CANGRELOR Drug Patent Profile

Which patents cover Cangrelor, and when can generic versions of Cangrelor launch?

Cangrelor is a drug marketed by Gland and MSN and is included in two NDAs.

The generic ingredient in CANGRELOR is cangrelor. There is one drug master file entry 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 Cangrelor

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

Summary for CANGRELOR

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	32
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CANGRELOR
DailyMed Link:	CANGRELOR at DailyMed

Recent Clinical Trials for CANGRELOR

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

Sponsor	Phase
University of Florida	PHASE4
IRCCS San Raffaele	PHASE2
Federico II University	Phase 4

See all CANGRELOR clinical trials

Pharmacology for CANGRELOR

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

Anatomical Therapeutic Chemical (ATC) Classes for CANGRELOR

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for CANGRELOR

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 CANGRELOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gland	CANGRELOR	cangrelor	POWDER;INTRAVENOUS	213551-001	Aug 11, 2025	AP	RX	No	No
Msn	CANGRELOR	cangrelor	POWDER;INTRAVENOUS	213703-001	Jun 4, 2026	AP	RX	No	No

EU/EMA Drug Approvals for CANGRELOR

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

Cangrelor Market Dynamics, Financial Trajectory, Patents, and Generic Entry Risk

Last updated: September 3, 2026

Cangrelor, marketed as Kengreal by Chiesi USA, is a short-acting intravenous P2Y12 platelet inhibitor used during percutaneous coronary intervention (PCI). Its commercial value comes from a narrow but clinically important role: immediate platelet inhibition when oral therapy is impractical, absorption is unreliable, or rapid reversal is required. The product has no biosimilar risk because cangrelor is a chemically synthesized small molecule. Its principal long-term threat is generic intravenous competition, although limited procedural use, hospital formulary controls, and manufacturing complexity constrain the opportunity.

Standalone Kengreal revenue is not routinely disclosed by Chiesi, which is privately held. Historical disclosures from The Medicines Company showed a product moving from launch-stage adoption toward a commercially established hospital franchise before Chiesi acquired U.S. rights. The product’s financial trajectory therefore depends more on procedure volume, hospital conversion, price realization, and generic timing than on broad outpatient prescription growth.

What is cangrelor and how does Kengreal work?

Cangrelor is an intravenous, reversible P2Y12 receptor antagonist. Kengreal is supplied as a lyophilized powder for intravenous infusion and is administered during PCI in adults who have not received a P2Y12 inhibitor before the procedure or who cannot receive oral therapy.

Its pharmacologic profile creates the commercial niche:

Attribute	Cangrelor profile
Drug class	Intravenous P2Y12 platelet inhibitor
Brand	Kengreal
Active ingredient	Cangrelor
FDA approval	June 22, 2015
Administration	Intravenous bolus followed by infusion
Onset	Immediate platelet inhibition
Offset	Platelet function returns toward baseline within about one hour after discontinuation
Primary setting	PCI, including urgent or emergent procedures
Regulatory category	New drug application, NDA 207476
Main competitors	Clopidogrel, prasugrel, ticagrelor, crushed oral P2Y12 regimens
Biosimilar exposure	None
Principal patent risk	Generic small-molecule competition

The label positions cangrelor for patients undergoing PCI who have not been treated with another P2Y12 platelet inhibitor and who are not being treated with an intravenous glycoprotein IIb/IIIa inhibitor. It is not a chronic maintenance product. This limits prescription volume but supports use in high-acuity procedural settings (U.S. Food and Drug Administration [FDA], 2024a).

What clinical and commercial need does cangrelor address?

Cangrelor addresses the gap between the need for immediate platelet inhibition and the limitations of oral P2Y12 agents.

Oral clopidogrel, prasugrel, and ticagrelor can be difficult to use when a patient is intubated, vomiting, hemodynamically unstable, unconscious, or unable to absorb enteral medication. Their effects also persist after administration, which complicates urgent surgery. Cangrelor can be stopped shortly before surgery or another invasive intervention.

Its strongest commercial use cases are:

• Emergent or urgent PCI before oral antiplatelet therapy can take effect.
• Patients unable to swallow or absorb oral medication.
• Patients requiring temporary platelet inhibition while oral therapy is interrupted.
• Cath-lab protocols that prioritize predictable onset and offset.
• Selected high-risk coronary interventions where delayed P2Y12 activity is considered unacceptable.

The product competes against clinical workarounds as much as against branded drugs. These include crushed ticagrelor, nasogastric administration, delayed oral loading, and use of intravenous glycoprotein IIb/IIIa inhibitors. Those alternatives limit the addressable market.

How large is the cangrelor market?

The addressable market is the number of PCI procedures in which immediate, reversible intravenous P2Y12 inhibition offers a meaningful advantage. It is materially smaller than the total PCI market.

Global PCI volume is measured in the millions of procedures annually, but most patients receive an oral P2Y12 inhibitor. Cangrelor penetration is concentrated in a minority of cases. Key adoption constraints include:

1. Many PCI patients can receive oral ticagrelor, clopidogrel, or prasugrel.
2. Hospitals often restrict cangrelor to emergency, high-risk, or protocol-defined cases.
3. The drug requires infusion equipment and pharmacy or cath-lab preparation.
4. Guideline language generally supports selective rather than routine use.
5. Cost per procedure is higher than generic oral alternatives.

The market therefore behaves like a hospital specialty product rather than a mass-market cardiovascular drug. Volume is tied to PCI throughput, emergency-case mix, hospital protocols, and physician preference.

Which products compete with cangrelor?

Product	Route	Commercial position relative to cangrelor
Clopidogrel	Oral	Low-cost generic standard; slower and less predictable onset
Prasugrel	Oral	Potent PCI option; unsuitable for some patients and not reversible quickly
Ticagrelor	Oral	Rapid oral option; broad use but persistent effect and absorption limitations
Glycoprotein IIb/IIIa inhibitors	Intravenous	Rescue or high-risk procedural alternatives; different mechanism and bleeding profile
Crushed oral P2Y12 agents	Oral or enteral	Workaround when rapid oral exposure is needed
Cangrelor	Intravenous	Immediate, reversible P2Y12 inhibition for selected procedural patients

The largest competitive threat is not a single replacement product. It is the combination of generic oral therapy, hospital protocols, and improved enteral administration.

What is the financial trajectory for Kengreal?

Kengreal’s public financial history indicates commercial growth after approval, followed by a transition from The Medicines Company to Chiesi. The Medicines Company reported Kengreal net sales in its annual filings, but Chiesi has not provided a comparable recurring public revenue series.

The financial trajectory can be divided into four phases:

Period	Commercial phase	Financial implication
2015-2016	FDA launch and early hospital adoption	Low initial revenue; formulary and physician education required
2017-2019	Expansion in PCI protocols and emergency use	Increasing sales and improved hospital penetration
2020 onward	Chiesi ownership of U.S. rights	Revenue integrated into Chiesi’s specialty-care portfolio
Post-exclusivity period	Generic and contracting pressure	Greater risk to price, hospital share, and gross margin

The Medicines Company’s annual reports recorded Kengreal revenue growth during the years before the company’s acquisition by Novartis. Public filings identified Kengreal as one of the company’s commercial products, but reported figures should not be treated as a current Chiesi revenue forecast because ownership, reporting periods, and portfolio composition changed.

Chiesi’s private-company structure reduces financial transparency. It does not publish a public-company-level product revenue statement for Kengreal comparable with the historical Securities and Exchange Commission filings of The Medicines Company. The most defensible commercial indicators are therefore:

• Continued FDA-listed marketing status.
• Ongoing inclusion in hospital procurement channels.
• Chiesi’s continued cardiovascular and specialty-care commercial infrastructure.
• Stable clinical demand in PCI settings.
• Exposure to generic pricing once relevant regulatory and patent barriers fall.

When does cangrelor lose exclusivity?

Cangrelor’s five-year new chemical entity exclusivity from the June 22, 2015 approval date would have expired in 2020, subject to the specific FDA regulatory record and any applicable exclusivity adjustments. Regulatory exclusivity does not equal patent protection. Generic or 505(b)(2) entry remains dependent on Orange Book patents, certifications, litigation, and FDA approval requirements.

The key dates are:

Event	Date or status
FDA approval of Kengreal	June 22, 2015
Five-year NCE exclusivity	Expired in 2020, based on the approval date
Pediatric exclusivity	No separate extension is identified in the principal FDA approval materials reviewed
Current regulatory protection	Dependent on listed patents, labeling, and FDA approval pathway
Generic entry timing	Controlled by patent certifications, litigation outcomes, regulatory review, and commercial launch decisions

The commercial risk increases sharply when a generic applicant can file an abbreviated new drug application with a Paragraph IV certification against listed patents. Cangrelor’s short treatment duration and hospital-use economics may encourage a generic entrant to compete on contract price rather than pursue a large branded-to-generic conversion campaign.

What patents protect cangrelor and Kengreal?

Kengreal is a small-molecule product, so its protection can include composition-of-matter, formulation, manufacturing, and method-of-use patents. The Orange Book is the controlling source for patents listed against the approved NDA and should be read together with FDA patent and exclusivity records.

The relevant patent categories are:

Composition and active-ingredient patents

Composition patents provide the strongest theoretical protection but depend on their expiration dates, claim scope, validity, and whether the generic applicant can design around the claims. For an older molecule such as cangrelor, core compound protection is likely to be less important than later-issued formulation, dosing, or use claims.

Formulation and dosage-form patents

Cangrelor is supplied as an injectable lyophilized product. Potential formulation barriers can involve:

• Stabilized cangrelor compositions.
• Lyophilized powder characteristics.
• Reconstitution and dilution requirements.
• Storage stability.
• Container-closure systems.
• Concentration and infusion preparation.

Generic injectable applicants must demonstrate pharmaceutical equivalence, quality, sterility, stability, and bioequivalence or clinical equivalence under the applicable FDA pathway. Manufacturing and quality-control requirements can discourage small manufacturers even when patent barriers are limited.

Method-of-use patents

Method claims may cover administration during PCI, patient selection, dosing, or transitions between intravenous and oral P2Y12 therapy. Method-of-use claims can be important if they are listed in the Orange Book and if a generic applicant must address them through a Paragraph IV certification or a section viii statement.

The practical strength of method-of-use patents depends on whether the generic label can omit the protected indication or dosing instruction. Because cangrelor’s principal value is tied to PCI, a narrow carve-out may be commercially difficult even if legally available.

Manufacturing and process patents

Process patents may protect impurity controls, synthesis steps, crystallinity, or scalable production. They do not necessarily prevent a generic from entering if the applicant uses a non-infringing process. Their value is highest when the process is difficult to replicate and the finished-drug specification is tightly linked to the patented method.

What is the Orange Book status of Kengreal?

Kengreal is listed in FDA drug databases under NDA 207476. Orange Book status must be evaluated by reviewing the current entry for Kengreal, including listed patents, patent-use codes, expiration dates, and any delisting or dispute history.

The legal distinction is important:

• FDA exclusivity blocks approval for a defined period.
• Orange Book patents can delay approval or trigger patent litigation.
• A Paragraph IV certification can create a patent dispute before launch.
• A section viii statement can avoid certification for a patented use if the generic label omits that use.
• A generic injectable may still face manufacturing or regulatory delays after patent barriers expire.

No biosimilar pathway applies. Any entrant would be a generic or potentially a 505(b)(2) applicant, depending on the proposed product and reliance strategy.

Which companies are challenging cangrelor exclusivity?

Publicly available product information does not establish a major, widely reported Paragraph IV litigation campaign against Kengreal comparable with litigation involving high-revenue oncology, immunology, or diabetes products. The absence of a prominent case does not eliminate future generic risk. It indicates that the market may be less attractive to large generic companies because of limited volume, hospital contracting, sterile manufacturing requirements, and a specialized sales channel.

Potential entrant classes include:

• Large generic manufacturers with sterile injectable capacity.
• Hospital-focused injectable suppliers.
• Contract manufacturers seeking portfolio expansion.
• 505(b)(2) developers pursuing modified injectable presentations.

A generic entrant would likely evaluate the product on expected hospital contract value rather than retail prescription substitution.

What generic launch scenarios exist for cangrelor?

Three launch scenarios are commercially relevant.

Early launch after Paragraph IV litigation

A generic applicant could launch at risk before patent expiry after receiving FDA approval or resolving litigation. This would create immediate hospital price pressure and could force Chiesi to offer discounts or contracting concessions.

Launch after patent expiry

This is the most conservative scenario. Multiple suppliers could enter after the final enforceable patent expires, causing price erosion over several contracting cycles. The impact would depend on whether hospitals view the generic as fully interchangeable and whether supply reliability is proven.

Limited or delayed generic entry

A generic may receive approval but delay broad commercialization because the market is small, sterile injectable production is expensive, and hospital contracts require evidence of supply continuity. In this case, Kengreal could retain meaningful share despite loss of formal exclusivity.

What regulatory status does cangrelor have?

The FDA approved Kengreal for use during PCI in adults who have not been treated with a P2Y12 platelet inhibitor and are not receiving a glycoprotein IIb/IIIa inhibitor. The label includes dosing, contraindications, warnings, and transition instructions for oral P2Y12 therapy.

The regulatory profile supports use in a defined procedural niche but limits label-driven expansion. The most important safety issue is bleeding. Cangrelor is contraindicated in active pathological bleeding or a significant bleeding risk, and it should not be used in patients with a history of stroke or transient ischemic attack under the labeled restrictions (FDA, 2024a).

Clinical adoption is also influenced by guidelines. The 2021 ACC/AHA/SCAI coronary revascularization guideline describes cangrelor as an option in selected PCI patients, particularly when oral P2Y12 administration or absorption is not feasible. It does not establish universal routine use across all PCI procedures (Lawton et al., 2022).

How strong is the cangrelor patent estate?

Cangrelor’s patent estate is commercially moderate rather than dominant.

Its strengths are:

• Injectable formulation complexity.
• Specialized clinical use.
• Hospital procurement friction.
• Limited number of experienced sterile-injectable manufacturers.
• Dependence on reliable supply and cath-lab protocols.

Its weaknesses are:

• Expired NCE exclusivity.
• Mature clinical class with inexpensive oral alternatives.
• Narrow procedural indication.
• Limited outpatient demand.
• Potential for generic applicants to design around process or use claims.
• Low probability of biosimilar-style barriers because the molecule is not biologic.

The most important diligence issue is not the number of patents. It is whether any unexpired listed patent blocks a generic label covering the commercially essential PCI use.

What licensing and ownership deals affect cangrelor?

Cangrelor was developed before becoming a Chiesi commercial product and passed through multiple corporate ownership arrangements. The Medicines Company commercialized Kengreal after acquiring rights associated with the program, and Chiesi later acquired U.S. rights to Kengreal as part of a broader transaction involving The Medicines Company’s products.

The ownership history matters because patent ownership, regulatory sponsorship, commercialization rights, and manufacturing rights may be held by different entities. For diligence, the relevant commercial counterparty is Chiesi USA, while historical revenue and development data may appear in The Medicines Company filings.

What revenue exposure does cangrelor create for Chiesi?

Kengreal is strategically useful but unlikely to be a group-defining revenue driver for Chiesi. Its value is based on specialty-hospital positioning and durable procedural demand rather than rapid prescription growth.

Revenue exposure is concentrated in:

• U.S. PCI procedure volume.
• Hospital formulary retention.
• Price and discounting.
• Emergency and complex-case utilization.
• Generic injectable entry.
• Supply reliability.
• Clinical preference for intravenous therapy over crushed oral agents.

The product’s limited treatment duration reduces patient persistence risk but also caps annual revenue per patient. A hospital can use the product repeatedly across procedures, yet utilization remains tied to procedural volume rather than chronic cardiovascular prevalence.

How does cangrelor compare with ticagrelor and clopidogrel?

Factor	Cangrelor	Ticagrelor	Clopidogrel
Route	Intravenous	Oral	Oral
Onset	Immediate	Rapid but dependent on absorption	Slower and variable
Reversibility	Rapid offset	Longer pharmacologic effect	Irreversible platelet inhibition
Cost position	Premium hospital product	Branded or genericized oral therapy, depending on market	Low-cost generic
Main use	Selected PCI cases	Acute coronary syndrome and chronic post-PCI therapy	Broad PCI and secondary prevention
Best commercial attribute	Predictable procedural control	Potent oral therapy	Cost and familiarity
Main limitation	Narrow use and infusion requirement	Absorption and bleeding concerns	Variable response and delayed effect

Cangrelor is complementary to oral therapy in many treatment pathways. Patients may receive cangrelor during PCI and transition to an oral P2Y12 inhibitor for maintenance. This limits direct substitution but also means the product captures only the procedural segment of the treatment episode.

Key Takeaways

• Cangrelor is a specialized intravenous P2Y12 inhibitor marketed as Kengreal by Chiesi.
• Its commercial niche is immediate, reversible platelet inhibition during selected PCI procedures.
• The product competes mainly against oral P2Y12 therapy, crushed oral regimens, and intravenous glycoprotein IIb/IIIa inhibitors.
• FDA approval occurred on June 22, 2015; five-year NCE exclusivity would have ended in 2020.
• Chiesi does not publicly report a standalone Kengreal revenue series, limiting precise current financial forecasting.
• The product has no biosimilar risk because cangrelor is a small molecule.
• Generic risk is driven by Orange Book patents, sterile injectable manufacturing, hospital contracting, and the commercial attractiveness of the relatively narrow market.
• Patent strength is likely more dependent on formulation, use, and manufacturing claims than on new-chemical-entity exclusivity.
• A generic launch would likely pressure hospital pricing before it eliminated the product from formularies.
• Kengreal is a durable specialty-hospital asset, but its growth ceiling is constrained by selective use and inexpensive oral alternatives.

FAQs about cangrelor market and patent risk

Is cangrelor a biologic drug?

No. Cangrelor is a chemically synthesized small molecule. Future competitors would generally use an abbreviated generic pathway rather than a biosimilar pathway.

Can cangrelor be used instead of ticagrelor after PCI?

Cangrelor can provide temporary intravenous P2Y12 inhibition during PCI, but patients generally transition to an oral antiplatelet agent for ongoing treatment when clinically appropriate.

Why has cangrelor not become a routine drug for every PCI procedure?

Most PCI patients can receive oral clopidogrel, prasugrel, or ticagrelor. Cangrelor requires intravenous administration, adds cost, and carries bleeding risk, so hospitals reserve it for selected patients.

What is the most important manufacturing barrier for generic cangrelor?

The principal barrier is sterile injectable production with reliable reconstitution, stability, impurity control, and supply continuity. These requirements can make a low-volume generic commercially unattractive.

Is Kengreal revenue likely to grow faster than the overall PCI market?

Sustained growth would require increased penetration within PCI rather than only higher procedure volume. Adoption depends on hospital protocols, clinical evidence, price, and the availability of competing oral therapies.

References

1. Lawton, J. S., Tamis-Holland, J. E., Bangalore, S., Bates, E. R., Beckie, T. M., Bischoff, J. M., Bittl, J. A., Cohen, M. G., DiMaio, J. M., Don, C. W., Fremes, S. E., Gaudino, M. F., Goldberger, Z. D., Grant, M. C., Jaswal, J. B., Kurlansky, P. A., Mehran, R., Metkus, T. S., Nnacheta, L. C., Rao, S. V., Sellke, F. W., Sharma, G., Tamis-LeMonda, C. S., Ullah, W., & American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. (2022). 2021 ACC/AHA/SCAI guideline for coronary artery revascularization. Circulation, 145(3), e18-e114.

2. The Medicines Company. (2019). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2018. U.S. Securities and Exchange Commission.

3. The Medicines Company. (2020). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2019. U.S. Securities and Exchange Commission.

4. U.S. Food and Drug Administration. (2024a). Kengreal (cangrelor) for injection: Prescribing information. FDA.

5. U.S. Food and Drug Administration. (2024b). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. FDA.

6. U.S. Food and Drug Administration. (2015). FDA approves Kengreal to prevent blood clots during heart procedures. FDA.

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