CINACALCET HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for cinacalcet hydrochloride and what is the scope of patent protection?

Cinacalcet hydrochloride is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Dr Reddys, Hetero Labs Ltd V, Lupin Ltd, Norvium Bioscience, Slate Run Pharma, Stevens J, Strides Pharma, Sun Pharm, Watson Labs Teva, and Amgen, and is included in fifteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cinacalcet hydrochloride has eighty-one patent family members in twenty-nine countries.

There are twenty-two drug master file entries for cinacalcet hydrochloride. Twenty suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for CINACALCET HYDROCHLORIDE

International Patents:	81
US Patents:	2
Tradenames:	2
Applicants:	15
NDAs:	15
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	62
Patent Applications:	298
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CINACALCET HYDROCHLORIDE
What excipients (inactive ingredients) are in CINACALCET HYDROCHLORIDE?	CINACALCET HYDROCHLORIDE excipients list
DailyMed Link:	CINACALCET HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CINACALCET HYDROCHLORIDE

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

Sponsor	Phase
Shanghai Hengrui Pharmaceutical Co., Ltd.	Phase 2
University of California, San Francisco	Phase 4
VA Office of Research and Development	Phase 4

See all CINACALCET HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for CINACALCET HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		90MG	TABLET; ORAL
		60MG	TABLET; ORAL
		30MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for CINACALCET HYDROCHLORIDE

Drug Class	Calcium-sensing Receptor Agonist
Mechanism of Action	Increased Calcium-sensing Receptor Sensitivity

Medical Subject Heading (MeSH) Categories for CINACALCET HYDROCHLORIDE

Calcimimetic Agents

Anatomical Therapeutic Chemical (ATC) Classes for CINACALCET HYDROCHLORIDE

H05BX	Other anti-parathyroid agents
H05B	ANTI-PARATHYROID AGENTS
H05	CALCIUM HOMEOSTASIS
H	Systemic hormonal preparations, excluding sex hormones and insulins

Paragraph IV (Patent) Challenges for CINACALCET HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SENSIPAR	Tablets	cinacalcet hydrochloride	30 mg, 60 mg and 90 mg	021688	1	2008-03-10

US Patents and Regulatory Information for CINACALCET HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cipla	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	208915-003	Mar 8, 2018	AB	RX	No	No
Cipla	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	208915-002	Mar 8, 2018	AB	RX	No	No
Alkem Labs Ltd	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	210570-001	May 17, 2019	AB	RX	No	No

Expired US Patents for CINACALCET HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004

International Patents for CINACALCET HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Germany	19164145
World Intellectual Property Organization (WIPO)	2005034928
Slovenia	2821067

Supplementary Protection Certificates for CINACALCET HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1203761	SPC/GB05/031	United Kingdom		PRODUCT NAME: CINACALCET OR A PHARMACEUTICALLY ACCEPTABLE SALT OR COMPLEX THEREOF; REGISTERED: UK EU/1/04/292/001 20041022; UK EU/1/04/292/002 20041022; UK EU/1/04/292/003 20041022; UK EU/1/04/292/004 20041022; UK EU/1/04/292/005 20041022; UK EU/1/04/292/006 20041022; UK EU/1/04/292/007 20041022; UK EU/1/04/292/008 20041022; UK EU/1/04/292/009 20041022; UK EU/1/04/292/010 20041022; UK EU/1/04/292/011 20041022; UK EU/1/04/292/012 20041022; UK EU/1/04/293/001 20041022; UK EU/1/04/293/002 20041022; UK EU/1/04/293/003 20041022; UK EU/1/04/293/004 20041022; UK EU/1/04/293/005 20041022; UK EU/1/04/293/006 20041022; UK EU/1/04/293/007 20041022; UK EU/1/04/293/008 20041022; UK EU/1/04/293/009 200410
1203761	C01203761/01	Switzerland		PRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004
1203761	05C0029	France		PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022

CINACALCET HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Cinacalcet Hydrochloride

Introduction

Cinacalcet hydrochloride, a calcimimetic agent, has been a significant player in the treatment of secondary hyperparathyroidism (SHPT) and other calcium-related disorders. Here, we delve into the market dynamics and financial trajectory of this drug, exploring its growth, applications, and economic impact.

Market Growth and Projections

The cinacalcet hydrochloride market has experienced rapid and substantial growth in recent years. Projections indicate that this expansion will continue from 2023 to 2031, driven by positive market dynamics and sustained demand[1][4].

Market Size and Segmentation

The market is segmented based on type (powder, solvent, and various dosages such as 30 mg, 60 mg, 90 mg) and application (secondary hyperparathyroidism, hypercalcemia, and others). Geographically, the market spans North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. The market size is projected to increase significantly, reaching billions of USD by 2031[1][4].

Applications and Efficacy

Cinacalcet hydrochloride is primarily used to treat secondary hyperparathyroidism in patients undergoing dialysis and hypercalcemia in patients with parathyroid carcinoma.

Secondary Hyperparathyroidism

In patients with SHPT, cinacalcet has been shown to reduce parathyroid hormone (PTH) levels and serum calcium. However, its cost-effectiveness in this context has been questioned. Studies, particularly in the Chinese healthcare setting, suggest that cinacalcet may not be cost-effective when applying a willingness-to-pay threshold of $26,508 per quality-adjusted life year (QALY)[2].

Hypercalcemia in Parathyroid Carcinoma

Cinacalcet has proven effective in reducing hypercalcemia in patients with inoperable parathyroid carcinoma. In a study involving 29 patients, cinacalcet reduced serum calcium levels by at least 1 mg/dl in 62% of the patients, offering a significant therapeutic benefit[5].

Financial Trajectory

The financial performance of cinacalcet hydrochloride is closely tied to its market demand and pricing strategies.

Pricing and Revenue

Amgen, the manufacturer of cinacalcet hydrochloride (marketed as Sensipar), has significantly increased the drug's price over the years. Since its launch in 2004, the annual cost of a typical course of Sensipar has risen from $2,956 to $9,814. This price increase has contributed substantially to Amgen's revenue, with net U.S. revenue from Sensipar rising from $36 million in 2004 to a peak of $1.4 billion in 2018[3].

Cost-Effectiveness Analysis

Despite its therapeutic benefits, the cost-effectiveness of cinacalcet remains a concern. Studies have shown that the incremental cost-effectiveness ratio (ICER) for cinacalcet can be high, often exceeding common willingness-to-pay thresholds. For instance, in the Chinese healthcare setting, the ICER was calculated to be around $44,400 per QALY gained, which is above the threshold of $26,508 per QALY[2].

Market Dynamics

Several factors influence the market dynamics of cinacalcet hydrochloride.

Drivers

• Increasing Prevalence of SHPT and Hypercalcemia: The growing number of patients with SHPT and hypercalcemia drives the demand for effective treatments like cinacalcet.
• Advancements in Healthcare: Improvements in healthcare infrastructure and access to advanced treatments contribute to the market's growth.
• Regulatory Support: Favorable regulatory environments can facilitate the approval and marketing of cinacalcet hydrochloride[1][4].

Restraints

• Cost and Cost-Effectiveness: The high cost of cinacalcet hydrochloride and its questionable cost-effectiveness in certain settings can limit its adoption.
• Competition: The presence of other treatment options and potential generic competitors can impact market share.
• Side Effects: Adverse events such as nausea, vomiting, and fractures associated with cinacalcet use can affect patient compliance and market growth[2][5].

Key Players and Competitive Landscape

Amgen is the primary manufacturer of cinacalcet hydrochloride, and its pricing strategies and market dominance play a significant role in the drug's financial trajectory. Other pharmaceutical companies may enter the market with generic versions or alternative treatments, potentially altering the competitive landscape[3].

Economic Impact

The economic impact of cinacalcet hydrochloride is multifaceted.

Revenue Generation

Cinacalcet hydrochloride has been a lucrative product for Amgen, contributing significantly to the company's revenue. The drug's high price and consistent demand have driven substantial profits[3].

Healthcare Costs

The high cost of cinacalcet hydrochloride can strain healthcare budgets, particularly in settings where it is not deemed cost-effective. This can lead to increased healthcare expenditures and potential resource allocation challenges[2].

Conclusion

The market dynamics and financial trajectory of cinacalcet hydrochloride are characterized by rapid growth, driven by increasing demand and therapeutic efficacy. However, the drug's high cost and questionable cost-effectiveness in certain contexts pose significant challenges. As the market continues to evolve, it will be important to monitor pricing strategies, regulatory changes, and the emergence of competitive treatments.

Key Takeaways

• Rapid Market Growth: The cinacalcet hydrochloride market is expected to continue its substantial growth from 2023 to 2031.
• Therapeutic Efficacy: Cinacalcet is effective in treating SHPT and hypercalcemia in parathyroid carcinoma patients.
• Cost-Effectiveness Concerns: The drug's high cost and ICER values often exceed common willingness-to-pay thresholds.
• Pricing Strategies: Amgen's pricing strategies have significantly impacted the drug's revenue and profitability.
• Economic Impact: The drug generates substantial revenue but also contributes to high healthcare costs.

FAQs

Q: What are the primary applications of cinacalcet hydrochloride?

A: Cinacalcet hydrochloride is primarily used to treat secondary hyperparathyroidism in patients undergoing dialysis and hypercalcemia in patients with parathyroid carcinoma.

Q: Is cinacalcet hydrochloride cost-effective?

A: The cost-effectiveness of cinacalcet hydrochloride is questionable, particularly in settings where the ICER exceeds common willingness-to-pay thresholds.

Q: Who is the primary manufacturer of cinacalcet hydrochloride?

A: Amgen is the primary manufacturer of cinacalcet hydrochloride, marketed as Sensipar.

Q: What are the potential side effects of cinacalcet hydrochloride?

A: Common side effects include nausea, vomiting, headache, and fracture.

Q: How has the price of cinacalcet hydrochloride changed over the years?

A: The price of cinacalcet hydrochloride has increased significantly since its launch in 2004, with the annual cost rising from $2,956 to $9,814.

Sources

1. Market Research Intellect - Global Cinacalcet Hydrochloride Market Size, Trends and Projections
2. BMJ Open - Cost-effectiveness analysis of cinacalcet for haemodialysis patients
3. House Oversight Committee - Drug Pricing Investigation
4. Market Research Intellect - Cinacalcet Hydrochloride Market Size, Scope And Forecast Report
5. Journal of Clinical Endocrinology and Metabolism - Cinacalcet Hydrochloride Reduces the Serum Calcium