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PARSABIV Drug Patent Profile

Which patents cover Parsabiv, and what generic alternatives are available?

Parsabiv is a drug marketed by Kai Pharms Inc and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in PARSABIV is etelcalcetide. One supplier is listed for this compound. Additional details are available on the etelcalcetide profile page.

DrugPatentWatch^® Generic Entry Outlook for Parsabiv

Parsabiv was eligible for patent challenges on February 7, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 27, 2034. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for PARSABIV

International Patents:	103
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	4
Patent Applications:	39
Drug Prices:	Drug price information for PARSABIV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PARSABIV
What excipients (inactive ingredients) are in PARSABIV?	PARSABIV excipients list
DailyMed Link:	PARSABIV at DailyMed

See drug prices for PARSABIV

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

Constraining patent/regulatory exclusivity:

10,344,765

NDA:

208325

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 PARSABIV

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

Sponsor	Phase
Prim. Priv. Doz. Dr. Daniel Cejka	Phase 2
Amgen	Phase 2
Amgen	Phase 3

See all PARSABIV clinical trials

Pharmacology for PARSABIV

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

Paragraph IV (Patent) Challenges for PARSABIV

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 PARSABIV

PARSABIV is protected by eight US patents.

This potential generic entry date is based on patent 10,344,765.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	208325-001	Feb 7, 2017		RX	Yes	Yes	8,999,932		Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-003	Feb 7, 2017		RX	Yes	Yes	9,701,712		Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-003	Feb 7, 2017		RX	Yes	Yes	8,377,880		Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes	9,820,938		Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes	10,344,765		Y

EU/EMA Drug Approvals for PARSABIV

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 PARSABIV

When does loss-of-exclusivity occur for PARSABIV?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PARSABIV around the world.

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))

Supplementary Protection Certificates for PARSABIV

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

PARSABIV Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Parsabiv (Etelcalcetide)

Introduction

Parsabiv, also known as etelcalcetide, is a calcimimetic agent developed by Amgen for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Here, we delve into the market dynamics and financial trajectory of this drug.

FDA Approval and Initial Challenges

Parsabiv was initially rejected by the U.S. Food and Drug Administration (FDA) in August 2016, but it was later approved on February 8, 2017. The FDA rejection was based on a Complete Response Letter (CRL), the details of which Amgen did not disclose, sparking criticism from analysts like Adam Feuerstein for the lack of transparency[1][3].

Mechanism and Clinical Significance

Parsabiv works by mimicking the action of calcium by activating calcium-sensing receptors on the parathyroid gland, leading to decreased parathyroid hormone (PTH) levels. This mechanism is crucial for managing sHPT, a condition that affects approximately 88% of patients on dialysis and 79% of hemodialysis patients[1].

Market Size and Growth

The U.S. secondary hyperparathyroidism (SHPT) treatment market, where Parsabiv operates, was valued at USD 4.34 billion in 2018 and is projected to reach USD 9.88 billion by 2032. This growth is driven by the increasing demand for effective SHPT treatments and the approval of generic substitutes for existing therapies like Cinacalcet[4].

Competitive Landscape

Amgen dominates the SHPT treatment market with around 40% market share, primarily due to its strong product portfolio, including Sensipar (Cinacalcet) and Parsabiv. However, the market is becoming more competitive with the emergence of generic manufacturers such as Teva Pharmaceutical Industries Ltd., Abbvie, and Sandoz[4].

Financial Performance of Parsabiv

While specific financial figures for Parsabiv are not always detailed separately, Amgen's overall financial performance provides insights into the drug's impact. In the third quarter of 2024, Amgen reported total revenues of $8.5 billion, with product sales growing 24% and a notable contribution from rare disease products, which includes Parsabiv[2].

Revenue Contribution

Parsabiv, along with other calcimimetic agents, contributes to the growth of Amgen's revenue. Although it is not a "make-or-break" product for Amgen, its approval and market presence have been significant. For instance, the approval of Parsabiv marked the first new treatment for sHPT in over a decade, which has helped in expanding Amgen's market share in this segment[1][3].

Operating Expenses and Margins

Amgen's financial reports indicate that while the company has seen an increase in operating expenses, partly due to the inclusion of the Horizon business, the overall financial health remains robust. The GAAP operating margin decreased to 25.1%, but non-GAAP operating margin remained at 49.6% in the third quarter of 2024. These figures suggest that despite increased expenses, Amgen's product portfolio, including Parsabiv, continues to drive revenue growth[2].

Product Sales and Market Share

Parsabiv's sales performance is part of Amgen's broader product sales growth. The drug has been one of the contributors to the company's increased revenue, especially in the rare disease segment. Amgen's dominance in the SHPT market, coupled with the emergence of generic competitors, indicates a dynamic market where Parsabiv plays a significant role[4].

Future Outlook

For the full year 2024, Amgen expects total revenues in the range of $33.0 billion to $33.8 billion. The company's guidance includes expectations for continued growth driven by its product portfolio, including Parsabiv. The increasing demand for SHPT treatments and the establishment of guidelines for improving treatment are expected to further boost the market growth of Parsabiv and similar drugs[2].

Key Takeaways

• FDA Approval: Parsabiv was approved by the FDA in February 2017 after an initial rejection.
• Market Growth: The U.S. SHPT treatment market is projected to grow significantly, driven by increasing demand and generic approvals.
• Competitive Landscape: Amgen dominates the market, but faces increasing competition from generic manufacturers.
• Financial Performance: Parsabiv contributes to Amgen's revenue growth, although specific figures are not always detailed.
• Future Outlook: Amgen expects continued revenue growth driven by its product portfolio, including Parsabiv.

FAQs

What is Parsabiv used for?

Parsabiv (etelcalcetide) is used for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

Why was Parsabiv initially rejected by the FDA?

Parsabiv was initially rejected by the FDA in August 2016 based on a Complete Response Letter (CRL), but the specific reasons were not disclosed by Amgen.

How does Parsabiv work?

Parsabiv works by mimicking the action of calcium by activating calcium-sensing receptors on the parathyroid gland, leading to decreased parathyroid hormone (PTH) levels.

What is the market size of the U.S. SHPT treatment market?

The U.S. SHPT treatment market was valued at USD 4.34 billion in 2018 and is projected to reach USD 9.88 billion by 2032.

Who are the key players in the SHPT treatment market?

Amgen dominates the market with around 40% market share, followed by generic manufacturers such as Teva Pharmaceutical Industries Ltd., Abbvie, and Sandoz.

What are Amgen's financial expectations for 2024?

Amgen expects total revenues in the range of $33.0 billion to $33.8 billion for the full year 2024, with continued growth driven by its product portfolio.

Sources

1. BioSpace: Amgen Remains Hush-Hush Over FDA Rejection of Parsabiv
2. StockTitan: AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS
3. BioSpace: FDA Approves Amgen's Parsabiv (Etelcalcetide), First New Treatment in More Than a Decade for Secondary Hyperparathyroidism in Adult Patients on Hemodialysis
4. Fortune Business Insights: US Secondary Hyperparathyroidism (SHPT) Treatment Market Size, Share & COVID-19 Impact Analysis, By Drug Class (Calcimimetics, Vitamin D Analogues, and Phosphate Binders), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and Regional Forecast, 2023-2032