LEXISCAN Drug Patent Profile

When do Lexiscan patents expire, and when can generic versions of Lexiscan launch?

Lexiscan is a drug marketed by Astellas and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in eighteen countries.

The generic ingredient in LEXISCAN is regadenoson. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the regadenoson profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lexiscan

A generic version of LEXISCAN was approved as regadenoson by ACCORD HLTHCARE on April 11^th, 2022.

Summary for LEXISCAN

International Patents:	28
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	47
Drug Prices:	Drug price information for LEXISCAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEXISCAN
What excipients (inactive ingredients) are in LEXISCAN?	LEXISCAN excipients list
DailyMed Link:	LEXISCAN at DailyMed

See drug prices for LEXISCAN

Recent Clinical Trials for LEXISCAN

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

Sponsor	Phase
St. Jude Children's Research Hospital	Phase 2
Emory University	N/A
Siemens Medical Solutions	N/A

See all LEXISCAN clinical trials

Pharmacology for LEXISCAN

Drug Class	Adenosine Receptor Agonist Pharmacologic Cardiac Stress Test Agent
Mechanism of Action	Adenosine Receptor Agonists

Paragraph IV (Patent) Challenges for LEXISCAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LEXISCAN	Injection	regadenoson	0.08 mg/mL, 5 mL vial	022161	1	2012-04-10

US Patents and Regulatory Information for LEXISCAN

LEXISCAN is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	AP	RX	Yes	Yes				Y
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	AP	RX	Yes	Yes			Y

Expired US Patents for LEXISCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008

EU/EMA Drug Approvals for LEXISCAN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
GE Healthcare AS	Rapiscan	regadenoson	EMEA/H/C/001176This medicinal product is for diagnostic use only.Rapiscan is a selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging (MPI) in adult patients unable to undergo adequate exercise stress.	Authorised	no	no	no	2010-09-06

International Patents for LEXISCAN

When does loss-of-exclusivity occur for LEXISCAN?

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

China

Japan

Mexico

New Zealand

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 LEXISCAN around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	024441	AGONISTAS DEL RECEPTOR A2A N-PIRAZOL, COMPOSICIONES FARMACEUTICAS Y EL USO DE LOS MISMOS PARA PREPARAR UN MEDICAMENTO.
Austria	256141
Australia	7132400
Australia	760806
Brazil	0011856	AGONISTAS DE RECEPTOR A2A DE N-PIRAZOL
Canada	2377746	AGONISTES DU RECEPTEUR A2A N-PYRAZOLE (N-PYRAZOLE A2A RECEPTOR AGONISTS)

Supplementary Protection Certificates for LEXISCAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1189916	C300477	Netherlands		PRODUCT NAME: REGADENOSON ALSMEDE FARMACEUTISCHE AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916	CA 2011 00005	Denmark		PRODUCT NAME: REGADENOSON OG SALTE DERAF
1189916	91785	Luxembourg		91785, EXPIRES: 20250621
1189916	SPC004/2011	Ireland		SPC004/2011: 20110719, EXPIRES: 20250620
1189916	1190003-2.L	Sweden		PRODUCT NAME: REGADENOSON OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/643/001 20100906
1189916	11C0004	France		PRODUCT NAME: REGADENOSON ET SES SELS; REGISTRATION NO/DATE: EU/1/10/643/001 20100906

LEXISCAN (regadenoson) market dynamics and financial trajectory: U.S. demand drivers, payer pressure, and exclusivity/patent-led generic timing

Last updated: July 26, 2026

LEXISCAN (regadenoson) is a niche cardiology diagnostic used for pharmacologic stress testing. The market has matured into a low-growth, supply-and-coverage-driven revenue stream, with pricing and utilization constrained by payer scrutiny, substitute access, and the long tail of generic entry after reference exclusivity. Financial performance is dominated by U.S. outpatient and hospital procurement cycles, competitive interchanges within nuclear stress testing workflows, and seasonal scheduling tied to elective cardiac diagnostic throughput.

Key market dynamics that shape revenue

• Utilization is clinical-protocol driven: drug choice is influenced by facility formulary policy, ordering physician practice, and cardiology lab standard operating procedures for imaging (typically nuclear perfusion).
• Coverage and reimbursement discipline: hospital outpatient departments and cardiology practices face recurring payment pressure for imaging services, which feeds back into drug procurement.
• Competitive interchange exists at the workflow layer: even when regadenoson remains the pharmacologic stress agent choice, procurement tends to be rationalized against alternatives that fit local protocols.
• Acquisition and supply continuity matter: shortages or allocation disruptions can temporarily lift realized revenue per unit; otherwise, pricing tends to compress toward average reimbursement and contract rates.
• Generic and label-access path drives pricing reset: once generic regadenoson becomes available at scale, reference pricing and channel margins typically erode quickly unless the brand holds managed-care coverage.

What is LEXISCAN (regadenoson) used for, and how does that drive demand?

Featured snippet answer: LEXISCAN is used to induce pharmacologic stress for diagnostic myocardial perfusion imaging in patients who cannot undergo adequate exercise stress. Demand tracks the volume of nuclear stress tests and cardiology lab protocol adoption.

How do cardiology diagnostic workflows translate into revenue?

• Procedure-linked sales: regadenoson is purchased by imaging-capable sites and cardiology centers, so revenue is a function of nuclear stress testing volumes and staffing capacity for elective diagnostics.
• Protocol standardization: centers often standardize regadenoson use to reduce variation in induction protocols and staff training.
• Patient selection: use concentrates in patients unable to exercise adequately, shaping demand relative to baseline cardiology imaging growth and referral patterns.

Which imaging settings contribute most to U.S. sales?

• Hospital outpatient departments and imaging centers that perform pharmacologic stress tests are the primary demand pools.
• High-volume cardiology groups and large hospital systems typically negotiate multi-quarter contracts that determine realized pricing.

What market dynamics influence LEXISCAN pricing and unit volumes?

Featured snippet answer: Pricing and volumes are jointly constrained by payer and procurement pressure, substitution practices within pharmacologic stress testing workflows, and the timing of generic competition.

What payer and procurement forces compress LEXISCAN realized price?

• Bundled imaging economics: reimbursement for diagnostic imaging services can be pressured through payer negotiations, which discourages premium drug spend.
• Contracting structure: large systems and group purchasing organizations negotiate rebates and access terms that can cap realized unit prices for branded supply.
• Formulary tiers and prior authorization practices: coverage policies often favor lowest-cost in-class options once multiple alternatives are present.

How do channel inventory and hospital purchasing cycles affect quarterly revenue?

• Sales move in steps tied to:
  • contract replenishment cycles
  • quarterly purchase orders from hospital pharmacy and cardiology labs
  • inventory build ahead of anticipated imaging schedules
• As competition increases, procurement tends to synchronize with the lowest contracted supplier.

What substitutes or competing stress agents pressure LEXISCAN?

• Competitive pressure arises from alternatives used in pharmacologic stress testing. While clinical substitution depends on patient-specific factors, procurement departments often compare total cost within the protocol options available in their systems.

When did exclusivity end for LEXISCAN, and when did generic regadenoson enter risk?

Featured snippet answer: Generic entry risk for regadenoson is driven by the end of reference exclusivity and the timing of ANDA approvals/launches. Once generics achieve broad supply, branded pricing typically declines rapidly.

How does exclusivity typically translate into financial inflection?

• Exclusivity end creates a structural path for:
  • ANDA filings during the tail of brand protection
  • Paragraph IV challenges that can delay or accelerate outcomes depending on litigation outcomes
  • ANDA launch after approval if settlements permit

What do settlement outcomes usually do to brand revenue?

• Settlement terms can cap branded losses by:
  • delaying generic launch
  • limiting label or formulation differences
• When settlements allow early launch, brand revenue typically experiences a sharper step-down in the year of entry.

What patents protect LEXISCAN, and how strong is the patent estate for market protection?

Featured snippet answer: The practical ability of LEXISCAN to maintain brand revenue depends on the continuing enforceability of listed Orange Book patents (composition, formulation, and method-related claims) and the outcome of any ANDA-related litigation.

How to read the LEXISCAN patent estate for R&D and licensing risk

• Composition-of-matter (if still enforceable) blocks broad generic entry.
• Formulation and manufacturing method patents can limit “at-risk” launch options.
• Method-of-use claims can create labeling constraints that influence generic launch design.

What is the litigation-driven risk profile?

• If multiple patents are asserted in ANDA litigation, the settlement matrix can:
  • produce staggered launch timing by product strength or presentation
  • define permitted labeling carve-outs
  • establish “design-around” pathways

What is the Orange Book status of LEXISCAN, and which listings matter for generic entry?

Featured snippet answer: Orange Book-listed patents determine the legal “map” for ANDA applicants. For brand protection, the operative risk is which patents remain listed and enforceable at the time of ANDA approval.

Which Orange Book elements usually govern exclusivity and launch timing?

• Patent list type:
  • Drug substance patents
  • Drug product patents
  • Method-of-use patents
• Expiration dates:
  • End of exclusivity and final patent expiration drive the last possible launch date.

How does LEXISCAN financial trajectory compare with other cardiology diagnostic brands?

Featured snippet answer: LEXISCAN’s financial trajectory is typical for mature, protocol-driven diagnostic drugs: modest demand growth, pricing pressure as alternatives expand, and step-down effects with generic entry.

What competitive pattern typically appears in this segment?

• Brands in imaging-adjacent pharmacology often see:
  • stable units early in lifecycle due to workflow preference
  • slower growth as formularies diversify
  • rapid margin compression following generic availability
  • periodic revenue fluctuations driven by tender cycles and short-term supply constraints

How does size and niche positioning affect revenue resilience?

• Niche therapeutic focus means:
  • fewer “volume offsets” when pricing compresses
  • higher sensitivity to protocol substitution and formulary changes
  • limited ability to absorb margin loss through broad expansion

How do biosimilar or biologic dynamics apply to LEXISCAN?

Featured snippet answer: Biosimilar dynamics do not apply because LEXISCAN is a small-molecule drug product (regadenoson), not a biologic.

What generic entry risks exist for LEXISCAN, and what launch scenarios matter commercially?

Featured snippet answer: The key commercial risks are generic ANDA approval outcomes, settlement-driven timing, and whether generics enter at scale with competitive pricing aligned to hospital contracts.

Which launch scenarios typically matter most to the brand

• Early launch under settlement: larger immediate price erosion.
• Staggered launch across strengths/presentations: delayed full price compression.
• Supply constraints for generic entrants: can slow brand losses temporarily.
• Label limitations: can preserve partial branded coverage in certain indications.

What manufacturing and IP barriers can slow generic penetration?

• Any remaining enforceable manufacturing or formulation constraints can raise costs or delay supply ramp-up for entrants.

What is the revenue exposure from U.S. sales versus international markets for LEXISCAN?

Featured snippet answer: LEXISCAN demand is primarily U.S.-anchored in strategy and market dynamics because exclusivity, Orange Book governance, and payer procurement structures are U.S.-specific.

How do international policies change financial trajectory?

• International markets can experience different:
  • local competitor timing
  • regulatory approvals
  • reimbursement discipline and contracting structures
• These differences can create revenue offsets, but the dominant inflection usually aligns with U.S. competition because it sets pricing benchmarks.

What does FDA regulatory status imply for LEXISCAN competitive positioning?

Featured snippet answer: FDA approval and labeling stability influence procurement confidence and the ability for generics to design around claims.

How does labeling affect generic launch feasibility?

• If labeling differences are relevant to method-of-use claims or risk mitigation, generic entrants can be constrained in launch timing or commercialization.

Key Takeaways

• LEXISCAN is a mature, workflow-linked cardiology diagnostic drug whose revenue is driven by nuclear stress test volumes and hospital formulary decisions.
• Pricing is pressured through imaging reimbursement dynamics, large-system contracting, and substitution behavior within pharmacologic stress testing options.
• Financial inflection is driven by generic competition timing, which depends on Orange Book-listed patents and any ANDA-related litigation/settlements.
• Biosimilar dynamics do not apply; the competitive frame is ANDA/generic small-molecule entry rather than biologic competition.
• Commercial risk management should focus on U.S. exclusivity endpoints, patent listing expirations, and settlement-defined launch timing that affects step-down magnitude in realized price.

FAQs

1) What factors most influence LEXISCAN formulary adoption at hospital cardiology labs?
Clinical protocol fit, contracting terms via group purchasing, and inventory reliability for pharmacologic stress testing workflows.

2) How quickly does LEXISCAN typically lose market share after generic entry?
Market share erosion usually accelerates once multiple generic suppliers secure contracts and supply ramp, with branded revenue stepping down as pricing resets.

3) What patent categories tend to be most relevant for ANDA challenges on small-molecule stress agents like regadenoson?
Drug product, formulation, and method-related patents listed in the Orange Book are often central to launch feasibility and labeling constraints.

4) Does LEXISCAN face different competition dynamics outside the U.S.?
Yes, because regulatory timelines and payer reimbursement structures vary by country, changing competitor timing and realized pricing.

5) Is LEXISCAN used for the same purpose as other pharmacologic stress testing agents?
It is used for pharmacologic stress in patients unable to exercise adequately for diagnostic myocardial perfusion imaging, but substitution depends on protocols and patient factors.

References

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 Labeling for LEXISCAN (regadenoson). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
3. FDA Drug Approval Reports: Drug Details for LEXISCAN (regadenoson). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm