When do the patents on IV PERSANTINE expire, and when will generic IV PERSANTINE be available?

Sponsor	Phase
Guo-Qing Jiang	N/A
Peking University First Hospital	Phase 1/Phase 2
Affiliated Hospital of Yunnan University of Traditional Chinese Medicine	Phase 1/Phase 2

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	IV PERSANTINE	dipyridamole	INJECTABLE;INJECTION	019817-001	Dec 13, 1990		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: August 2, 2026

IV Persantine is the injectable formulation of dipyridamole, historically marketed in the United States by Boehringer Ingelheim and used primarily as a pharmacologic stress agent for myocardial perfusion imaging. Its commercial position is mature and largely generic. The product has no meaningful composition-of-matter exclusivity, limited differentiation, and demand tied to hospital nuclear cardiology volumes. Regadenoson and adenosine have reduced its role in cardiac stress testing.

Public filings do not disclose standalone revenue for IV Persantine. Its financial trajectory is best characterized as a low-growth, price-sensitive hospital injectable market with declining branded relevance and continuing generic demand.

What is IV Persantine and how is it used?

IV Persantine contains dipyridamole, a coronary vasodilator administered intravenously before myocardial perfusion imaging. The FDA-approved use is as an adjunct to myocardial perfusion imaging in patients who cannot exercise adequately. Dipyridamole increases coronary blood flow and produces perfusion heterogeneity that can be detected by radionuclide imaging.[1]

The injectable product is generally supplied at a concentration of 5 mg/mL. Dosing is weight-based and administered by intravenous infusion. Aminophylline or another methylxanthine may be used to reverse persistent or severe pharmacologic effects, although routine prophylactic reversal is not generally used.[1]

Primary clinical uses

Use	Commercial relevance
Pharmacologic myocardial perfusion imaging	Core approved use
Stress testing in patients unable to exercise	Established hospital use
Coronary steal evaluation	Limited and specialized
Thrombotic or platelet-related uses	Primarily associated with oral dipyridamole, not IV Persantine
Pediatric cardiac stress testing	Specialist and institution-specific

IV dipyridamole should be distinguished from oral Persantine, which has historically been used with warfarin in prosthetic heart valve patients and in other antiplatelet settings. The clinical and commercial markets are different.

What is the FDA regulatory status of IV Persantine?

The original US product was approved under NDA 018080 for Persantine Injection. Current US availability is dominated by generic dipyridamole injection products rather than a differentiated branded franchise.[2]

The FDA labeling identifies the product as an intravenous pharmacologic stress agent. Key safety considerations include hypotension, bronchospasm, chest pain, arrhythmias and adverse reactions related to coronary vasodilation. Patients with severe reactive airway disease or unstable cardiovascular conditions require particular caution.[1]

FDA status and product characteristics

Attribute	IV Persantine
Active ingredient	Dipyridamole
Route	Intravenous
Typical strength	5 mg/mL
Primary indication	Adjunct to myocardial perfusion imaging
Regulatory pathway	Original NDA plus generic ANDAs
Reference product	Persantine Injection
Current market structure	Generic and hospital-supply driven
Biologic status	Not applicable

FDA drug databases and DailyMed identify dipyridamole injection products as prescription injectable drugs. The product is not a biologic and is not subject to biosimilar substitution or the Biologics Price Competition and Innovation Act.[2,3]

When does IV Persantine lose exclusivity?

IV Persantine lost meaningful market exclusivity decades ago. Dipyridamole is an old small-molecule active ingredient, and generic injectable versions have been available for many years.

The commercial exclusivity analysis is therefore different from that of a recently approved branded drug:

Exclusivity category	Status
Composition-of-matter patent	Expired or commercially irrelevant
New chemical entity exclusivity	Expired
Pediatric exclusivity	No current commercial significance identified
Orphan exclusivity	Not applicable
Generic approval barriers	Low relative to new injectable drugs
Active Orange Book patent protection	No material active protection identified for the legacy product

The relevant competitive barriers are manufacturing, sterile quality systems, supply reliability, hospital contracting and regulatory compliance. Those barriers can limit the number of active suppliers even when patent protection is absent.

What patents protect IV Persantine?

No active US patent estate appears to provide meaningful exclusivity for the dipyridamole injection product. Historical patents associated with dipyridamole, its use or older formulations have expired or no longer prevent generic competition.

Formulation patents

The injectable formulation is technically simple relative to liposomal products, depot injections or complex biologics. It generally consists of dipyridamole in an aqueous injectable vehicle with excipients supporting pH, solubility and stability.

Potential formulation claims could cover:

Concentration and dosing format
Solubilizing agents
pH control
Container-closure systems
Stability specifications
Manufacturing or sterilization conditions

These features can support regulatory approval and quality control but are unlikely to create durable commercial exclusivity unless protected by an unexpired patent. Generic manufacturers can often design around narrow formulation claims or rely on established injectable technology.

Method-of-use patents

The principal use, pharmacologic stress testing for myocardial perfusion imaging, is longstanding. Any historical method-of-use protection would not be expected to block current generic sales. Hospitals and physicians can also use alternative stress agents, reducing the practical value of narrow method-of-use claims.

How many patents cover IV Persantine?

The commercially relevant number of active US patents is effectively zero for the legacy IV Persantine product. Patent counts can vary depending on whether expired, abandoned, foreign or formulation-related documents are included. Such documents do not create current US generic-entry barriers.

The patent estate is materially weaker than estates for newer specialty injectables. There is no evident patent-layering strategy involving multiple delivery devices, extended-release forms, combination products or protected manufacturing platforms.

What is the Orange Book status of IV Persantine?

The Orange Book is relevant because it records approved drug products, therapeutic-equivalence evaluations and certain patent or exclusivity information submitted by sponsors.[4]

For IV Persantine, the commercial significance of the Orange Book is limited:

The reference product is an old injectable NDA.
Generic dipyridamole injection products can compete through ANDA approvals.
No material active patent listing is expected to delay routine generic entry.
Orange Book status does not establish that a branded Persantine product has meaningful current sales.

The Orange Book also does not provide product-level revenue, hospital purchasing volume or a complete account of supply disruptions.

Which companies compete with IV Persantine?

Competition comes from both generic dipyridamole suppliers and substitute pharmacologic stress agents.

Direct generic competition

Generic dipyridamole injection suppliers can compete on:

Acquisition cost
National wholesaler availability
Hospital group purchasing contracts
Vial configuration
Back-order performance
Regulatory inspection history
Ability to maintain sterile manufacturing

Supplier participation may fluctuate because low-volume sterile injectables can be unattractive when manufacturing costs, quality requirements and inventory obligations exceed achievable pricing.

Therapeutic substitutes

Product	Active ingredient	Main competitive advantage
IV Persantine	Dipyridamole	Established experience and potentially low acquisition cost
Adenosine injection	Adenosine	Rapid onset and short duration
Lexiscan	Regadenoson	Single-bolus administration and selective A2A activity
Dobutamine	Dobutamine	Alternative stress modality when vasodilators are unsuitable

Regadenoson has been the strongest commercial substitute in nuclear cardiology because it is administered as a rapid bolus and has operational advantages in imaging centers. Adenosine remains relevant where cost, protocol familiarity or institutional preference favors it. Dobutamine is generally used when vasodilator stress agents are inappropriate.

How strong is the patent estate for IV Persantine?

The patent estate is weak. Its commercial defensibility depends on supply-chain execution rather than intellectual property.

Patent-strength factor	Assessment
Active composition patent	None of meaningful commercial relevance
Formulation complexity	Low to moderate
Device protection	Minimal
Method-of-use protection	Weak or expired
Generic design-around risk	High
Manufacturing barriers	Moderate
Regulatory compliance burden	Moderate to high
Litigation leverage	Low

Sterile injectable manufacturing creates more practical friction than an oral tablet. A manufacturer must demonstrate control of sterility, particulate matter, container integrity, potency, impurities and stability. These requirements can reduce supplier count but do not normally support premium pricing without scarcity.

What generic entry risks exist for IV Persantine?

Generic entry risk is already realized rather than prospective. The product has operated in a generic environment for years.

The main risks to branded or legacy commercial value are:

Generic price erosion
Substitution by regadenoson
Hospital protocol migration
Reduced nuclear stress-testing volumes
Manufacturer discontinuation
Temporary shortages or allocation events
Contract concentration among large suppliers

The main risk for generic suppliers is not Paragraph IV litigation. It is margin compression and unreliable demand forecasting.

Have there been Paragraph IV challenges or litigation?

No major, commercially material Paragraph IV campaign is associated with IV Persantine in the public record. That outcome is consistent with the product's age and absence of valuable active patent protection.

A Paragraph IV certification is most relevant when an ANDA applicant challenges an unexpired Orange Book patent. For an old dipyridamole injection product with no meaningful active patent barrier, an ANDA applicant has little reason to create a high-value patent dispute.

No significant settlement agreement is known to have shaped the US generic-entry timeline for IV Persantine. Litigation exposure is more likely to arise from ordinary product liability, supply contracts, manufacturing disputes or regulatory compliance than from patent enforcement.

What is the financial trajectory for IV Persantine?

IV Persantine is a mature, low-growth product. Its financial trajectory has four defining characteristics:

Branded revenue has limited strategic importance.
Generic pricing controls most market economics.
Demand is linked to imaging procedure volumes rather than new clinical adoption.
Substitution by regadenoson limits pricing power.

Public company reports generally aggregate injectable products into broader hospital, generic or pharmaceutical segments. They do not typically report IV Persantine revenue separately. A standalone market size or annual sales figure therefore cannot be reliably derived from public issuer filings.

Revenue drivers

Hospital demand is influenced by:

Number of pharmacologic myocardial perfusion studies
Relative use of dipyridamole, adenosine and regadenoson
Medicare and commercial reimbursement for nuclear imaging
Hospital pharmacy formulary decisions
Generic contract pricing
Product availability

Revenue pressure

The product faces structural pressure from:

Mature clinical use
Low switching costs for hospitals
Multiple pharmacologic substitutes
Lack of patent protection
Limited brand differentiation
Procurement-driven purchasing
Potentially low absolute annual volume per institution

Financial outlook

The most probable trajectory is stable-to-declining nominal revenue for the overall dipyridamole injection category, with episodic price increases during shortages. A supplier with dependable availability can achieve temporary share gains, but sustained premium pricing would require a supply disruption, a meaningful formulation improvement or a differentiated clinical protocol.

What manufacturing and geographic barriers affect IV Persantine?

The major manufacturing barrier is sterile injectable production. Facilities must comply with current good manufacturing practice requirements for aseptic processing, environmental monitoring, validation, container closure and batch release.

Geographic commercial exposure is concentrated in markets with:

Nuclear cardiology infrastructure
Reimbursement for myocardial perfusion imaging
Hospital pharmacy purchasing systems
Established generic injectable distribution
Local regulatory approval for dipyridamole injection

The United States remains commercially important because of its large hospital market and established cardiac imaging base. Europe and other developed markets have their own regulatory and reimbursement structures, while product availability may vary by country. Foreign patent protection is unlikely to be a central issue because the underlying active ingredient and principal use are old.

How does IV Persantine compare with regadenoson?

Regadenoson has a stronger commercial position in many contemporary imaging protocols.

Attribute	IV Persantine	Regadenoson
Administration	Infusion	Single bolus
Receptor profile	Less selective vasodilator	Relatively selective A2A agonist
Workflow	More preparation and monitoring	Faster protocol execution
Brand differentiation	Low	Historically higher
Generic pressure	High	Increasing after generic entry
Aminophylline reversal	May be required	May be used selectively
Hospital adoption	Mature and declining in some settings	Stronger recent positioning

Generic regadenoson has weakened the branded product's historical pricing advantage, but its administration profile remains attractive to imaging centers. IV Persantine retains a role where protocols, supply and acquisition cost support continued use.

Key Takeaways

IV Persantine is injectable dipyridamole used mainly for pharmacologic myocardial perfusion imaging.
The product is a mature generic-market drug with no meaningful active US patent estate.
Paragraph IV litigation and patent settlements are not major commercial factors.
Biosimilar risk does not apply because dipyridamole is a small molecule.
Regadenoson and adenosine are the main therapeutic substitutes.
Revenue is driven by imaging volumes, hospital contracts and supply availability.
Public filings do not report standalone IV Persantine revenue.
Sterile manufacturing and reliable supply are more important than intellectual property.
The likely long-term trajectory is flat to declining demand, with temporary pricing volatility during shortages.

FAQs about IV Persantine market exclusivity and commercial risk

Is IV Persantine still sold under the Persantine brand?

The US market is primarily supplied through generic dipyridamole injection products. Brand availability and commercial distribution can vary by supplier and period.

Can a generic manufacturer launch IV dipyridamole without challenging a patent?

Yes. The absence of a meaningful unexpired patent barrier means an ANDA applicant generally does not need to rely on a high-value Paragraph IV challenge to enter the market.

Is dipyridamole injection subject to drug-shortage risk?

Yes. Low-volume sterile injectables can experience shortages when manufacturing interruptions, quality investigations, raw-material constraints or supplier exits reduce capacity.

Does IV Persantine have an orphan-drug market?

No established orphan-drug exclusivity applies to the standard IV dipyridamole myocardial perfusion imaging product.

Which product is more commercially attractive, IV Persantine or regadenoson?

Regadenoson generally has stronger workflow differentiation, while IV Persantine can compete on established use and acquisition cost. For manufacturers, neither product offers the patent economics of a newly launched protected drug.

References

U.S. Food and Drug Administration. (2011). Persantine injection prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018080s052lbl.pdf
U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/
National Library of Medicine. (n.d.). DailyMed: Dipyridamole injection. https://dailymed.nlm.nih.gov/dailymed/
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	9
Patent Applications:	4,764
DailyMed Link:	IV PERSANTINE at DailyMed

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