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. Twenty 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:	2
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	17
Patent Applications:	153
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
University of California, San Francisco	Phase 4
VA Office of Research and Development	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	AB	RX	Yes	No			Y
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004	AB	RX	Yes	No			Y
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004	AB	RX	Yes	No			Y
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004	AB	RX	Yes	No			Y
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004	AB	RX	Yes	Yes			Y
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004	AB	RX	Yes	Yes			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
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004

International Patents for SENSIPAR

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	3395340
Slovenia	3395339
Turkey	201909267
Mexico	PA06002616	FORMULACION DE DISOLUCION RAPIDA DE COMPUESTO ACTIVO DE RECEPTOR DE CALCIO. (RAPID DISSOLUTION FORMULATION OF A CALCIUM RECEPTOR-ACTIVE COMPOUND.)
Turkey	201910177
New Zealand	297157	AMINE DERIVATIVES WITH CALCIUM ION RECEPTOR ACTIVITY; MEDICAMENTS CONTAINING SUCH COMPOUNDS
Australia	7197796

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	91182	Luxembourg		91182, EXPIRES: 20191022
1203761	CA 2005 00027	Denmark
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
1203761	05C0029	France		PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
1203761	300199	Netherlands

SENSIPAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sensipar (Cinacalcet)

Overview of Sensipar

Sensipar, also known as Cinacalcet, is a calcimimetic agent used primarily to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease on dialysis and hypercalcemia in patients with parathyroid carcinoma. It is a key product in Amgen's portfolio, having been approved by the US FDA in 2004.

Market Position and Competition

Dominance in the SHPT Market

Amgen Inc. has historically held a significant market share in the SHPT treatment market, largely due to its strong product portfolio, with Sensipar being a flagship drug. As of recent reports, Amgen holds around 40% of the market share in the U.S. SHPT treatment market[1].

Generic Competition

The market dynamics have shifted with the emergence of generic manufacturers following the patent expiration of Sensipar. Several companies, including Teva Pharmaceutical Industries Ltd., Abbvie, and Sandoz, have launched generic substitutes of Cinacalcet. This competition has driven the growth of the calcimimetics segment, with eight generic substitutes approved by the US FDA to date[1].

Financial Performance

Historical Revenue

Sensipar has been a high-revenue generator for Amgen. From its launch in 2004 to 2018, Sensipar's net U.S. revenue rose from $36 million to a peak of $1.4 billion. This significant revenue growth was fueled by consistent price increases and strong market demand[3].

Price Increases and Revenue Impact

Amgen has raised the price of Sensipar more than 20 times since its launch. For instance, the price of Sensipar increased from $2,956 per year in 2004 to $9,814 per year in recent times. These price increases have been a key factor in Amgen's profitability, despite the introduction of generic competition[3].

Impact of Generic Competition

The entry of generic competitors has led to a decline in Sensipar's sales. Amgen's quarterly sales for Sensipar have been affected by copycat competition, contributing to a 3% revenue decline for the company in certain quarters[5].

Market Growth Drivers

Increasing Patient Pool

The consistent rise in the burden of SHPT due to an increased patient pool for dialysis is a significant driver for the growth of the SHPT treatment market. Around 90% of patients with stage-5 chronic kidney disease (CKD) or end-stage renal disease (ESRD) suffer from SHPT, particularly in regions like the Midwest in the U.S.[1].

Improved Reimbursement Scenario

The improved reimbursement scenario in the U.S., with major treatment options covered under Part B Medicare, has augmented the growth of the SHPT treatment market, especially in the West and Northeast regions[1].

Online Channel Growth

The online channel segment for SHPT treatments is growing at a faster CAGR due to increased investment by key distributors in improving the e-pharmacy network in the U.S. This trend is expected to continue as more patients prefer home dialysis services[1].

Strategic and Competitive Tactics

Pricing Strategies

Amgen's pricing decisions for Sensipar have been driven by revenue targets. The company has engaged in "shadow pricing" with its competitor AbbVie, following similar price increase patterns to maintain market positioning[3].

Anticompetitive Tactics

Amgen has used various tactics to limit generic and biosimilar competition, including settlement agreements to delay the entry of generic equivalents and minor changes to the drug's design to extend market exclusivity[3].

Financial Trajectory

Recent Financial Performance

In recent years, Amgen's financial performance has been impacted by the decline in sales of Sensipar and other key products. Despite this, the company has reported strong overall financial results, with total revenues increasing by 23% to $8.5 billion in the third quarter of 2024, driven by volume growth and new product launches[2].

Future Outlook

Amgen expects total revenues for the full year 2024 to be in the range of $33.0 billion to $33.8 billion. The company is focusing on new product launches and pipeline advancements to offset the impact of generic competition on its older products like Sensipar[2].

Key Takeaways

• Market Dominance: Sensipar has been a leading drug in the SHPT treatment market, with Amgen holding a significant market share.
• Generic Competition: The entry of generic substitutes has impacted Sensipar's sales, but the overall market for SHPT treatments continues to grow.
• Pricing Strategies: Amgen's pricing decisions have been driven by revenue targets and competitive market dynamics.
• Financial Performance: Despite declines in Sensipar sales, Amgen's overall financial performance remains strong, driven by new product launches and a diverse portfolio.
• Future Outlook: The company is poised for continued growth through new product launches and strategic market positioning.

FAQs

What is Sensipar used for?

Sensipar, or Cinacalcet, is used to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease on dialysis and hypercalcemia in patients with parathyroid carcinoma.

How has the introduction of generic substitutes affected Sensipar's sales?

The introduction of generic substitutes has led to a decline in Sensipar's sales, as generic competition has eroded some of the market share held by Amgen's branded product.

What are the key drivers for the growth of the SHPT treatment market?

Key drivers include the increasing patient pool for dialysis, improved reimbursement scenarios, and the growth of online channels for drug distribution.

How has Amgen maintained its market position despite generic competition?

Amgen has used various strategies, including pricing decisions driven by revenue targets, settlement agreements to delay generic entry, and minor changes to the drug's design to extend market exclusivity.

What is Amgen's financial outlook for the future?

Amgen expects total revenues for the full year 2024 to be in the range of $33.0 billion to $33.8 billion, driven by new product launches and pipeline advancements.

Sources

1. US Secondary Hyperparathyroidism (SHPT) Treatment Market Size: Fortune Business Insights.
2. AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS: Stock Titan.
3. Drug Pricing Investigation: Oversight Democrats.
4. 2022 Letter to Shareholders: Amgen.
5. Amgen sales slide as copies dig into Sensipar, Neulasta: Fierce Pharma.