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.

The generic ingredient in PARSABIV is etelcalcetide. There is one drug master file entry for this compound. 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 six 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

US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	4
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:

9,820,938

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 9,820,938.

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
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-002	Feb 7, 2017		RX	Yes	Yes	8,377,880		Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-003	Feb 7, 2017		RX	Yes	Yes	9,278,995			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/003995Parsabiv 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
Argentina	096773
Australia	2014302122
Brazil	112015032615
Canada	2916222
Chile	2015003738
China	105764487
China	114376970

Supplementary Protection Certificates for PARSABIV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2459208	PA2017007	Lithuania		PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/16/1142 20161111
2459208	300864	Netherlands		PRODUCT NAME: ETELCALCETIDE; REGISTRATION NO/DATE: EU/1/16/1142/001-012 20161115
2459208	122017000021	Germany		PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON, EINSCHLIESSLICH ETELCALCETIDHYDROCHLORID; AUTHORISATION NO/DATE: EU/1/16/1142 20161111
2459208	C20170006 00208	Estonia		PRODUCT NAME: ETELKALTSETIID;REG NO/DATE: EU/1/16/1142 15.11.2016
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	8/2017	Austria		PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON EINSCHLIESSLICH ETELCALCETID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1142 (MITTEILUNG) 20161115
2459208	LUC00008	Luxembourg		PRODUCT NAME: ETELCALCETIDE, OU UN SEL EQUIVALENT, Y COMPRIS LE CHLORHYDRATE D'ETELCALCETIDE (PARSABIV); AUTHORISATION NUMBER AND DATE: EU/1/16/1142 20161115

Last updated: July 26, 2026

PARSABIV (etelcalcetide) market dynamics and financial trajectory: pricing, growth, exclusivity, biosimilar/generic risk, and revenue outlook

PARSABIV (etelcalcetide) is a calcimimetic for secondary hyperparathyroidism (sHPT) in adults with chronic kidney disease on hemodialysis. The drug’s commercial trajectory is shaped by (1) uptake vs. competing calcimimetics in dialytic sHPT, (2) reimbursement and dosing economics tied to dialysis workflows, (3) patent and exclusivity timelines that limit generic or biosimilar substitution, and (4) market share shifts as payers tighten utilization management for expensive IV agents.

High-level financial read-through: PARSABIV’s revenue path has been supported by steady dialysis patient penetration and formulary wins in the US and select ex-US markets, while growth is constrained by penetration of the older oral calcimimetics (cinacalcet) and the established alternative IV calcimimetic (etelcalcetide’s category peer, if present in the same jurisdictions), along with payer pressure on per-unit spend. Material share and durability depend on label scope, local reimbursement, and ability to retain patients switching from cinacalcet.

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What drives PARSABIV market dynamics in hemodialysis secondary hyperparathyroidism?

Core demand engine

• Indication: secondary hyperparathyroidism in adults with CKD on hemodialysis.
• Patient base: tied to prevalence of ESRD/CKD on hemodialysis and the clinical management of parathyroid hormone (PTH) target ranges.
• Treatment continuity: patients stay on calcimimetics to maintain PTH control and mitigate downstream mineral bone disorder events.

Key commercial levers

1. Switching economics vs cinacalcet

   • PARSABIV is administered IV during dialysis, which can reduce pill burden and improve adherence relative to oral cinacalcet for some patient populations.
   • Payer and provider decisioning hinges on comparative cost per controlled PTH target, not only acquisition cost.

2. Dose-response and tolerability

   • Calcimimetic class toxicity (notably hypocalcemia risk) influences dose titration, monitoring intensity, and use of ancillary labs and interventions.
   • Commercial retention improves when sites see predictable titration and manageable safety workflows.

3. Payer coverage policy

   • Utilization management can be imposed through prior authorization, step therapy (often with cinacalcet), and preferred product lists.
   • Reimbursement dynamics are sensitive to incremental lab monitoring costs and claims adjudication patterns.

4. Site-of-care and workflow

   • IV administration during dialysis aligns prescribing with facility schedules, which can accelerate uptake when standardized treatment pathways exist.
   • Switching can be slowed if facilities require additional staff training, monitoring routines, or EMR order set updates.

Competitive context (category level)

• PARSABIV competes in calcimimetic management for sHPT, with oral cinacalcet as a dominant reference product in many markets.
• Differentiation is largely operational (IV dosing) and clinical positioning (control of PTH with dosing that can be titrated during dialysis).

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How is PARSABIV priced and reimbursed, and what does that mean for revenue?

Pricing architecture

• Revenue for IV specialty drugs is typically driven by net price after rebates, distribution channel mix, and payer contracting.
• Dialysis facility contracting can create variability in net revenue based on group purchasing dynamics and Medicare coverage assumptions (US) or tender processes (ex-US).

Reimbursement exposure points

• Claims adjudication tied to dialysis claims bundling can affect where value is recognized (drug budget vs facility budget).
• Hypocalcemia-related monitoring may indirectly influence payer willingness if it drives avoidable “cost-to-serve” burdens.

Featured-snippet answer

• PARSABIV revenue is most sensitive to net-to-gross contracting outcomes and payer policies that determine whether patients can switch from cinacalcet without a step/PA hurdle.

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What is the Orange Book status of PARSABIV and how does that affect launch or substitution risk?

US regulatory exclusivity structure PARSABIV is an FDA-approved small-molecule drug. US market exclusivity and patent coverage determine generic substitution ability.

Patent-exclusivity gating mechanisms

• Orange Book patent listings determine whether an ANDA can reference the NDA and include a Paragraph IV certification strategy.
• For older small molecules, exclusivity can include both:
  • NDA exclusivity (periods driven by first approval and changes qualifying under Hatch-Waxman)
  • Patent term (expiration by patent, including patent-specific filing dates and any applicable extensions)

Practical substitution implication

• If PARSABIV retains active Orange Book patents that cover composition, formulation, or method-of-use, generic entry is deterred or delayed.
• If only narrow method-of-use patents remain, generics can attempt design-around with carve-outs or different dosing instructions, subject to litigation risk.

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When does PARSABIV lose exclusivity and what expiration dates matter most?

What matters for market timing

• Market entry timing is driven by the first patent that blocks generic substitution (composition/formulation generally has the strongest barrier).
• “Soft” remaining patents (e.g., narrow methods) can still drive settlements but may allow delayed or risk-accepted entry.

How to model loss of exclusivity

• Build a “blocker list” of the earliest expiring Orange Book patents:
  • composition and salt/form of etelcalcetide
  • specific formulation or dilution stability
  • method-of-use for dosing schedules, PTH target titration, or dialysis administrations
• Then overlay any pediatric exclusivity and patent term adjustments/extensions.

Featured-snippet answer

• The first expiring patent that still prevents generic entry sets the practical timeline for Paragraph IV incentives and settlement leverage.

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What patent estate likely protects PARSABIV, and where are generic entry risks lowest?

Strongest likely patent categories (commercially)

• Drug substance/composition claims: typically block straightforward ANDA launches.
• Formulation claims: can block generic manufacturing and stability-equivalent products.
• Method-of-use claims tied to dialysis administration schedules and monitoring/titration frameworks: can block “safe harbor” labeling strategies.

Highest generic entry risks for competitors

• If patents cover the same dosing regimen (e.g., IV administration during dialysis with titration rules) and are embedded in label-relevant claims, ANDA filers face higher infringement exposure.
• If the patent estate is broad and includes multiple family members, the expected probability of a “free-and-clear” launch is lower.

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Which companies are challenging PARSABIV with Paragraph IV or biosimilar-style strategies?

US challenge mechanics

• For PARSABIV, generic challengers would pursue ANDA with Paragraph IV certifications against Orange Book listed patents.
• The commercial impact is driven by:
  • number of patents listed
  • depth of each patent’s coverage (composition vs method)
  • likelihood of settlement vs litigation outcome

Featured-snippet answer

• Paragraph IV challenges are the key predictor of generic entry timing for PARSABIV, with challenger identity and settlement terms determining when net price pressure begins.

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What PARSABIV litigation and settlements affect generic or biosimilar timelines?

Litigation effects

• Filed suits trigger automatic stay mechanics (within the framework of Hatch-Waxman) that can delay approval of an ANDA pending litigation outcomes.
• Settlement terms often define:
  • “as-if” launch dates (or first commercial sale dates)
  • stockpiling windows
  • permitted activities before agreed launch

Commercial implication

• The earlier the settlement date or the more favorable the exclusivity period to the innovator, the longer PARSABIV retains pricing power.
• A failed settlement increases the likelihood of a binary shift toward generic entry and revenue compression.

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How does PARSABIV compare with cinacalcet and other calcimimetics on market performance?

Comparison axes

• Route and workflow: IV during dialysis vs oral administration.
• Adherence and dosing titration practicality: facilities can apply IV dosing protocols.
• Safety monitoring: both are calcimimetics with hypocalcemia risk, but operational burden differs.

Commercial share dynamics

• Calcimimetic market share typically rotates based on:
  • formulary tier placement (preferred vs non-preferred)
  • prior authorization outcomes
  • patient switching patterns driven by provider experience
• PARSABIV’s growth tends to be strongest where payers and dialysis networks prefer IV workflow standardization.

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How many formulation and method-of-use patents protect PARSABIV, and why does it matter for generic entry?

Patent mapping categories (what to count) A generic entry risk model should count patents that are likely to be asserted:

• Composition of etelcalcetide (drug substance)
• Formulation (stability, buffer, concentration)
• Dilution/reconstitution or administration-related features
• Method-of-use (dose titration, dialysis session dosing, PTH target management)

Commercial impact of “count”

• More patents in composition/formulation increase litigation breadth and settlement complexity.
• Method-of-use patents can still drive settlements even if generic can technically manufacture.

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What manufacturing and IP barriers could delay PARSABIV or generic supply?

Supply risk

• For IV drugs used in dialysis, supply continuity depends on specialized sterile manufacturing, packaging, cold-chain or stability constraints (if any), and distributor allocation.
• Manufacturing constraints do not create legal exclusivity but can restrict substitution and delay competition.

IP barrier

• Even if legal exclusivity expires, manufacturing equivalence and label parity may be required for payers to allow switching.
• Patent-protected formulation or administration processes can slow ANDA approval and launch schedules.

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What is the FDA pathway and regulatory status for PARSABIV, and how does it affect uptake?

US approval and labeling impacts

• For sHPT in hemodialysis, FDA label language influences:
  • prescriber acceptance
  • payer prior authorization criteria
  • coding and coverage pathways for dialysis centers

Commercial effect

• Clear label instructions and predictable titration reduce friction in facility onboarding and reimbursement.

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What ex-US market dynamics matter for PARSABIV revenue growth?

Common cross-market constraints

• Tender systems or national reimbursement schedules determine net pricing and uptake speed.
• Local clinical guideline alignment with etelcalcetide dosing regimens can speed or slow switching.
• Biosimilar and generic calendars vary, and local patent enforcement affects effective exclusivity duration.

Revenue implication

• Ex-US growth tends to be more sensitive to reimbursement decision lags and tender outcomes than US uptake, where coverage policies can be adjusted more frequently through payer contracting cycles.

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PARSABIV financial trajectory: how to interpret revenue risk factors

Revenue positive drivers

• Continued dialysis patient treatment needs with stable long-term sHPT management.
• Treatment switching from oral calcimimetics where IV dosing is operationally preferred.
• Contracted net pricing stability through formulary wins.

Revenue negative drivers

• Payer step therapy and PA tightening.
• Increased competition through generic entry once exclusivity expires or through settlement-driven launch dates.
• Discount pressure tied to dialysis network procurement cycles.

Forecast framework used by investors and licensors

• Model revenue as:
  • addressable dialysis sHPT treated population
  • share of calcimimetic use captured by PARSABIV
  • net price trajectory (rebates, contracting changes)
  • durability of share (patient retention and conversion rate)

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Key timeline and scenario planning for PARSABIV (exclusivity-to-generic pressure)

Because the practical market turning points depend on Orange Book patent expirations and any Paragraph IV litigation/settlements, commercial scenario planning is typically structured as three phases:

1. Current active exclusivity phase

   • High pricing power, limited substitution
   • Revenue growth primarily driven by uptake and contracting strength

2. Pre-expiry phase

   • Visibility increases into challenger planning and payer preparation for substitution
   • Net price may face early pressure in anticipation of launch

3. Post-expiry or post-settlement launch window

   • Net price typically compresses sharply as generics capture share
   • Innovator response often includes contracting, patient support, and line extensions if available

A precision timeline requires the specific Orange Book blocker list and any litigation dockets. Without those patent-by-patent dates and case outcomes, only scenario structure can be stated.

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Key Takeaways

• PARSABIV market dynamics are driven by dialysis facility workflow adoption, payer coverage policy, and switching economics versus oral cinacalcet.
• The drug’s revenue trajectory depends on net pricing after rebates and contracting, plus durability of share in hemodialysis networks.
• Generic substitution risk is governed by Orange Book patent blockers and any Paragraph IV litigation/settlement outcomes.
• Commercial compression is most likely to occur around the first effective exclusivity loss date for composition/formulation or around settlement-defined launch dates.

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FAQs

1) What factors most influence PARSABIV share in US dialysis networks?
Formulary tier placement, prior authorization outcomes, ease of IV workflow integration during dialysis, and patient retention after PTH control and titration.

2) What kind of patents most deter generic ANDAs for PARSABIV?
Composition/drug substance and formulation patents typically create the hardest entry barriers, with method-of-use patents adding litigation leverage.

3) How do Paragraph IV challenges typically affect PARSABIV pricing before generic entry?
They increase payer and provider preparation for substitution, which can start net price pressure ahead of the actual launch.

4) Does IV administration during dialysis change payer reimbursement dynamics for PARSABIV?
Yes, reimbursement outcomes depend on how drug spend is handled in dialysis billing and facility budgets, plus monitoring and coding practices tied to label usage.

5) What ex-US variables can delay PARSABIV uptake even if it is approved?
Tender terms, national reimbursement timelines, local guideline alignment, and patent enforcement that defines effective exclusivity.

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (PARSABIV/etelcalcetide). FDA.
2. FDA. PARSABIV (etelcalcetide) prescribing information. US Food and Drug Administration.

(Citations are limited to the FDA Orange Book and label as the governing sources for exclusivity status and labeling-driven commercialization.)

DrugChatter Q&A for PARSABIV

Parsabiv etelcalcetide?
Routes of administration parsabiv?