Carfilzomib - Generic Drug Details

What are the generic drug sources for carfilzomib and what is the scope of freedom to operate?

Carfilzomib is the generic ingredient in two branded drugs marketed by Apotex, Breckenridge, Dr Reddys, and Onyx Pharms Amgen, and is included in five NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carfilzomib has two hundred and twenty patent family members in forty-two countries.

There are ten drug master file entries for carfilzomib. One supplier is listed for this compound. There are six tentative approvals for this compound.

Summary for carfilzomib

International Patents:	220
US Patents:	4
Tradenames:	2
Applicants:	4
NDAs:	5
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	248
Patent Applications:	7,138
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carfilzomib
What excipients (inactive ingredients) are in carfilzomib?	carfilzomib excipients list
DailyMed Link:	carfilzomib at DailyMed

Recent Clinical Trials for carfilzomib

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

Sponsor	Phase
Assistance Publique - Hpitaux de Paris	PHASE2
Bristol-Myers Squibb	PHASE2
Regeneron Pharmaceuticals	PHASE3

See all carfilzomib clinical trials

Generic filers with tentative approvals for CARFILZOMIB

Applicant	Application No.	Strength	Dosage Form
		60MG/VIAL	POWDER;INTRAVENOUS
		10MG/VIAL	POWDER;INTRAVENOUS
		60MG	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for carfilzomib

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for carfilzomib

L01XG	Proteasome inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for CARFILZOMIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KYPROLIS	For Injection	carfilzomib	10 mg/vial	202714	1	2018-11-28
KYPROLIS	For Injection	carfilzomib	30 mg/vial	202714	1	2017-10-05
KYPROLIS	For Injection	carfilzomib	60 mg/vial	202714	9	2016-07-20

US Patents and Regulatory Information for carfilzomib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018		RX	Yes	Yes	7,737,112*PED				Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018		RX	Yes	Yes
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes	7,737,112*PED				Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	Yes
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	Yes	7,737,112*PED				Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes

Expired US Patents for carfilzomib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	8,207,126
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018	8,207,125
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018	8,207,127
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016	7,491,704
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	8,207,297
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018	7,232,818

EU/EMA Drug Approvals for carfilzomib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amgen Europe B.V.	Kyprolis	carfilzomib	EMEA/H/C/003790Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.	Authorised	no	no	yes	2015-11-19

International Patents for carfilzomib

Country	Patent Number	Title	Estimated Expiration
Austria	E494298
Austria	E496062
Australia	2005238445	Compounds for enzyme inhibition
Australia	2005271232	Compounds for proteasome enzyme inhibition
Australia	2005295183	Labeled compounds for proteasome inhibition
Australia	2012203602	Compounds for proteasome enzyme inhibition

Supplementary Protection Certificates for carfilzomib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781688	1690013-6	Sweden		PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/15/1060 20151123
1781688	CR 2016 00014	Denmark		PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/15/1060 20151123
1781688	362 5009-2016	Slovakia		PRODUCT NAME: KARFILZOMIB; NAT. REGISTRATION NO/DATE: EU1/15/1060 20151123; FIRST REGISTRATION: EU EU/1/15/1060 20151123
1781688	C 2016 014	Romania		PRODUCT NAME: CARFILZOMIB; NATIONAL AUTHORISATION NUMBER: EU/1/15/1060; DATE OF NATIONAL AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1060; DATE OF FIRST AUTHORISATION IN EEA: 20151119
1781688	132016000047656	Italy		PRODUCT NAME: CARFILZOMIB OPZIONALMENTE IN FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE(KYPROLIS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1060, 20151123
1781688	122016000032	Germany		PRODUCT NAME: CARFILZOMIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1060 20151119

Last updated: June 20, 2026

rfilzomib Market Dynamics and Financial Trajectory (2020–2024) Carfilzomib is a high-expense, branded proteasome inhibitor with long-running U.S. and ex-U.S. sales led by Amgen (Kyprolis). Demand is driven by relapsed/refractory multiple myeloma (RRMM) treatment positioning, regimen penetration with daratumumab and other backbones, and clinic reimbursement economics tied to infused oncology dosing. The near-to-medium-term financial trajectory depends on (1) schedule and regimen competitiveness versus bortezomib-based and other newer myeloma therapies, (2) payer and site-of-care pressures on infused, steroid-preemptive regimens, (3) biosimilar and generic risk to Kyprolis (and to any clinically substitutable carfilzomib presentations), and (4) expansion in combination lines of therapy.

How does carfilzomib (Kyprolis) perform financially and what drives revenue growth or decline?

Carfilzomib revenue is dominated by Kyprolis (single-agent and combination use in RRMM). Financial trajectory is shaped by a mix of unit growth (patient starts and treatment duration), net price (rebates, discounts, payer mix), and channel economics (hospital/infusion capacity and reimbursement).

Revenue drivers that typically move Kyprolis (carfilzomib) sales

1. Line-of-therapy penetration
   • Carfilzomib has durable positioning in RRMM, with sustained demand tied to ongoing need for next-line proteasome inhibition after prior regimens.
2. Combination regimen adoption
   • Myeloma treatment is moving toward combinations that include anti-CD38 antibodies, IMiDs, and proteasome inhibitors. Carfilzomib benefits when clinicians choose it as a backbone in combination regimens.
3. Dosing schedule and tolerability profile
   • Real-world uptake is sensitive to cardiovascular and renal tolerability, infusion time/logistics, and steroid/diuretic management practices. These factors affect treatment persistence and regimen switching.
4. Net price and payer controls
   • Oncology drug purchasing and contracting conditions typically pressure list price and increase rebate intensity. Net price trends usually determine margin stability even if gross demand holds.

Financial inflection points to watch in future quarters

• Regimen competition from other RRMM agents (including different proteasome inhibitor strategies, next-generation immunotherapies, and chemo-free combinations) can shift carfilzomib share.
• Access dynamics: site-of-care and payer utilization management can reduce patient starts or shorten duration in some subsegments.
• Safety management practice shifts can change persistence rates and impact protocol adherence.

What is the current U.S. and global market structure for carfilzomib, and how concentrated is it?

The global market is concentrated in a branded product ecosystem around Kyprolis. Supply-side concentration in carfilzomib is typically high because the active is delivered via a branded formulation and remains tied to an established IP estate and regulatory history for the reference drug.

Market structure characteristics

• Brand-led sales: The product is marketed by Amgen in most regions under the Kyprolis brand.
• Limited generic competition risk (historically): Generic versions depend on patent and exclusivity status plus an FDA pathway that can require bioequivalence, presentation compatibility, and labeling scope coverage.

Where demand clusters

• U.S. and Western Europe account for the bulk of sales due to high myeloma incidence, established oncology prescribing, and payer coverage for infusible specialty oncology drugs.
• Japan and select Asian markets have distinct access and pricing regimes that can support stable sales even when competitive pressure increases.

What is the Orange Book status of Kyprolis (carfilzomib) and which patents matter for generic entry?

Carfilzomib’s generic entry path depends on the active patents and any listed patents in the FDA Orange Book for Kyprolis. Patent lists commonly include composition/formulation, method-of-use, and manufacturing-related claims for the injectable presentations.

What to map in the Orange Book for a carfilzomib generic strategy

• Drug substance and composition of matter patents
• Formulation patents tied to concentration, stabilizers, buffers, and container closure
• Method-of-use patents covering specific combinations or treatment sequences
• Manufacturing process patents that can block authorization or require design-around

Litigation and exclusivity effects

• Any unexpired exclusivity or blocking patents can prevent FDA approval for generic or biosimilar alternatives, even if clinical equivalence is achievable.
• Paragraph IV filings (if any) can trigger automatic stays and settlement-driven launch delays in the U.S.

When does carfilzomib lose U.S. exclusivity, and what are the key expiration dates to model for revenue?

Revenue modeling for Kyprolis depends on:

• Patent expiration dates for listed Orange Book patents
• Any granted regulatory exclusivities (where applicable)
• Expected generic launch risk windows under the Hatch-Waxman framework

How to use expiration timelines in financial forecasting

• Build a scenario tree:
  1. Base case: no Paragraph IV entry until after the “last effective” patent date.
  2. Bull case: earlier market entry if key patents are invalidated or designed around.
  3. Bear case: delayed entry due to late settlements, injunctions, or additional patent thickets.

How do biosimilar risks apply to carfilzomib (Kyprolis)?

Carfilzomib is a small-molecule injectable, not a biologic. Biosimilar frameworks generally do not apply. Generic small-molecule equivalents and patent challenges are the relevant competitive mechanisms.

What formulations and presentations of carfilzomib drive switching and persistence?

Kyprolis is delivered as an infused injectable. Market behavior is tied to:

• Presentation-specific contracting (e.g., vial size, number of vials per dose, wastage)
• Administration time and premedication protocols
• Dose adjustments in renal impairment and patient frailty profiles

Key formulation features that influence adoption

• Stability and reconstitution characteristics
• Compatibility with infusion practices
• Container-closure and handling requirements that can affect real-world pharmacy operations

What patent estate strength does carfilzomib have, and how does it compare with other myeloma proteasome inhibitors?

Carfilzomib’s patent estate typically covers:

• composition/formulation,
• use in combination or in specific regimens,
• and manufacturing methods for the injectable product.

Comparative view versus bortezomib and other proteasome inhibitors

• Bortezomib: competition includes multiple formulations and long-running generics in some markets, which can compress pricing.
• Carfilzomib: historically maintained brand exclusivity longer in many jurisdictions due to a combination of formulation and method patents, plus entrenched infusion center workflows.
• Ixazomib (oral proteasome inhibitor): pricing and access dynamics differ due to oral administration and different safety considerations, which can shift patient and clinician preference.

What generic entry risks exist for Kyprolis, and what launch scenarios are most plausible?

Generic entry probability is driven by:

• Orange Book patent “last-to-expire” status,
• likelihood of Paragraph IV challenges,
• expected settlement terms (pay-for-delay style structures are possible historically in U.S. small-molecule contexts),
• and the feasibility of matching the injectable presentation without requiring costly changes that trigger new patent coverage.

Most common launch scenarios to model

• Narrow launch: entry for only specific strengths or with limited label scope.
• Full label launch: broader replacement across standard RRMM regimens if patents and exclusivity constraints are cleared.
• Delayed entry despite approvals: practical market access can lag when contracting and formulary placement take time.

What FDA regulatory status and labeling scope shape carfilzomib demand?

Kyprolis labeling and line-of-therapy positions determine addressable patient populations:

• RRMM indications,
• combinations with other standard therapies,
• and the treatment context that supports physician uptake.

How labeling affects commercial performance

• Label breadth can expand competition among regimens because clinicians can use the drug earlier in the disease course or in additional patient subgroups.
• Contraindication and precaution language can limit certain high-risk populations and reduce persistence.

How do payer reimbursement and site-of-care economics impact carfilzomib sales?

For infused oncology drugs, reimbursement risk is concentrated in:

• administration fees and infusion center economics,
• prior authorization and utilization management,
• and contracting that blends drug acquisition costs with facility billing.

Commercial outcomes tied to reimbursement

• Higher utilization with supportive coverage can raise patient starts.
• Tight prior authorization can slow new starts and shift treatment sequences.

What patent litigation affects carfilzomib (Kyprolis), and how do settlements influence launch timing?

U.S. patent litigation in Hatch-Waxman cases can shift launch dates by:

• triggering 30-month automatic stays,
• resulting in settlement-driven delayed launches,
• or producing court decisions that narrow or invalidate blocking claims.

How to translate litigation into revenue impact

• Revenue is most exposed in the quarter(s) when entry becomes imminent (e.g., post-stay clearance).
• Even without an entry, litigation outcomes can influence payer contracting decisions and formulary positioning.

Which companies are the competitive substitutes for carfilzomib in RRMM, and how do they affect price and volume?

Carfilzomib competes within a crowded RRMM therapeutic landscape that includes:

• anti-CD38 antibody regimens,
• other proteasome inhibitors (including oral and alternative dosing),
• IMiD-based strategies,
• and immune-oncology modalities depending on line-of-therapy.

Substitution patterns that reduce carfilzomib share

• Clinician preference shifts when adverse event profiles and convenience differ
• Payers may steer to lower net-cost regimens
• Newly adopted combination standards can change the “backbone” role of carfilzomib

Key financial trajectory: what should investors and licensors model next for carfilzomib?

A decision-grade forecast for Kyprolis should model revenue as:

• patient starts (access + label position),
• treatment duration (safety and persistence),
• net price (contracting and mix),
• and competitive erosion (generic entry risk plus regimen switching).

Revenue sensitivity map (directional)

• Increased regimen adoption and higher persistence raise revenue.
• Cardio-renal tolerability issues or stricter utilization management reduce duration and starts.
• Generic entry risk is the primary downside tail event.

Key Takeaways

• Carfilzomib (Kyprolis) revenue is mainly a function of RRMM regimen penetration, persistence tied to tolerability, and payer/site-of-care economics for infused administration.
• Patent and exclusivity status in the Orange Book governs generic entry risk and is the dominant driver of the downside tail scenario.
• Financial trajectory over the next few years should be modeled across patient starts, treatment duration, net price, and competitive substitution within RRMM combination standards.
• Biosimilar risk does not apply because carfilzomib is a small molecule; generic small-molecule entry and patent challenges are the relevant competitive mechanisms.

FAQs

1. What are the main Orange Book patent categories listed for Kyprolis (carfilzomib) that block generic substitution?
2. How do infusion administration logistics and premedication requirements affect real-world persistence for carfilzomib?
3. What RRMM combination regimens most influence carfilzomib volume and market share versus alternative proteasome inhibitor backbones?
4. What does a Paragraph IV challenge timeline typically imply for revenue timing before Kyprolis generic entry?
5. How do payer utilization management and site-of-care reimbursement policies most commonly impact oncology infused drugs like carfilzomib?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. FDA. Drug Approval Package: Kyprolis (carfilzomib). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/