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
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004		DISCN	Yes	No	9,375,405		Y
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	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	021688-003	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
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004	6,313,146

International Patents for SENSIPAR

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	545498	Rapid dissolution formulation of a calcium receptor-active compound
Spain	2737348
World Intellectual Property Organization (WIPO)	9511221
China	1946382	Rapid dissolution formulation of a calcium receptor-active compound
Germany	69533948
Israel	122958	METHOD OF IDENTIFYING A CALCIMIMETIC COMPOUND
Taiwan	568896

Supplementary Protection Certificates for SENSIPAR

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	300199	Netherlands
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	CA 2005 00027	Denmark
1203761	SPC020/2005	Ireland		SPC020/2005: 20060407, EXPIRES: 20191021
1203761	C01203761/01	Switzerland		PRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004
1203761	91182	Luxembourg		91182, EXPIRES: 20191022

Market Dynamics and Financial Trajectory for SENSIPAR

Last updated: November 20, 2025

Introduction

SENSIPAR (cinacalcet hydrochloride) is a pharmaceutical agent developed by Amgen Inc., primarily indicated for secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on dialysis and hypercalcemia in patients with parathyroid carcinoma. Since its FDA approval in 2004, SENSIPAR has played a pivotal role in managing mineral and bone disorders associated with CKD, with potential applications expanding amidst evolving markets, regulatory shifts, and competitive dynamics. This report rigorously examines the current market forces, competitive landscape, pipeline opportunities, regulatory considerations, and financial projections that shape SENSIPAR’s future.

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Market Landscape and Drivers

1. Prevalence of Target Conditions

The global CKD population exceeds 850 million individuals, with approximately 10-15% affected by advanced stages requiring dialysis or transplant (WHO, 2022). The prevalence of secondary hyperparathyroidism correlates strongly with CKD progression, affecting over 70% of dialysis patients. The surge in CKD prevalence accelerates demand for effective management options such as SENSIPAR.

2. Therapeutic Positioning

SENSIPAR’s mechanism—parathyroid hormone regulation via calcium-sensing receptor modulation—addresses unmet needs in hyperparathyroidism management, especially in refractory cases. While traditional therapies include vitamin D analogs and phosphate binders, SENSIPAR offers a targeted, potent option, driving adoption in specific patient populations.

3. Market Penetration and Adoption Trends

Despite its efficacy, SENSIPAR faces barriers including high cost, particular side-effect profiles (e.g., hypocalcemia), and competition from emerging therapies. Its utilization remains closely tied to insurance reimbursement policies and physician familiarity, impacting sales trajectory.

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Competitive Environment

1. Existing Competitors

• Phosphate Binders and Vitamin D Analogs: Standard adjunct therapies with widespread use but limited specificity.
• Emerging Calcimimetics: Companies such as reducible to subsequent generics or novel agents with improved safety profiles. AbbVie’s cinacalcet remains a branded standard, but generic versions are available, exerting price competition.

2. Pipeline and New Entrants

Innovations focus on gene therapy, monoclonal antibodies, and advanced calcimimetics aiming for fewer side effects and improved compliance. The competitive pressure from these modalities influences SENSIPAR’s market share and pricing power, especially as patent exclusivity phases out.

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Regulatory and Reimbursement Dynamics

1. Patent and Exclusivity

Amgen’s patent for SENSIPAR is set to expire in 2028, creating imminent generic entry risks. This forecast mandates strategic moves such as lifecycle management and label expansions.

2. Regulatory Approvals and Data

Ongoing clinical trials evaluating SENSIPAR’s efficacy in hypercalcemia due to other causes (e.g., parathyroid carcinoma) could broaden its indications, favorably impacting the financial outlook.

3. Reimbursement Trends

Insurance coverage and national health systems heavily influence prescription volumes. Governments are increasingly scrutinizing drug prices, pressing pharmaceutical companies for cost-effective therapies, substantially affecting SENSIPAR’s revenue potential.

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Financial Trajectory Analysis

1. Historical Performance

Amgen's SENSIPAR generated approximately $0.8 billion in annual revenues (FY2022), representing a stable, though plateaued, growth pattern over recent years. Reimbursement challenges and patent expirations have suppressed aggressive growth.

2. Future Revenue Forecasts

Assuming stabilization, generic entry in 2028 could precipitate a 60-80% decline in brand-name sales within 2-3 years post-patent expiry, aligning with historical patterns of biologic and small molecule fates. To counteract this decline, Amgen may leverage:

• Label expansion to new indications such as non-dialysis CKD patients.
• Geographic expansion into emerging markets with rising CKD prevalence.
• Pipeline integration, including potential biosimilars or combination therapies.

3. Strategic Initiatives and Growth Levers

• Investing in clinical trials for new indications, e.g., hypercalcemia of malignancy.
• Developing next-generation calcimimetics with enhanced safety profiles.
• Engaging in partnerships for biosimilar development to extend lifecycle.

4. Financial Modeling

• Pre-Patent Expiry (2023-2028): Revenues maintained with moderate growth, primarily driven by expanding indications and geographic reach.
• Post-Patent Expiry (2028 onwards): Revenue decline projected, with rapid depreciation unless mitigated through lifecycle management strategies.
• Potential Upsides: Successful market expansion, pipeline approvals, and strategic collaborations could cushion revenue drops.

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Long-term Outlook and Key Risks

While SENSIPAR currently maintains a critical niche, risks from patent expiration, increasing market competition, and reimbursement pressure remain significant. The drug’s future financial trajectory depends heavily on Amgen’s strategic responses, including pipeline innovation, indication expansion, and cost management.

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Key Takeaways

• The global CKD burden positions SENSIPAR as a key therapeutic agent, but impending patent expiry necessitates strategic planning.
• Market growth is driven by rising CKD prevalence; however, price competition and generic entry threaten revenues.
• Diversification via label expansion and pipeline development offers pathways to sustain long-term growth.
• Regulatory, reimbursement, and geopolitical factors significantly influence sales trajectories.
• Amgen’s proactive lifecycle management and innovation are vital to maintaining profitability beyond 2028.

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FAQs

1. When will generic versions of SENSIPAR enter the market, and how will they impact revenues?
Generic cinacalcet is expected around 2028, coinciding with patent expiry. Historically, generic entry leads to substantial revenue erosion—potentially 60-80% within a few years unless mitigated by new indications or formulations.

2. Are there any ongoing clinical trials that could expand SENSIPAR’s approved uses?
Yes. Recent trials are exploring SENSIPAR’s efficacy in hypercalcemia related to parathyroid carcinoma and other off-label indications, which could broaden its commercial applicability.

3. How does reimbursement influence SENSIPAR’s sales performance?
Reimbursement policies directly affect patient access and physician prescribing behaviors. Variability across regions can significantly impact sales, especially in price-sensitive markets.

4. What strategic measures can Amgen undertake post-patent expiry to sustain revenue?
Amgen can pursue lifecycle management via label extensions, develop biosimilars, enter into licensing agreements, or innovate new calcimimetic compounds with improved profiles.

5. How does SENSIPAR compare with emerging therapies for hyperparathyroidism?
Emerging therapies, including novel calcimimetics and biologics, aim for fewer side effects and easier administration. Their success could further challenge SENSIPAR’s market dominance, emphasizing the need for continual innovation and differentiation.

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References

[1] World Health Organization. (2022). Global prevalence of chronic kidney disease.
[2] Amgen Inc. Annual Report 2022.
[3] FDA. (2004). Approval for cinacalcet hydrochloride (SENSIPAR).
[4] MarketResearch.com. (2022). CKD therapeutics market analysis.
[5] IQVIA. (2023). Global pharmaceutical sales and pipeline updates.