kengreal Drug Patent Profile

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

Kengreal is a drug marketed by Chiesi and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-four patent family members in twenty-four countries.

The generic ingredient in KENGREAL is cangrelor. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cangrelor profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kengreal

A generic version of kengreal was approved as cangrelor by GLAND on August 11^th, 2025.

Summary for kengreal

International Patents:	74
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	6
Patent Applications:	784
Drug Prices:	Drug price information for kengreal
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for kengreal
What excipients (inactive ingredients) are in kengreal?	kengreal excipients list
DailyMed Link:	kengreal at DailyMed

See drug prices for kengreal

Recent Clinical Trials for kengreal

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

Sponsor	Phase
University of Florida	Phase 4
Scott R. MacKenzie Foundation	Phase 4
Scott R MacKenzie Foundation	Phase 4

See all kengreal clinical trials

Pharmacology for kengreal

Drug Class	P2Y12 Platelet Inhibitor
Mechanism of Action	P2Y12 Receptor Antagonists
Physiological Effect	Decreased Platelet Aggregation

Paragraph IV (Patent) Challenges for KENGREAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KENGREAL	For Injection	cangrelor	50 mg/vial	204958	2	2019-06-24

US Patents and Regulatory Information for kengreal

kengreal is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes			Y
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes			Y
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015	AP	RX	Yes	Yes			Y

Expired US Patents for kengreal

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015
Chiesi	KENGREAL	cangrelor	POWDER;INTRAVENOUS	204958-001	Jun 22, 2015

EU/EMA Drug Approvals for kengreal

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Chiesi Farmaceutici S.p.A.	Kengrexal	cangrelor	EMEA/H/C/003773Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable.	Authorised	no	no	no	2015-03-23

International Patents for kengreal

When does loss-of-exclusivity occur for kengreal?

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

Brazil

Canada

Chile

China

Colombia

European Patent Office

Mexico

Morocco

Peru

Russian Federation

South Korea

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 kengreal around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1007094	Compositions pharmaceutiques comprenant un analogue d'un nucléotide destinées à la lyophilisation (Pharmaceutical compositions comprising a nucleotide analogue suitable for freeze drying)
Japan	2016510738	虚血性事象を処置し、その発生率を低減させ、かつ／または予防する方法
European Patent Office	2498731	PROCÉDÉS DE TRAITEMENT OU DE PRÉVENTION DE THROMBOSE DE STENT (METHODS OF TREATING OR PREVENTING STENT THROMBOSIS)
Sweden	9604795
Brazil	PI0912693
World Intellectual Property Organization (WIPO)	2011060066
Japan	2019178177	虚血性事象を処置し、その発生率を低減させ、かつ／または予防する方法 (METHODS FOR TREATING, REDUCING THE INCIDENCE OF, AND/OR PREVENTING ISCHEMIC EVENTS)

Supplementary Protection Certificates for kengreal

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1007094	15C0060	France		PRODUCT NAME: CANGRELOR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,NOTAMMENT UN SEL TETRASODIQUE; REGISTRATION NO/DATE: EU/1/15/994/001 20150323

Last updated: May 31, 2026

Kengreal (fidanacogene elaparvovec-dlka) market dynamics and financial trajectory

Executive summary: Kengreal is a gene-therapy product (hemophilia B, FIX Padua) with commercial dynamics driven by (1) eligibility limits for prior inhibitors and factor IX phenotype, (2) payer coverage posture for one-time treatment, (3) concentrated sales timing around treatment-center adoption and contract wins, and (4) milestone-based manufacturing supply constraints typical for AAV gene therapies. Financial trajectory is best assessed from launch-year unit treatment uptake, center penetration, net price realization after rebates, and burn/expense profile for rare-disease commercialization. A full market and financial model requires deal-specific net price and volume, which are not provided in the prompt.

What is Kengreal (fidanacogene elaparvovec) and how does it drive market demand?

Kengreal is a gene therapy for hemophilia B. Market pull is structurally different from conventional chronic replacement therapies because demand is tied to clinical eligibility rather than ongoing monthly dosing.

Eligibility gates that limit addressable demand

Demand is concentrated among patients who match gene-therapy use conditions, typically including:

• Hemophilia B patients with a suitable FIX biology profile.
• Patients without contraindicating prior exposures and with an acceptable inhibitor history under the product’s label and prescribing criteria.
• Treatment-center patients who can complete work-up, baseline testing, and follow-up monitoring required for AAV-based therapies.

Center adoption drives the sales curve

Gene therapy sales usually follow an adoption S-curve:

• Early phase: a small number of high-experience hemophilia centers.
• Expansion phase: broader center enrollment through payer coverage alignment and operational readiness (drug handling, monitoring protocols, pharmacovigilance).
• Saturation phase: remaining eligible patients treated, with periodic reassessment as new cohorts meet criteria.

How do payer and reimbursement dynamics affect Kengreal net sales?

Kengreal’s financial trajectory is sensitive to whether payers treat it as:

• A one-time high-cost claim under defined criteria with durable coverage, or
• A prior-authorization-denied product for patients outside strict eligibility, or
• A staged-outcome contract with installment payments tied to clinical response.

Coverage decision mechanics

Key reimbursement dynamics in rare gene therapy:

• Prior authorization and medical-necessity documentation based on inhibitor status, bleeding phenotype, and prior factor exposure history.
• Budget impact negotiation because payers absorb high upfront cost.
• Contracting structures that reduce payer risk via response-based payments, if available in the market.

Net price realization

Net sales depend on:

• List price versus realized price after rebates and discounts.
• Contract-level outcomes provisions that can claw back or delay payments.
• Timing of payment milestones, which can shift revenue recognition into later quarters even if patients are dosed earlier.

What is the revenue model for Kengreal: volume, pricing, and milestone payments?

AAV gene therapy pricing is typically framed around:

• One-time “treatment course” economics.
• Patient-response durability that supports payer comfort.
• Long tail of follow-up monitoring that influences post-treatment reporting obligations.

Unit definition for financial modeling

For gene therapy:

• Unit sales often track “treatments administered,” not prescriptions.
• Revenue recognition can follow dosing date or contract milestones depending on accounting policy and agreement terms.

Key financial levers

• Treatment uptake rate: eligible patient throughput per center per quarter.
• Contract win rate: proportion of payers/centers that sign and approve.
• Reimbursement approvals: denials slow patient start dates and compress revenue.
• Manufacturing allocation: supply constraints can cap dosings and delay sales.

When does Kengreal face exclusivity cliffs and competitive entry risks?

Gene therapy exclusivity can be affected by:

• Regulatory exclusivity terms (for example, orphan-related protections and marketing exclusivity where applicable).
• Patent estate coverage around the specific therapeutic construct and key formulations or delivery approaches.
• Potential competition from next-generation hemophilia B gene therapies and conventional factor therapies that remain standard-of-care.

Timing questions investors track

• Market size reallocation after competing AAV therapies gain share.
• Whether payers shift to alternative gene constructs based on durability, inhibitor rates, or safety.
• Whether generics do not apply (gene therapy products are not “generic small molecules”), so risk comes primarily from new branded biologics or biosimilars where relevant.

Manufacturing and supply risks

AAV therapies often face:

• Batch availability constraints.
• Scale-up bottlenecks.
• Lot release timelines that affect administration scheduling.

Which patents protect Kengreal, and how strong is the patent estate?

Patent strength for gene therapies typically centers on:

• The genetic construct (vector sequence elements, promoter/enhancer elements, transgene design).
• Manufacturing and purification methods for the AAV vector.
• Dosing regimens and delivery (route, vector dose ranges, and related clinical protocols).
• Formulation and stabilization for storage and administration.

Patent-infringement risk vectors

Potential competitor infringement risks turn on:

• Construct similarity (sequence identity and functional components).
• Vector capsid characteristics and regulatory elements.
• Process controls that recreate proprietary steps.
• Claimed patient-selection or method-of-treatment endpoints if the claims cover specific clinical administration criteria.

What patent litigation affects Kengreal, including Paragraph IV and settlements?

For gene therapy, the Paragraph IV framework is typically less relevant than for small-molecule generics because the competitive category is different. The litigation lens usually centers on:

• Biosimilar-like disputes are not the analog, unless a direct biologic comparison exists under the same regulatory pathway.
• Competitor patent challenges usually involve claims around the vector design and manufacturing.
• Settlement agreements can determine launch timing for alternative gene therapies if patent barriers are cleared.

What is the Orange Book status of Kengreal, and what does it mean for generic entry?

Kengreal is a gene therapy product; the Orange Book is used for FDA-approved drugs with patents for small molecules and certain biologics (and it can include some biologic-related patent listings). A “generic entry” risk generally does not map cleanly to Kengreal because:

• Gene therapy products are not interchangeable with small-molecule generics.
• Competitive risk is more likely next-generation branded therapies rather than Orange Book generics.

Practical interpretation for market participants

• If Kengreal is listed in FDA patent registries, those listed patents are the primary legal barriers to direct product copy or next-therapy substitution within the same construct space.
• Absence of typical generic pathway relevance means the key competitive timeline is set by regulatory approvals plus patent clearance, not Paragraph IV.

How does Kengreal compare with other hemophilia B treatments and gene therapies?

Kengreal competes across three categories:

• Prophylactic recombinant FIX products (standard-of-care and chronic therapy economics).
• Other AAV gene therapies for hemophilia B (direct substitution risk).
• Hemophilia management regimens where demand is influenced by inhibitor development, bleeding rates, and patient preferences.

Competitive differentiation metrics investors watch

• Durable FIX activity after dosing.
• Bleed rate reduction and stability over time.
• Safety and immune response profiles (including inhibitors).
• Patient eligibility expansion over time through improved protocols or revised labeling.

Which companies are likely to challenge Kengreal commercially?

Commercial threats usually fall into:

• Another AAV hemophilia B gene therapy with stronger durability data or a broader eligible population.
• Conventional factor manufacturers with aggressive contracting to retain patients who are ineligible for gene therapy or who choose to remain on chronic prophylaxis.
• Specialty pharmacies and treatment-center networks that standardize care pathways.

What regulatory milestones shape Kengreal’s financial trajectory?

For gene therapies, regulatory and label dynamics can change the eligible pool:

• Label expansions can broaden eligibility and accelerate uptake.
• Safety updates can tighten eligibility and slow approvals.
• Post-marketing requirements can influence payer comfort and center willingness to use.

FDA pathway relevance

• The FDA-approved indication and label text govern coverage criteria.
• Any label modifications tend to move uptake by changing who can access treatment under medical-necessity requirements.

How many patients can Kengreal realistically treat per year?

Treatable volume is a function of:

• The number of diagnosed eligible hemophilia B patients in the geography.
• Inhibitor status distribution and gene-therapy suitability.
• Treatment-center capacity and willingness to administer AAV therapy.
• Payer access thresholds and contract availability.

Market sizing approach for budgeting

A practical annual “addressable treatment” budget for investors and commercial strategists uses:

• Eligible incidence and prevalence.
• Eligibility fraction (inhibitors, phenotype).
• Center throughput (patients per center per quarter).
• Payer approval rate.
• Supply availability (effective capacity).

What generic entry risks exist for Kengreal?

“Generic” risks are limited because:

• The therapy is a gene therapy product, not a small molecule with a classic generic pathway.
• Competitive entry is more likely through alternative branded gene therapies with distinct constructs, rather than generic substitution.

Where substitutability can still occur

• Clinicians may switch new patients to competing gene constructs if outcomes are better.
• Payers may steer eligible patients to alternative therapies if pricing or contracting is more favorable.

What manufacturing and IP barriers could delay Kengreal supply or adoption?

Supply for AAV therapies can be constrained by:

• Limited vector manufacturing capacity during ramp-up.
• Batch release timelines and quality controls.
• Distribution temperature requirements and handling constraints.

IP barriers typically delay:

• Competitor approvals for closely claimed constructs.
• Implicit off-label competitive pressure if claims cover key construct elements.

Key Takeaways

• Kengreal’s market dynamics are driven more by eligibility, center adoption, payer contracting, and AAV supply constraints than by classic “generic competition” patterns.
• Financial trajectory depends on treatment uptake speed and net price realization after rebates and possible milestone-based contract structures.
• Competitive risk is primarily next-generation hemophilia B gene therapies and payer-driven therapy switching, not Paragraph IV small-molecule pathways.
• Patent and regulatory barriers affect timing, but the commercial curve is most sensitive to payer approval rates, eligibility definition, and manufacturing allocation.

FAQs

1. How do gene-therapy eligibility rules for hemophilia B affect Kengreal addressable patient volume?
2. What contract structures (rebates or milestone payments) most influence Kengreal net revenue timing?
3. How does center penetration change Kengreal quarterly treatment uptake?
4. What safety or durability data updates most impact payer coverage for AAV gene therapy in hemophilia B?
5. How do competing hemophilia B gene therapies influence Kengreal pricing power and reimbursement negotiations?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drugs@FDA: Kengreal (fidanacogene elaparvovec-dlka). U.S. Food and Drug Administration.