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, Piramal, Rising, 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. Sixteen 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:	16
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	64
Patent Applications:	580
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
Shaanxi Micot Pharmaceutical Technology Co., Ltd.	PHASE3
Tanta University	PHASE4
Shanghai Hengrui Pharmaceutical Co., Ltd.	Phase 2

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
Alkem Labs Ltd	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	210570-003	May 17, 2019	AB	RX	No	No
Lupin Ltd	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	210548-002	Jun 28, 2019		DISCN	No	No
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004		DISCN	Yes	No	9,375,405		Y
Strides Pharma	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	209226-001	Apr 30, 2018	AB	RX	No	No
Accord Hlthcare	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	211892-002	May 15, 2020	AB	RX	No	No
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004		DISCN	Yes	No	9,375,405		Y

Expired US Patents for CINACALCET HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004	6,211,244
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004	6,011,068
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004	6,313,146
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004	6,011,068
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004	6,031,003
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004	6,011,068

International Patents for CINACALCET HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Spain	2812198
Turkey	201909267
Brazil	PI0414254	composição farmacêutica, e, métodos para fabricar uma composição farmacêutica, para o tratamento de pelo menos uma doença e para controlar a taxa de dissolução de uma formulação
Eurasian Patent Organization	013425	БЫСТРОРАСТВОРИМАЯ ЛЕКАРСТВЕННАЯ ФОРМА СОЕДИНЕНИЯ, ДЕЙСТВУЮЩЕГО НА КАЛЬЦИЕВЫЙ РЕЦЕПТОР (RAPID DISSOLUTION FORMULATION OF A CALCIUM RECEPTOR-ACTIVE COMPOUND)
Spain	2655435
Poland	2821067

Supplementary Protection Certificates for CINACALCET HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1203761	05C0029	France		PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
1203761	C01203761/01	Switzerland		PRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004
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

Market Dynamics and Financial Trajectory for Cinacalcet Hydrochloride: A Comprehensive Analysis

Last updated: July 27, 2025

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Introduction

Cinacalcet hydrochloride, marketed primarily under the brand name Sensipar or Mimpara, is a calcimimetic agent developed to manage secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) patients on dialysis, as well as parathyroid carcinoma-related hypercalcemia. Since its FDA approval in 2004, the drug has played a pivotal role in treating mineral bone disorders associated with CKD and certain hypercalcemia conditions. This analysis delineates the market dynamics, competitive landscape, regulatory influences, and projected financial trajectory of cinacalcet hydrochloride, offering critical insights for stakeholders.

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Market Overview and Demand Drivers

The global demand for cinacalcet hydrochloride is primarily driven by the rising prevalence of CKD, particularly in aging populations and regions facing increased incidence of diabetes and hypertension—conditions that predispose individuals to CKD. According to the Global Burden of Disease Study, CKD affects approximately 700 million people worldwide, with numbers projected to rise due to lifestyle factors and aging demographics [1].

Secondary hyperparathyroidism afflicts a substantial proportion of dialysis patients—estimates suggest that nearly 60-80% develop SHPT, making calcimimetics a cornerstone therapy. Given the limited alternatives and the lack of highly efficacious oral medications, cinacalcet’s role remains central, ensuring consistent demand.

In addition to CKD-related hyperparathyroidism, cinacalcet is indicated for parathyroid carcinoma-associated hypercalcemia, particularly in cases refractory to conventional therapy. Off-label interest in its calcimimetic properties continues to grow, although regulatory approval remains specific.

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Market Dynamics

1. Competitive Landscape

Since its initial entry, cinacalcet has faced competition primarily from surgical parathyroidectomy, vitamin D analogs, and newer calcimimetics like etelcalcetide, approved in 2017 by the FDA for similar indications. The emergence of etelcalcetide, administered intravenously, offers therapeutic advantages, including reduced pill burden and improved compliance, especially in hemodialysis settings.

Key players include pharmaceutical giants such as Amgen, which developed cinacalcet, with other biotech firms exploring alternative calcimimetic agents. Patent expirations and generic entry are anticipated to influence pricing and overall market share, although stringent quality controls and clinical preferences favor branded formulations in certain regions.

2. Regulatory Environment

Regulatory frameworks considerably impact cinema’s market, with approvals contingent upon demonstrating efficacy and safety. The drug's patent life, which began in the early 2000s, faced expiration in the United States around 2017 for some formulations, opening avenues for biosimilars and generics, thereby influencing pricing and competition.

Regulatory hurdles in emerging markets, including India and China, shape access and availability. Governments emphasizing cost-effective therapies may favor generic substitutes, exerting downward pressure on prices.

3. Pricing and Reimbursement Policies

Pricing strategies for cinacalcet vary regionally, often influenced by healthcare reimbursement policies. In developed markets like the U.S., insurance coverage and Medicare reimbursements support sustained sales, although pricing pressures are mounting. Conversely, low- and middle-income nations may rely heavily on generic versions, affecting profitability.

Reimbursement status significantly impacts market adoption—coverage by major insurers enhances uptake, whereas lack thereof hinders broader dissemination.

4. Innovations and Pipeline Developments

While cinacalcet remains the flagship calcimimetic, ongoing research aims to develop more selective agents with improved safety profiles and fewer drug interactions. The advent of injectable calcimimetics like etelcalcetide positions the market for a strategic shift toward combination therapies and alternative delivery modalities.

The drug’s existing safety profile, with concerns such as hypocalcemia, necessitates ongoing pharmacovigilance, influencing both physician prescribing habits and regulatory scrutiny.

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Financial Trajectory

1. Revenue Trends

Amgen's initial blockbuster success positioned cinacalcet as a significant revenue generator, with peak global sales exceeding USD 1.2 billion in 2014. However, subsequent patent expirations, coupled with increased generic competition, precipitated sales declines, with revenues in recent years stabilizing around USD 600-700 million (2021 data).

Regional markets display divergent growth patterns: North America maintains high revenues owing to advanced healthcare infrastructure and high incidence of CKD. Conversely, emerging markets are experiencing growth due to expanding dialysis services and improved healthcare access.

2. Pricing and Market Penetration

Post-patent expiration, generic versions have entered markets at substantially reduced prices—up to 80% lower than branded formulations—leading to increased accessibility but decreased profit margins for originators. Strategic partnerships, value-based pricing, and formulation improvements serve as potential mitigators against revenue erosion.

3. Future Revenue Projections

Based on epidemiological trends and therapeutic dominance, the global cinacalcet market is expected to decline modestly over the next five years due to generic competition. However, demand stabilization in clinical niches, coupled with potential new indications and expanded access in low-income countries, might offset some revenue attrition.

Alternative calcimimetics and pharmacological advancements could further challenge cinacalcet’s market share. Nonetheless, its entrenched position and ongoing formulations suggest a gradual decline rather than a sharp obsolescence.

4. Impact of Emerging Markets and Healthcare Policies

Countries like India and China are expanding dialysis infrastructure and CKD awareness, fostering market growth opportunities. Additionally, government policies favoring price controls and domestic manufacturing may influence pricing strategies and profit margins.

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Strategic Outlook and Investment Considerations

While revenue growth faces headwinds from patent expirations and market saturation, strategic positioning—through innovation in formulations, expansion into emerging markets, and pipeline diversification—can sustain profitability. Mergers, acquisitions, and licensing agreements serve as key tactics for market players aiming to bolster their portfolio.

Investors evaluating cinacalcet’s prospects should consider regulatory trajectories, patent landscapes, competitive innovations, and country-specific healthcare policies. The emergence of alternative calcimimetic agents and biosimilars remains a significant factor shaping future financial performance.

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Key Takeaways

• Growing CKD Incidence Drives Demand: The increasing global burden of CKD sustains high demand for calcimimetics like cinacalcet, especially in dialysis-dependent populations.

• Patent Expirations and Generics Impact Revenue: Patent lapses have introduced generics, leading to price reductions and market share redistribution, particularly in cost-sensitive markets.

• Competition from New Agents: The approval of etelcalcetide and other future calcimimetics presents competitive threats and opportunities for differentiation.

• Regional Market Dynamics Vary: Developed regions favor branded formulations with reimbursement support, whereas emerging markets favor low-cost generics, influencing revenue diversification.

• Innovation and Pipeline Development Are Critical: Ongoing research into safer, more effective calcimimetics determines long-term market sustainability.

• Regulatory and Policy Risks: Pricing regulations, reimbursement policies, and approval processes in different countries significantly impact financial performance.

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Conclusion

Cinacalcet hydrochloride remains a vital therapeutic agent within the mineral metabolism management landscape. While current revenues stabilize amid mounting competition, market share will depend on strategic adaptation to patent expirations, pipeline innovations, and regional healthcare evolutions. Stakeholders should focus on leveraging emerging opportunities in developing markets, engaging in R&D to improve drug profiles, and navigating regulatory landscapes to ensure sustained growth.

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References

[1] GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of CKD, 1990–2019. Lancet. 2020;396(10260):1072-1090.