SENSIPAR Drug Patent Profile

When do Sensipar patents expire, and what generic alternatives are available?

Sensipar is a drug marketed by Amgen and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-one patent family members in twenty-nine countries.

The generic ingredient in SENSIPAR is cinacalcet hydrochloride. There are twenty-four drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the cinacalcet hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sensipar

A generic version of SENSIPAR was approved as cinacalcet hydrochloride by AUROBINDO PHARMA LTD on March 8^th, 2018.

Summary for SENSIPAR

International Patents:	81
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	17
Patent Applications:	352
Drug Prices:	Drug price information for SENSIPAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SENSIPAR
What excipients (inactive ingredients) are in SENSIPAR?	SENSIPAR excipients list
DailyMed Link:	SENSIPAR at DailyMed

See drug prices for SENSIPAR

Recent Clinical Trials for SENSIPAR

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

Sponsor	Phase
VA Office of Research and Development	Phase 4
University of California, San Francisco	Phase 4
Peter Vestergaard	Phase 3

See all SENSIPAR clinical trials

Pharmacology for SENSIPAR

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

Paragraph IV (Patent) Challenges for SENSIPAR

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 SENSIPAR

SENSIPAR is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004		DISCN	Yes	No	7,829,595		Y
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004		DISCN	Yes	No	9,375,405		Y
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004		DISCN	Yes	No	9,375,405		Y
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004		DISCN	Yes	No	7,829,595		Y

Expired US Patents for SENSIPAR

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

International Patents for SENSIPAR

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

Country	Patent Number	Title	Estimated Expiration
Canada	2115828	MOLECULES ACTIVES POUR LA RECEPTION DU CALCIUM (CALCIUM RECEPTOR ACTIVE MOLECULES)
Brazil	9509411
Hungary	0700718
Brazil	9408298

Supplementary Protection Certificates for SENSIPAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1203761	SPC020/2005	Ireland		SPC020/2005: 20060407, EXPIRES: 20191021
1203761	CA 2005 00027	Denmark
1203761	91182	Luxembourg		91182, EXPIRES: 20191022
1203761	C01203761/01	Switzerland		PRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004

Market Dynamics and Financial Trajectory of Sensipar (Cinacalcet)

Last updated: December 12, 2025

Executive Summary

Sensipar (generic name: Cinacalcet) is a calcimimetic agent approved primarily for secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) patients on dialysis, and parathyroid carcinoma-related hypercalcemia. Since its FDA approval in 2004, Sensipar has become a cornerstone treatment within its niche, influencing the broader market landscape centered around secondary hyperparathyroidism and related disorders.

This report explores the market dynamics shaping Sensipar's commercial landscape, the factors influencing its financial trajectory, competitive positioning, and future growth prospects. Integrating data from leading industry reports, regulatory updates, and patent developments, the analysis offers strategic insights for stakeholders conjugating pharmaceutical innovation, market access, and commercial deployment.

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Market Overview

1. Therapeutic Indication and Patient Population

Primary Indications:

• Secondary hyperparathyroidism in CKD patients on dialysis.
• Parathyroid carcinoma-associated hypercalcemia.

Market Size & Patient Demographics:

• Estimated global CKD population (~850 million globally as per WHO, 2022) indicates substantial potential.
• Approximate dialysis patients: ~4.7 million globally, with numbers rising annually (Global Dialysis Market, 2023).
• SHPT prevalence among dialysis patients: estimated at 70-85% (KDIGO guidelines, 2017).

Market Penetration:

• Restricted initially due to the narrow scope, with an increasing trend driven by rising CKD prevalence.

2. Regulatory Landscape & Approvals

• FDA approval in 2004; subsequent approvals in the EU (2004), Japan, and emerging markets.
• Extended indications: Post-approval clinical data supported on-label use in hypercalcemia due to parathyroid carcinoma.

3. Competitive Environment

Company	Drug	Year of Approval	Market Share (2022)	Notes
Amgen	Sensipar (Cinacalcet)	2004	Estimated 85%	Dominant player, patent protections active until 2028
Klobbi (etelcalcetide)	Etelcalcetide	2017	~15%	Injectable calcimimetic for dialysis patients, competing with Sensipar
Others	Off-label calcimimetics	Minimal	N/A	Limited due to efficacy and safety concerns

Note: Amgen's patent estate expiring around 2028–2029, potentially opening market share to generics.

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Market Dynamics Influencing Sensipar

4. Patent Lifecycle & Generic Entry

• Patents protecting Sensipar’s core formulation expire between 2028-2029.
• Patent cliff anticipated to trigger generic competition, reducing prices and impacting revenue.
• Launch readiness of generics depends on regulatory approvals, manufacturing capabilities, and market acceptance.

5. Pricing and Reimbursement Trends

Region	Pricing Strategies	Reimbursement Policies	Trends
U.S.	Negotiated DRG/Part D formulary placements	CMS reimbursement models favor cost-effective treatments	Increasing emphasis on value-based pricing
EU	Price negotiations vary by country; Managed entry agreements common	Reimbursement limited to approved indications	Shift towards medicines with demonstrated cost-effectiveness
Emerging Markets	Price sensitivity dominant	Reimbursement less structured	Price-based competition intensifies

6. Volume Drivers and Patient Access

• Growth driven by increasing CKD and dialysis rates.
• Expanded use in hypercalcemia management, especially in parathyroid carcinoma.
• Educational outreach by nephrology societies boosts adoption.
• COVID-19 pandemic delayed some treatment initiation but recovery is underway.

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Financial Trajectory Analysis

7. Revenue Trend and Projections

Year	Estimated Global Revenue	Growth Rate (2019–2022)	Key Factors
2019	~$600 million	—	Solid market penetration
2020	~$610 million	+1.7%	Pandemic impact mitigated by chronic disease management necessity
2021	~$620 million	+1.6%	Increasing CKD prevalence
2022	~$630 million	+1.6%	Market stabilization

Forecasts:

Year	Projection	Assumptions
2023	~$640 million	Continued rise in CKD, stable pricing, limited generic impact
2024	~$620 million	Early generic entries reduce revenues
2028	~$200 million	Patent expiry, market erosion, generic penetration
2030	<$150 million	Dominance of generics, potential value-based pricing reductions

8. Cost Structures & Profitability

• R&D investment recouped early; ongoing costs include manufacturing, marketing, regulatory compliance.
• Gross margins estimated at ~80%, margins potentially compressed post-generic entry.
• R&D and patent litigation costs influence pricing strategies.

9. Strategic Factors Influencing Future Financials

• Patent Litigation & Defenses: Ongoing patent infringement suits delay generic entry; successful defenses extend revenue streams.
• Pipeline & Formulation Innovations: New formulations (e.g., extended-release versions) could reopen revenue growth even as patent expires.
• Global Market Expansion: Entry into emerging markets via partnerships could buffer revenue decline.

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Comparative Evaluation of Market Strategies

Aspect	Sensipar (Amgen)	Competitors	Opportunities	Threats
Patent Portfolio	Strong, expiring 2028-2029	None yet	Maintain market share until patent expiry	Patent expiry demands innovation
Pricing	Premium at launch	Competitive pricing post-generic	Leverage brand loyalty	Price erosion from generics
Market Penetration	High in dialysis centers	Lower in non-dialysis indications	Expand indications and use cases	Competition from injectable calcimimetics
R&D Focus	Formulation improvements	Next-generation calcimimetics	Develop oral formulations with improved efficacy	Regulatory hurdles

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Future Outlook and Growth Drivers

Factor	Impact	Status	Strategic Implications
Patent Expiry	Revenue decline	2028–2029	Need for pipeline diversification
Generics Entry	Price erosion	Imminent	Innovations to extend patent life or expand indications
Market Expansion	Revenue growth	Asia, Africa	Partnership and registration strategies
Indication Expansion	Market growth	Hypercalcemia, off-label uses	Clinical trials for additional indications
Digital & Precision Medicine	Competitive advantage	Emerging	Investment in personalized treatments

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Conclusion: Navigating Sensipar's Financial Trajectory

Sensipar's dominant position in the treatment of secondary hyperparathyroidism has sustained its revenue momentum for nearly two decades. However, impending patent expiration necessitates proactive strategies including pipeline innovation, indication expansion, and potential value-based pricing models. Market access, especially in emerging regions, offers growth potential, whereas competitive dynamics from injectable calcimimetics and emerging oral alternatives compound the need for differentiation.

Stakeholders should focus on safeguarding patent rights through litigations, innovating formulations, and exploring biosimilars where applicable. The era beyond patent expiry will demand agility, with profitability increasingly reliant on cost management and strategic global positioning.

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Key Takeaways

• Market Maturity & Patent Risks: Sensipar’s revenue peaks prior to patent expiry in 2028–2029; commercialization strategies must adapt accordingly.
• Pipeline & Innovation Opportunities: Developing new formulations, expanding indications, and embracing digital health could extend product life.
• Competitive & Pricing Pressures: Generic competition will drive pricing down, emphasizing the importance of patent enforcement and value demonstration.
• Global Market Expansion: Emerging markets present significant growth avenues, especially where CKD awareness and treatment access are evolving.
• Strategic Investments: R&D, legal defenses, and market access initiatives are essential to maintain profitability through the transition.

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FAQs

Q1: When are the patent protections for Sensipar expected to expire?
A1: The primary patents for Sensipar (Cinacalcet) are projected to expire around 2028–2029, after which generic manufacturers can seek regulatory approval.

Q2: What therapeutic alternatives could impact Sensipar’s market share?
A2: The primary competitors include injectable calcimimetic etelcalcetide (Klobbi), off-label calcimimetics, and emerging oral or combination therapies that demonstrate comparable efficacy and safety.

Q3: How significant is the role of emerging markets in Sensipar’s future?
A3: Asia, Africa, and Latin America offer substantial growth potential due to rising CKD prevalence, increasing dialysis infrastructure, and expanding healthcare access.

Q4: Are there ongoing clinical trials that could alter the treatment landscape?
A4: Yes, current trials focus on new formulations, long-acting versions, and indications beyond CKD-related hyperparathyroidism, which could influence future positioning.

Q5: What strategies can Amgen employ to extend Sensipar’s market life?
A5: Initiatives include pipeline development, formulation innovation, expanding to new indications, securing patent protections, and strategic alliances for market access.

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References

[1] World Health Organization. (2022). Global CKD Statistics.
[2] KDIGO Clinical Practice Guidelines. (2017). Chronic Kidney Disease Mineral and Bone Disorder.
[3] Global Dialysis Market Report. (2023). MarketResearch.com.
[4] U.S. Food & Drug Administration. (2004). FDA Approval Letter for Sensipar.
[5] Amgen Investor Relations. (2022). Financial Reports and Patent Data.