Link:	pasireotide diaspartate at DailyMed

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

Constraining patent/regulatory exclusivity:

7,473,761

Dosage:

SOLUTION;SUBCUTANEOUS

^*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 pasireotide diaspartate

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for pasireotide diaspartate

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 diaspartate

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	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012		RX	Yes	No	8,299,209		Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012		RX	Yes	No	8,299,209		Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012		RX	Yes	No	7,473,761		Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012		RX	Yes	Yes	7,473,761		Y	Y
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012		RX	Yes	Yes	8,299,209		Y	Y

Expired US Patents for pasireotide diaspartate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012	6,225,284
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012	6,225,284
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012	6,225,284

International Patents for pasireotide diaspartate

Country	Patent Number	Title	Estimated Expiration
Czech Republic	2003288
Luxembourg	92024
Peru	20020176	ANALOGOS DE SOMATOSTATINA
Hong Kong	1057051
Canada	2416293	ANALOGUES DE SOMATOSTATINE (SOMATOSTATIN ANALOGUES)

Supplementary Protection Certificates for pasireotide diaspartate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1307486	CR 2012 00024	Denmark		PRODUCT NAME: PASIREOTID OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER PASIREOTIDDIASPARTAT; REG. NO/DATE: EU/1/12/753/001-012 20120424
1307486	92024	Luxembourg		92024, EXPIRES: 20260730
1686964	C01686964/01	Switzerland		PRODUCT NAME: PASIREOTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65148 25.02.2015
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	122012000045	Germany		PRODUCT NAME: PASIREOTID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON ODER EIN KOMPLEX HIERVON; REGISTRATION NO/DATE: EU/1/12/753/001-012 20120424

Market Dynamics and Financial Trajectory for Pasireotide Diaspartate

Introduction to Pasireotide Diaspartate

Pasireotide diaspartate, marketed under the brand name Signifor, is a somatostatin analogue (SSA) used primarily for the treatment of Cushing’s disease, a rare and debilitating condition characterized by excessive cortisol production. Here, we delve into the market dynamics and financial trajectory of this drug.

Therapeutic Area and Indications

Pasireotide diaspartate is specifically indicated for the treatment of adult patients with Cushing’s disease, particularly those for whom surgery is not an option or has not been curative, and who are inadequately controlled on other treatments[4][5].

Market Need and Patient Population

Cushing’s disease affects approximately 39 cases per million in the general population, making it a rare but significant health issue. The condition is associated with substantial healthcare costs due to the complexity of managing its symptoms and comorbidities[2].

Approval and Regulatory Status

Pasireotide diaspartate was approved by the European Medicines Agency (EMA) in 2012 for the treatment of Cushing’s disease. It was also designated as an orphan medicinal product, highlighting its importance in addressing a rare condition[4].

Pharmaceutical Formulations

Pasireotide is available in several formulations, including a subcutaneous (SC) formulation (pasireotide diaspartate) and a long-acting release (LAR) formulation (pasireotide embonate) for intramuscular injection. The LAR formulation is administered every 4 weeks, with doses ranging from 20 mg to 60 mg[4].

Budget Impact and Cost Analysis

The introduction of pasireotide into health plan formularies has been evaluated for its budget impact. Studies indicate that the inclusion of pasireotide results in a relatively small increase in both the total health plan budget and the pharmacy budget. Specifically, the estimated total budget impact is $0.0115 per-member per-month (PMPM) in the first year, increasing to $0.0184 and $0.0194 in the second and third years, respectively. From a pharmacy budget perspective, the increase is $0.0257 PMPM in the first year, $0.0363 in the second year, and $0.0360 in the third year[2].

Cost Components and Scenarios

The budget impact analysis considers various cost components, including medical procedures (such as transsphenoidal surgery and bilateral adrenalectomy), drug therapies (including pasireotide, mifepristone, and off-label treatments), monitoring, surgical complications, and comorbidities. The analysis evaluates costs from both the perspective of the entire health plan and the pharmacy budget[2].

Market Competition and Alternatives

Pasireotide competes with other somatostatin analogues and treatments for Cushing’s disease. However, its unique binding profile to somatostatin receptors and its efficacy in patients inadequately controlled by other treatments position it as a valuable option in the market[4][5].

Pricing and Reimbursement

The pricing of pasireotide diaspartate can vary by region and is influenced by reimbursement policies. In many jurisdictions, pasireotide is covered under specialized drug programs due to its orphan drug status and the critical need it addresses in treating rare conditions[1][4].

Patient and Clinician Perspectives

From a patient perspective, pasireotide offers a significant improvement in quality of life by effectively controlling cortisol levels and managing symptoms of Cushing’s disease. Clinicians appreciate its efficacy and the flexibility of its dosing regimens, which can be tailored to individual patient needs[4].

Financial Projections and Growth Potential

Given the small but significant impact on health plan budgets and the critical need it addresses, pasireotide diaspartate is expected to maintain a stable market presence. The drug’s growth potential is tied to its ability to provide effective treatment for patients with Cushing’s disease, particularly in cases where other treatments have failed.

Challenges and Limitations

The market dynamics for pasireotide diaspartate are influenced by several challenges, including the limited body of literature available for Cushing’s disease, which can affect model inputs and budget impact analyses. Additionally, the drug’s use in patients with severe hepatic impairment is contraindicated, which can limit its market reach[2][4].

Conclusion

Pasireotide diaspartate plays a crucial role in the treatment of Cushing’s disease, offering a valuable therapeutic option for patients with limited alternatives. While its introduction into health plan formularies results in a small increase in costs, the overall impact is manageable, and the drug’s efficacy justifies its inclusion.

Key Takeaways

• Therapeutic Indication: Pasireotide diaspartate is primarily used for treating Cushing’s disease.
• Market Need: The drug addresses a rare but significant health issue with substantial healthcare costs.
• Regulatory Status: Approved by the EMA in 2012 and designated as an orphan medicinal product.
• Budget Impact: Small increase in both total health plan and pharmacy budgets.
• Pricing and Reimbursement: Varies by region, often covered under specialized drug programs.
• Growth Potential: Tied to its efficacy in treating Cushing’s disease, particularly in cases where other treatments have failed.

FAQs

What is pasireotide diaspartate used for?

Pasireotide diaspartate is used for the treatment of Cushing’s disease, particularly in adult patients for whom surgery is not an option or has not been curative, and who are inadequately controlled on other treatments.

How does pasireotide diaspartate affect health plan budgets?

The introduction of pasireotide diaspartate results in a relatively small increase in both the total health plan budget and the pharmacy budget, with estimated increases ranging from $0.0115 to $0.0360 PMPM over three years.

What are the different formulations of pasireotide?

Pasireotide is available in a subcutaneous (SC) formulation (pasireotide diaspartate) and a long-acting release (LAR) formulation (pasireotide embonate) for intramuscular injection.

Is pasireotide diaspartate covered by reimbursement programs?

Yes, pasireotide diaspartate is often covered under specialized drug programs due to its orphan drug status and the critical need it addresses in treating rare conditions.

What are the contraindications for pasireotide diaspartate?

Pasireotide diaspartate should not be used in patients with severe hepatic impairment.

Sources

1. CDA-AMC - Canada's Drug Agency: Pasireotide diaspartate.
2. PubMed: Budget impact of pasireotide for the treatment of Cushing's disease.
3. Journal of Biomolecular Screening: Are GPCRs Still a Source of New Targets?
4. European Medicines Agency: Signifor, INN-pasireotide - EPAR Assessment Report.
5. Therapeutic Goods Administration: Extract from the Clinical Evaluation Report for Pasireotide (as diaspartate).