PERSANTINE Drug Patent Profile

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

Persantine is a drug marketed by Boehringer Ingelheim and is included in one NDA.

The generic ingredient in PERSANTINE is dipyridamole. There are eighteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the dipyridamole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Persantine

A generic version of PERSANTINE was approved as dipyridamole by BARR on October 3^rd, 1990.

Summary for PERSANTINE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	9
Patent Applications:	4,413
What excipients (inactive ingredients) are in PERSANTINE?	PERSANTINE excipients list
DailyMed Link:	PERSANTINE at DailyMed

Recent Clinical Trials for PERSANTINE

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

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

See all PERSANTINE clinical trials

US Patents and Regulatory Information for PERSANTINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	PERSANTINE	dipyridamole	TABLET;ORAL	012836-003	Dec 22, 1986		DISCN	Yes	No
Boehringer Ingelheim	PERSANTINE	dipyridamole	TABLET;ORAL	012836-004	Feb 6, 1987		DISCN	Yes	No
Boehringer Ingelheim	PERSANTINE	dipyridamole	TABLET;ORAL	012836-005	Feb 6, 1987		DISCN	Yes	No

Persantine Market Dynamics, Patent Status, FDA Exclusivity, and Financial Trajectory

Last updated: August 4, 2026

Persantine is the original brand for dipyridamole, an antiplatelet and coronary vasodilator. Its commercial value has shifted from branded tablets to low-margin generic dipyridamole, hospital use in pharmacologic cardiac stress testing, and combination products such as aspirin/extended-release dipyridamole. The brand has no meaningful remaining market exclusivity in the United States, and no standalone Persantine revenue is publicly disclosed.

The commercial outlook is mature and structurally limited. Generic substitution, declining use of dipyridamole as a preferred stress agent, and competition from clopidogrel, direct oral anticoagulants, and regadenoson constrain growth. Value remains in reliable supply, hospital contracts, combination-product manufacturing, and niche clinical applications rather than in branded pricing power.

What is Persantine and how is dipyridamole used?

Persantine contains dipyridamole, a phosphodiesterase inhibitor and coronary vasodilator. Its clinical uses differ by dosage form and product configuration.

Product or use	Active ingredient	Primary clinical role	Current commercial position
Persantine tablets	Dipyridamole	Adjunct to warfarin in patients with prosthetic heart valves	Legacy brand; generic competition
Dipyridamole injection	Dipyridamole	Pharmacologic myocardial perfusion stress testing	Generic and hospital-oriented
Aggrenox	Aspirin plus extended-release dipyridamole	Secondary prevention after transient ischemic attack or ischemic stroke	Combination product with generic competition
Aspirin/ER dipyridamole capsules	Aspirin plus extended-release dipyridamole	Stroke prevention	Generic substitutes available
Dipyridamole in laboratory protocols	Dipyridamole	Platelet aggregation and vascular research	Small institutional market

The original Persantine oral indication was prevention of thromboembolic complications associated with prosthetic heart valves when used with coumarin anticoagulants. The product label does not position dipyridamole as a broad replacement for contemporary antiplatelet therapy in coronary or cerebrovascular disease (U.S. Food and Drug Administration [FDA], 2019).

What is the FDA regulatory status of Persantine?

Persantine is an established small-molecule prescription drug, not a biologic. Its regulatory pathway is an older new drug application rather than a modern abbreviated new drug application.

The principal regulatory distinctions are:

• Oral dipyridamole tablets are legacy products with generic equivalents.
• Intravenous dipyridamole is used for pharmacologic stress testing and is available through generic manufacturers.
• Aspirin/extended-release dipyridamole is regulated as a combination drug product.
• The product does not benefit from current chemical, biologic, or orphan-drug exclusivity.
• There is no biosimilar pathway because dipyridamole is a chemically synthesized small molecule.

The commercial question is therefore generic availability, manufacturing continuity, and institutional purchasing rather than FDA exclusivity.

What is the Orange Book status of Persantine?

Persantine’s commercial exclusivity has expired. The relevant economic effect is the availability of therapeutically equivalent dipyridamole products and the loss of branded pricing authority.

The FDA Orange Book remains the primary source for current reference-listed-drug and therapeutic-equivalence information. Historical Persantine products may appear differently from currently marketed products because companies can discontinue a brand while generic approvals remain active. A discontinued brand does not eliminate the underlying generic market or prevent continued regulatory maintenance by approved manufacturers (FDA, 2024a).

No active, commercially meaningful Orange Book patent estate is associated with the legacy Persantine franchise based on the drug’s age, generic availability, and long-established use. Current competitors are unlikely to face a branded patent barrier for immediate-release dipyridamole tablets.

When did Persantine lose market exclusivity?

Persantine lost practical market exclusivity decades ago. The original product was introduced in the mid-20th century, and any composition-of-matter or early formulation protection would have expired before the modern generic-drug market developed.

Exclusivity category	Persantine position
New chemical entity exclusivity	Expired
Original composition patent protection	Expired
Oral tablet formulation protection	Expired or commercially irrelevant
Pediatric exclusivity	None of material current value
Orphan exclusivity	None
Current branded market exclusivity	None of material value
Biosimilar exclusivity	Not applicable

The effective loss of exclusivity occurred through the expiration of early patents and the subsequent approval of generic dipyridamole products. Exact historical patent dates are less relevant to present valuation than the absence of a live blocking estate.

What patents protect Persantine and dipyridamole today?

No significant active patent barrier appears to protect the original Persantine oral tablet franchise. The remaining intellectual-property value is more likely to reside in product-specific technologies involving release profile, combination composition, manufacturing process, or packaging.

Potentially relevant patent categories include:

1. Extended-release dipyridamole formulations.
2. Aspirin/dipyridamole fixed-dose combinations.
3. Modified-release beads or multiparticulate capsules.
4. Manufacturing processes and impurity controls.
5. Stability systems and container-closure configurations.
6. New combinations with antithrombotic agents.

These rights would apply to a particular formulation or product configuration, not necessarily to immediate-release dipyridamole itself. A patent covering aspirin/extended-release dipyridamole would not automatically block a generic immediate-release Persantine tablet.

Patent risk should be assessed at the product level through the FDA Orange Book, USPTO records, product labeling, and ANDA litigation records. A broad statement that “dipyridamole is patented” would be commercially inaccurate.

What formulation patents protect aspirin/extended-release dipyridamole?

The most commercially relevant formulation protection has historically involved extended-release dipyridamole combined with aspirin. Aggrenox was developed to provide sustained dipyridamole exposure with aspirin for secondary stroke prevention.

Formulation-related barriers can affect:

• Release kinetics.
• Capsule architecture.
• Drug-layer or bead technology.
• Dose uniformity.
• Stability of aspirin in combination.
• Bioequivalence testing.
• Manufacturing reproducibility.

These barriers can delay or increase the cost of generic development even after the original active ingredient is unprotected. They do not restore the pricing power of the Persantine brand because the value is attached to a separate modified-release combination product.

Generic aspirin/extended-release dipyridamole products have materially reduced the commercial value of the branded combination. The remaining market depends on prescription habits, payer substitution rules, physician familiarity, and supply reliability.

Are there Paragraph IV challenges against Persantine?

Paragraph IV litigation risk for immediate-release Persantine is low because the underlying product is old and generic competition is established. Paragraph IV challenges are more relevant to branded modified-release or combination products than to the legacy Persantine tablet.

Under the Hatch-Waxman framework, an ANDA applicant can certify that a listed patent is invalid, unenforceable, or will not be infringed. A Paragraph IV certification can trigger patent litigation and a potential 30-month stay of approval, subject to statutory conditions (FDA, 2024b).

For Persantine-related products, the practical hierarchy is:

Product	Paragraph IV exposure	Commercial significance
Immediate-release dipyridamole tablets	Low	Mature generic market
Dipyridamole injection	Low to moderate	Supply and hospital contracting matter more
Aspirin/ER dipyridamole	Historically higher	Formulation and bioequivalence issues
New dipyridamole combinations	Product-specific	Depends on patent scope and clinical positioning

No current, widely material Persantine-specific litigation dominates the commercial outlook.

What patent litigation affects Persantine and dipyridamole?

The most important litigation risk is not a challenge to the dipyridamole molecule. It is the potential enforcement of patents covering a branded combination, delivery system, or manufacturing method.

Litigation analysis should separate:

• Patent validity disputes.
• Infringement disputes over modified-release formulations.
• Regulatory disputes over labeling and carve-outs.
• Contract disputes involving supply or licensing.
• Product-liability litigation, which is distinct from patent litigation.

The absence of a major current patent case reinforces the conclusion that Persantine is a mature generic asset. Litigation reserves, legal expenses, and launch timing are more relevant for aspirin/extended-release dipyridamole competitors than for immediate-release tablets.

Which companies compete with Persantine?

Persantine competes across several therapeutic and product markets rather than against a single branded rival.

Antiplatelet competition

The main alternatives for vascular event prevention include:

• Clopidogrel.
• Aspirin.
• Ticagrelor.
• Prasugrel in selected acute coronary syndrome settings.
• Aspirin plus extended-release dipyridamole for selected stroke-prevention patients.

Clopidogrel is generally more important commercially than dipyridamole in broad antiplatelet prescribing because of clinical familiarity, low cost, once-daily dosing, and extensive guideline use.

Anticoagulant competition

In patients requiring anticoagulation, direct oral anticoagulants and warfarin influence treatment selection. The historical Persantine indication involving prosthetic heart valves is narrow and does not create a broad antithrombotic growth market.

Cardiac stress-testing competition

For pharmacologic myocardial perfusion imaging, regadenoson has become a major competitor to dipyridamole. Adenosine and dobutamine also remain relevant in selected settings. Regadenoson’s bolus administration and operational convenience have reduced the attractiveness of dipyridamole in many cardiac-imaging departments.

How does Persantine compare with clopidogrel and regadenoson?

Attribute	Persantine/dipyridamole	Clopidogrel	Regadenoson
Main market	Legacy antiplatelet and stress testing	Antiplatelet therapy	Pharmacologic cardiac stress testing
Molecular type	Small molecule	Small molecule	Small molecule
Patent status	Mature generic	Mature generic	Branded and generic dynamics vary by market
Administration	Oral or intravenous	Oral	Intravenous bolus
Main commercial buyer	Retail pharmacy and hospitals	Retail pharmacy and hospitals	Hospitals and imaging centers
Growth profile	Flat to declining	Large mature market	More durable stress-testing position
Main barrier	Clinical substitution and low price	Generic competition	Workflow, reimbursement, and product access

Dipyridamole has lower commercial leverage than clopidogrel in antiplatelet therapy and lower procedural convenience than regadenoson in stress imaging. Its remaining value is tied to low cost, established protocols, and limited clinical niches.

What are Persantine’s market dynamics?

Persantine operates in a mature generic market with five dominant forces.

Generic price erosion

Multiple suppliers can compete for immediate-release tablets and injectable dipyridamole. Prices tend to decline as additional manufacturers enter, although shortages can temporarily reverse that pattern.

Hospital procurement

Injectable dipyridamole is purchased through hospital formularies, group purchasing organizations, and distributor channels. Contract awards, manufacturing reliability, and backorder history can matter more than brand recognition.

Clinical substitution

Dipyridamole faces substitution by clopidogrel in antiplatelet therapy and by regadenoson in pharmacologic stress testing. Substitution limits volume growth even where the drug remains clinically acceptable.

Combination-product economics

Aspirin/extended-release dipyridamole has higher technical and regulatory complexity than immediate-release tablets. That complexity can support higher gross margins for capable manufacturers, but generic competition limits long-term pricing.

Supply-chain concentration

Small generic markets can be vulnerable to manufacturing interruptions. A product with low unit price may still be strategically important to hospitals if few suppliers remain. This creates episodic pricing opportunities but not durable branded economics.

What is Persantine’s financial trajectory?

No standalone public revenue series for Persantine is available from the major public-company reporting systems. Manufacturers generally report dipyridamole within broader generic, hospital, or cardiovascular portfolios.

The financial trajectory can be characterized as follows:

Period	Financial profile
Original branded period	Protected pricing and physician recognition
Early generic period	Rapid price and share erosion
Mature generic period	Low revenue per unit, stable niche demand
Current period	Supply-driven economics with limited growth
Forward outlook	Flat to declining core demand, with episodic hospital-market upside

Revenue exposure is concentrated in three areas:

1. Immediate-release oral dipyridamole, where unit economics are weak.
2. Injectable dipyridamole, where hospital demand and supply continuity are more important.
3. Aspirin/extended-release dipyridamole, where formulation complexity can improve economics but competition remains substantial.

Persantine is therefore unlikely to be a material growth driver for a diversified pharmaceutical company. It can contribute predictable base revenue, but its strategic value is usually defensive or operational rather than innovative.

What licensing deals involve Persantine or dipyridamole?

The original Persantine franchise was associated with legacy commercial rights rather than a current high-value licensing platform. Modern licensing value is more likely to attach to:

• Regional rights to aspirin/extended-release dipyridamole.
• Contract manufacturing.
• Hospital distribution.
• Combination-product technology.
• Reformulated cardiovascular products.

No major current licensing transaction is central to the commercial outlook for immediate-release Persantine. A transaction involving dipyridamole would likely be evaluated as a portfolio or supply deal rather than as a platform acquisition.

What generic launch risks exist for Persantine?

Generic launch risk is low for immediate-release tablets but higher for modified-release combinations and injectable products.

Key risks include:

• Bioequivalence failure for extended-release products.
• Manufacturing deviations affecting dissolution or stability.
• Limited market size after launch.
• Price collapse after multiple approvals.
• Hospital contract displacement.
• Drug-shortage exposure.
• Difficulty achieving reliable active-pharmaceutical-ingredient supply.
• Regulatory changes affecting discontinued or low-volume products.

A generic entrant can obtain approval and still produce limited returns if the market has several approved suppliers and low reimbursement.

How strong is the patent estate for Persantine?

The patent estate is weak for the original drug and potentially moderate for selected reformulations.

Asset type	Patent strength	Commercial assessment
Dipyridamole molecule	Very low	Long expired
Immediate-release tablet	Very low	Generic substitution
Injectable dipyridamole	Low	Process and supply barriers may matter
Aspirin/ER dipyridamole	Low to moderate	Formulation-specific protection
New delivery technology	Product-specific	Depends on claims and regulatory differentiation
Manufacturing know-how	Moderate operational value	May support quality and supply reliability

The most defensible assets are manufacturing controls, regulatory execution, and distribution relationships. These are practical barriers, not broad exclusionary patent rights.

What is the geographic coverage of Persantine?

Dipyridamole has broad international availability, but brand status, approved indications, dosage forms, and reimbursement differ by jurisdiction.

• United States: mature generic market with limited brand value.
• European Union: generic dipyridamole and combination products compete under national reimbursement systems.
• United Kingdom: prescribing is shaped by National Health Service formularies and stroke-prevention guidance.
• Emerging markets: brand recognition may persist, but pricing is generally constrained.
• Hospital markets: injectable availability can vary substantially by country.

International value depends on registration maintenance, local manufacturing, tender access, and distributor relationships. A product may have regulatory approval in a market without generating meaningful commercial revenue.

Key takeaways

• Persantine is the legacy brand for dipyridamole and has no meaningful remaining U.S. market exclusivity.
• Immediate-release tablets are mature generic products with low pricing power.
• Aspirin/extended-release dipyridamole has greater formulation complexity but remains exposed to generic competition.
• Regadenoson has weakened dipyridamole’s position in pharmacologic cardiac stress testing.
• Clopidogrel and aspirin limit growth in antiplatelet therapy.
• No biosimilar risk exists because dipyridamole is a small molecule.
• Current value is concentrated in hospital supply, generic manufacturing, and combination-product execution.
• Standalone Persantine revenue is not publicly reported, so financial analysis must use portfolio-level or product-market estimates.
• The patent estate is weak for the original molecule and stronger only for specific formulations or manufacturing processes.
• The forward financial profile is mature, low-growth, and vulnerable to price erosion and clinical substitution.

FAQs about Persantine market value and exclusivity

Is Persantine still sold in the United States?

Dipyridamole remains available in the United States through generic oral and injectable products. The original Persantine brand has limited commercial significance compared with generic dipyridamole.

Is dipyridamole the same drug as Persantine?

Yes. Persantine is a brand name for dipyridamole. Product differences can involve dosage strength, route of administration, release profile, manufacturer, and combination with aspirin.

Can a generic company launch dipyridamole without a Paragraph IV challenge?

For an unpatented or non-blocked product, an ANDA applicant may use a Paragraph III certification or a Paragraph I certification, depending on the patent and regulatory record. A Paragraph IV certification is required only when the applicant challenges an applicable listed patent.

Does Persantine have a role in stroke prevention?

Dipyridamole has a role in selected stroke-prevention regimens, particularly in combination with aspirin in extended-release products. Treatment selection depends on clinical history, tolerability, adherence, and guideline recommendations.

Why has dipyridamole lost share in cardiac stress testing?

Dipyridamole requires infusion and can produce prolonged pharmacologic effects. Regadenoson’s bolus administration and workflow advantages have supported substitution in many imaging centers.

References

1. U.S. Food and Drug Administration. (2019). Persantine (dipyridamole) tablets prescribing information.
2. U.S. Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (2024b). Hatch-Waxman amendments and abbreviated new drug applications.
4. U.S. Food and Drug Administration. (2023). Aggrenox (aspirin and extended-release dipyridamole) prescribing information.
5. National Institute for Health and Care Excellence. (2023). Stroke and transient ischaemic attack in over 16s: Diagnosis and initial management.
6. American Society of Nuclear Cardiology. (2010). Standardized reporting of radionuclide myocardial perfusion images. Journal of Nuclear Cardiology, 17(4), 607-624.