Etelcalcetide - Generic Drug Details

What are the generic sources for etelcalcetide and what is the scope of patent protection?

Etelcalcetide is the generic ingredient in one branded drug marketed by Kai Pharms Inc and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Etelcalcetide has one hundred and three patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for etelcalcetide

International Patents:	103
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	19
Patent Applications:	146
Drug Prices:	Drug price trends for etelcalcetide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for etelcalcetide
What excipients (inactive ingredients) are in etelcalcetide?	etelcalcetide excipients list
DailyMed Link:	etelcalcetide at DailyMed

See drug prices for etelcalcetide

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for etelcalcetide

Constraining patent/regulatory exclusivity:

10,344,765

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for etelcalcetide

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

Sponsor	Phase
Prim. Priv. Doz. Dr. Daniel Cejka	Phase 2
Amgen	Phase 2
Thomas Nickolas, MD MS	Phase 2

See all etelcalcetide clinical trials

Pharmacology for etelcalcetide

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

Anatomical Therapeutic Chemical (ATC) Classes for etelcalcetide

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 ETELCALCETIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PARSABIV	Injection	etelcalcetide	2.5 mg/0.5 mL 5 mg/mL 10 mg/2 mL	208325	2	2021-02-08

US Patents and Regulatory Information for etelcalcetide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-002	Feb 7, 2017		RX	Yes	Yes	10,344,765		Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-002	Feb 7, 2017		RX	Yes	Yes	11,162,500		Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes	10,344,765		Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-003	Feb 7, 2017		RX	Yes	Yes	11,162,500		Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-002	Feb 7, 2017		RX	Yes	Yes	9,278,995			Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-003	Feb 7, 2017		RX	Yes	Yes	9,701,712		Y	Y

EU/EMA Drug Approvals for etelcalcetide

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amgen Europe B.V.	Parsabiv	etelcalcetide	EMEA/H/C/003995 Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.	Authorised	no	no	no	2016-11-11

International Patents for etelcalcetide

Country	Patent Number	Title	Estimated Expiration
Norway	2017021
Cyprus	1121922
Eurasian Patent Organization	201690099	УСТОЙЧИВАЯ ЖИДКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ AMG-416 (ВЕЛКАЛЬЦЕТИД)
World Intellectual Property Organization (WIPO)	2011014707
Eurasian Patent Organization	030220	УСТОЙЧИВАЯ ЖИДКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ AMG-416 (ЭТЕЛКАЛЦЕТИД) (STABLE LIQUID FORMULATION OF AMG 416 (VELCALCETIDE))
South Africa	201200726	THERAPEUTIC AGENTS FOR REDUCING PARATHYROID HORMONE LEVELS

Supplementary Protection Certificates for etelcalcetide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2459208	PA2017007,C2459208	Lithuania		PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/16/1142 20161111
2459208	SPC/GB17/018	United Kingdom		PRODUCT NAME: ETELCALCETIDE, OR A SALT THEROF, INCLUDING ETELCALCETIDE HYDROCHLORIDE; REGISTERED: UK EU/1/16/1142/001-012 20161115; UK PLGB 13832/0039 20161115; UK PLGB 13832/0040 20161115; UK PLGB 13832/0041 20161115
2459208	C20170006 00208	Estonia		PRODUCT NAME: ETELKALTSETIID;REG NO/DATE: EU/1/16/1142 15.11.2016
2459208	17C1009	France		PRODUCT NAME: ETELCALCETIDE, OU UN SEL DE CELUI-CI, NOTAMMENT LE CHLORHYDRATE D'ETELCALCETIDE; REGISTRATION NO/DATE: EU/1/16/1142/001-012 20161115
2459208	CA 2017 00006	Denmark		PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115
2459208	PA2017007	Lithuania		PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/16/1142 20161111

Etelcalcetide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Etelcalcetide

Introduction

Etelcalcetide, a novel intravenous calcimimetic agent, has been making significant waves in the treatment of secondary hyperparathyroidism (SHPT) in patients undergoing hemodialysis. This article delves into the market dynamics and financial trajectory of etelcalcetide, highlighting its clinical efficacy, market adoption, and economic impact.

Clinical Efficacy of Etelcalcetide

Etelcalcetide has demonstrated robust clinical efficacy in reducing parathyroid hormone (PTH) levels in hemodialysis patients. Clinical trials have shown that etelcalcetide is non-inferior to cinacalcet, a widely used oral calcimimetic, and even superior in some secondary endpoints. For instance, etelcalcetide achieved a greater than 30% reduction in mean pre-dialysis serum intact PTH levels in a higher proportion of patients compared to cinacalcet[4].

Market Adoption

Since its introduction in April 2017, etelcalcetide has seen a steady increase in prescriptions. By August 2019, it accounted for 6% of prescriptions for hemodialysis patients in the US. The initial dosing was predominantly 15 mg/week in 70% of patients and 7.5 mg/week in 27% of patients. Notably, 49% of new users had previously been prescribed cinacalcet, indicating a transition to this new therapy[2].

Real-World Effectiveness

Real-world data from the US Dialysis Outcomes and Practice Patterns Study (DOPPS) showed that etelcalcetide led to significant and sustained reductions in PTH levels over 12 months. The mean PTH levels declined by 40%, and the proportion of patients with PTH within the target range increased from 33% to 64%[2].

Economic Evaluation

A decision-analytic model was developed to assess the cost-effectiveness of etelcalcetide compared to cinacalcet. The model included potential treatment effects on mortality, cardiovascular events, fractures, and treatment persistence. The results indicated that etelcalcetide had an incremental cost-effectiveness ratio (ICER) ranging from €1,355 to €47,687 per quality-adjusted life year (QALY), depending on the pricing assumptions. This suggests that etelcalcetide can be a cost-effective option under certain pricing scenarios[1].

Pricing and Cost Considerations

The economic evaluation of etelcalcetide considered various pricing options, assuming parity with cinacalcet and varying it by 15% or 30% increases. The cost-effectiveness analysis was robust across different sensitivity analyses, indicating that etelcalcetide could be a viable economic choice for healthcare systems[1].

Adverse Events and Safety Profile

While etelcalcetide has shown a favorable efficacy profile, it also comes with a side effect profile similar to other calcimimetics. Common treatment-emergent adverse events include decreased blood calcium, nausea, vomiting, and diarrhea. Symptomatic hypocalcemia was reported in 5% of patients receiving etelcalcetide, slightly higher than those receiving cinacalcet[4].

Market Competition

Etelcalcetide competes primarily with cinacalcet, an established oral calcimimetic. However, its intravenous administration and potential for better compliance and efficacy in certain patient populations position it as a strong competitor. The market for SHPT treatments is significant, given the prevalence of the condition among hemodialysis patients.

Financial Performance of Amgen

As the manufacturer of etelcalcetide, Amgen's financial performance is closely tied to the drug's market success. Amgen reported strong financial results in 2023, with total revenues increasing by 7% to $28.2 billion. While specific sales figures for etelcalcetide are not detailed in the latest reports, the overall growth in Amgen's General Medicine business segment, which includes etelcalcetide, indicates a positive trend[3].

Global Reach and Expansion

Amgen's global presence, with operations in roughly 100 countries, provides a broad platform for the distribution and marketing of etelcalcetide. The company's strategy to drive growth through volume increases rather than price hikes is particularly relevant in the context of intense global pressure on drug pricing[3].

Future Outlook

Given its clinical efficacy and cost-effectiveness, etelcalcetide is poised for continued growth. As more data becomes available from real-world studies and as healthcare systems increasingly adopt this therapy, its market share is likely to expand. Additionally, Amgen's ongoing investments in research and development will further solidify etelcalcetide's position in the market.

Key Takeaways

• Clinical Efficacy: Etelcalcetide has demonstrated non-inferiority to cinacalcet and superior efficacy in some endpoints.
• Market Adoption: Steady increase in prescriptions since its introduction in 2017.
• Economic Evaluation: Cost-effective under certain pricing scenarios.
• Safety Profile: Similar side effect profile to other calcimimetics with a slight increase in symptomatic hypocalcemia.
• Market Competition: Strong competitor to cinacalcet with potential for better compliance and efficacy.
• Financial Performance: Part of Amgen's growing General Medicine business segment.

FAQs

What is etelcalcetide used for?

Etelcalcetide is used for the treatment of secondary hyperparathyroidism (SHPT) in patients undergoing hemodialysis.

How is etelcalcetide administered?

Etelcalcetide is administered intravenously three times a week at the end of each dialysis session.

What are the common side effects of etelcalcetide?

Common side effects include decreased blood calcium, nausea, vomiting, and diarrhea. Symptomatic hypocalcemia is also reported in a small percentage of patients.

Is etelcalcetide cost-effective compared to cinacalcet?

Yes, etelcalcetide can be cost-effective under certain pricing scenarios, with an ICER ranging from €1,355 to €47,687 per QALY.

How has the market adoption of etelcalcetide been since its introduction?

Since its introduction in April 2017, etelcalcetide prescriptions have increased to 6% of hemodialysis patients in the US by August 2019.

Sources

1. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide Compared with Cinacalcet. PubMed.
2. Etelcalcetide Utilization, Dosing Titration, and Chronic Kidney Disease-Mineral and Bone Disorder Management in Hemodialysis Patients. PubMed.
3. Amgen 2023 Letter to Shareholders. Amgen Investors.
4. Amgen Presents Detailed Data Comparing Etelcalcetide With Cinacalcet in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis. Amgen Newsroom.
5. Bone Specific Alkaline Phosphatase and Serum Calcification Propensity in Hemodialysis Patients Treated With Etelcalcetide or Alfacalcidol. Frontiers in Medicine.