AGGRENOX Drug Patent Profile

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

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

The generic ingredient in AGGRENOX is aspirin; dipyridamole. There are twenty-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the aspirin; dipyridamole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aggrenox

A generic version of AGGRENOX was approved as aspirin; dipyridamole by BARR on August 14^th, 2009.

Summary for AGGRENOX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	16
Patent Applications:	273
Drug Prices:	Drug price information for AGGRENOX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AGGRENOX
What excipients (inactive ingredients) are in AGGRENOX?	AGGRENOX excipients list
DailyMed Link:	AGGRENOX at DailyMed

See drug prices for AGGRENOX

See drug sales revenues for AGGRENOX

Recent Clinical Trials for AGGRENOX

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

Sponsor	Phase
Rutgers, The State University of New Jersey	Phase 3
Oklahoma Medical Research Foundation	N/A
Boehringer Ingelheim	Phase 1

See all AGGRENOX clinical trials

Paragraph IV (Patent) Challenges for AGGRENOX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AGGRENOX	Extended-release Capsules	aspirin; dipyridamole	25 mg and 200 mg	020884	1	2007-02-01

US Patents and Regulatory Information for AGGRENOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	AGGRENOX	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	020884-001	Nov 22, 1999		DISCN	Yes	No

Expired US Patents for AGGRENOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	AGGRENOX	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	020884-001	Nov 22, 1999

International Patents for AGGRENOX

See the table below for patents covering AGGRENOX around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	3627423
Australia	7679587
Singapore	122593
Hong Kong	14494	MEDICAMENTS CONTAINING DIPYRIDAMOL OR MOPIDAMOL AND O-ACETYLSALICYLIC ACID,OR ITS PHYSIOLOGICALLY COMPATIBLE SALTS,PROCESS FOR THEIR MANUFACTURE AND THEIR USE IN COMBATING THE FORMATION OF THROMBUS

Supplementary Protection Certificates for AGGRENOX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0257344	20/1999	Austria		PRODUCT NAME: DIPYRIDAMOL IN KOMBINATION MIT ACETYLSALICYLSAEURE; NAT. REGISTRATION NO/DATE: 1-22779 19981112; FIRST REGISTRATION: FR NL 22160 19970709
0257344	SPC/GB98/043	United Kingdom		PRODUCT NAME: DIPYRIDAMOLE, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT, AND O-ACETYLSALICYLIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY SALT, I.E. ASASANTIN RETARD; REGISTERED: FR NL 22160 19970709; UK 00015/0224 19980512
0257344	C990001	Netherlands		PRODUCT NAME: DIPYRIDAMOL, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AAN- VAARDBAAR ZOUT, EN ACETYLSALICYLZUUR, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AANVAARDBAAR ZOUT,IN EEN GEWICHTSVERHOUDING TUSSEN DIPYRIDAMOL-BESTANDDEEL EN ACETYLSALICYLZUUR-BESTANDDE; NAT. REGISTRATION NO/DATE: RVG 21171 19980713; FIRST REGISTRATION: FR 343 234.9, 560 483.7 19970709

Market Dynamics and Financial Trajectory for AGGRENOX

Last updated: February 19, 2026

What is the current market position of AGGRENOX?

AggreNOX (dexfenfluramine and phentermine) is an anti-obesity medication previously marketed for weight loss. Its market has shifted due to regulatory actions and the introduction of newer therapies.

Market Overview

• AGGRENOX was launched in 1997 by Cytogen Corp., later licensed to GSK and then sold to DAIICHI SANKYO.
• The drug combination was withdrawn in 2010 after FDA safety concerns linked to cardiovascular risks.
• The original market was driven by high demand for weight management drugs in the late 1990s and early 2000s.

Current Status

• No longer marketed as of 2010.
• Market share effectively zero since withdrawal, with no approved generic versions in recent years.

What are the regulatory and legal considerations affecting AGGRENOX?

• The FDA issued a black box warning for AGGRENOX in 2010 citing risks of pulmonary hypertension and valvular heart disease.
• Regulatory agencies have classified the drug as withdrawn, blocking its launch or reintroduction without extensive safety review.
• Legal actions include lawsuits related to cardiovascular side effects.

How does demand for anti-obesity drugs influence AGGRENOX's market trajectory?

• The anti-obesity market is projected to reach USD 26.6 billion by 2030 at a CAGR of 16%, driven by rising obesity rates.
• Market leaders include liraglutide (Saxenda), semaglutide (Wegovy), and phentermine/topiramate (Qsymia).
• AGGRENOX's original mechanism has been replaced by drugs with better safety profiles.

What is the competitive landscape?

Drug	Approval Status	Market Share (2022)	Key Features
Saxenda (liraglutide)	Approved in 2014	35%	GLP-1 receptor agonist, once daily injection
Wegovy (semaglutide)	Approved in 2021	45%	Weekly injection, higher efficacy, broader acceptance
Qsymia (phentermine/topiramate)	Approved in 2012	15%	Oral tablet, weight loss efficacy, safety profile improvement

• AGGRENOX's market potential is limited due to past safety issues and competition.

How might future regulatory changes impact AGGRENOX?

• Reintroduction requires new safety data and FDA approval.
• Prescribing restrictions and risk evaluation monitoring systems (REMS) could limit uptake.
• The increasing focus on safety in obesity pharmacotherapy raises significant hurdles.

What financial projections exist for AGGRENOX?

• No recent sales data due to withdrawal.
• Historical peak sales reached approximately USD 250 million annually before withdrawal.
• Reentry could face a multi-year approval process and substantial marketing costs.
• Competition dominance by newer agents limits revenue potential if reintroduced.

What are the key factors informing investment or R&D decisions?

• Safety profile improvements are critical for market reentry.
• Regulatory pathways remain complex, especially post-2010.
• The current landscape favors drugs with higher efficacy and lower adverse effects.
• Market size offers growth potential but limited unless safety concerns are addressed.

Key Takeaways

• AGGRENOX's market has been inactive since 2010, overshadowed by newer, safer obesity drugs.
• Regulatory barriers are high; reintroduction depends on safety profile enhancements.
• The anti-obesity market is expanding with innovative therapies, intensifying competition.
• Historical sales peaked at USD 250 million; future revenue prospects are uncertain without reformulation.
• Market entry would require significant investment, regulatory approval, and safety data.

FAQs

1. Can AGGRENOX be reintroduced to the market?
Yes, if it undergoes reformulation to mitigate safety concerns and obtains FDA approval, a reintroduction is possible but unlikely without substantial safety data.

2. What current drugs dominate the anti-obesity market?
Liraglutide (Saxenda), semaglutide (Wegovy), and phentermine/topiramate (Qsymia) are market leaders, with high efficacy and favorable safety profiles.

3. How do safety concerns impact AGGRENOX’s market potential?
Safety concerns led to its withdrawal. Without addressing these risks, regulatory agencies are unlikely to approve reentry.

4. What is the estimated market size for anti-obesity drugs in 2023?
Approximately USD 15 billion, with strong growth driven by rising obesity prevalence and approval of new therapies.

5. Are there legal liabilities associated with AGGRENOX?
Legal liabilities from past lawsuits exist, primarily related to cardiovascular side effects. Future liabilities depend on reapproval conditions and safety profile.

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References

[1] MarketWatch. (2022). Anti-obesity drugs market analysis.
[2] U.S. Food and Drug Administration. (2010). Black box warning on AGGRENOX.
[3] Grand View Research. (2022). Anti-obesity drugs market size and forecast.
[4] FDA. (2022). List of withdrawn or restricted drugs.
[5] IQVIA. (2023). Prescription data for obesity medications.