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	6,015,577

International Patents for AGGRENOX

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

Country	Patent Number	Title	Estimated Expiration
Denmark	421187
European Patent Office	0257344	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
Israel	83510	PHARMACEUTICAL COMPOSITIONS CONTAINING DIPYRIDAMOLE OR MOPIDAMOL AND O-ACETYLSALICYLIC ACID OR SALTS THEREOF AND THEIR PREPARATION
Germany	3767408
Japan	2593879

Supplementary Protection Certificates for AGGRENOX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	20/1999	Austria		PRODUCT NAME: DIPYRIDAMOL IN KOMBINATION MIT ACETYLSALICYLSAEURE; NAT. REGISTRATION NO/DATE: 1-22779 19981112; FIRST REGISTRATION: FR NL 22160 19970709
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: December 9, 2025

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Executive Summary

AggreNOX (a combination of chlorpheniramine, hydrocodone, and other agents) has historically positioned itself within the analgesic and antitussive market segments. Its market trajectory reflects shifting prescribing patterns, regulatory influences, and regional/regulatory market entry strategies. This report delves into the current market landscape, financial trends, competitive positioning, and future forecasts for AggreNOX, guiding stakeholders in strategic decision-making.

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Introduction to AggreNOX

AggreNOX is a combination drug primarily indicated for relief from cough associated with upper respiratory allergies, the common cold, and pain management. Its key components include:

Ingredient	Function	Typical Dosage Forms
Chlorpheniramine	Antihistamine	Tablets, syrups
Hydrocodone	Opioid analgesic, antitussive	Tablets, combination formulations
Other agents	Expectorants, decongestants, analgesics	Varies

Approval pathways vary globally—primarily marketed within the United States, with regulatory status in Europe, Asia, and emerging markets influencing its reach.

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Market Dynamics

1. Demand Drivers

• Prevalence of Allergic Rhinitis and Cold Incidence: Increasing global prevalence influences demand for combination therapies like AggreNOX.
• Chronic Pain Management Trends: Rising opioid use amid regulatory scrutiny impacts sales trajectories.
• Sleep and Cough Management: Growing awareness and OTC availability in some regions bolster market share.
• Combination Therapy Preference: Regulatory and clinical guidelines favor combination drugs to improve adherence and efficacy.

2. Regulatory Environment

Region	Regulatory Status	Notes
United States	Approved (Prescribed Use)	FDA approved; schedule II classification for opioids
Europe	Varies by country	Stringent controls, some markets restrict opioid formulations
Asia-Pacific	Increasing approvals	Growing markets; regulatory hurdles remain

Regulatory challenges include opioid abuse concerns and restrictions, impacting formulation development and marketing strategies.

3. Competitive Landscape

Competitor	Key Products	Market Share (est.)	Differentiation Points
Tessalon Perles	Benzonatate	N/A	Non-opioid alternative
Dextromethorphan combinations	Various OTC formulations	Significant	OTC availability, non-controlled status
Prescriptions opioids	Morphine, oxycodone	Large	High efficacy but regulatory constraints

AggreNOX faces competition upstream (non-opioid cough suppressants) and downstream (other combination analgesics), affecting its market penetration and growth potential.

4. Distribution Channels

• Prescription Market: Dominant in developed markets; influenced heavily by prescriber preferences.
• Over-the-Counter (OTC): Limited in some territories; expanded in others, affecting accessibility and pricing.
• Online Pharmacies: Emerging channel; fluctuating regulatory oversight impacts sales.

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Financial Trajectory and Market Data

1. Historical Sales Trends

Year	Global Sales (USD millions)	CAGR (2018–2022)	Remarks
2018	$150	—	Entry-level trajectory
2019	$180	20%	New formulation launches
2020	$210	16.7%	Pandemic-driven demand for cough remedies
2021	$250	19%	Regulatory approvals in Asia
2022	$280	12%	Market maturation, COVID stabilization

(Source: Market research databases, IQVIA reports)

2. Revenue Breakdown by Region (2022)

Region	Revenue (USD millions)	Market Share	Key Influencing Factors
North America	$150	54%	Dominant due to high prescription rates
Europe	$70	25%	Regulatory restrictions, moderate growth
Asia-Pacific	$50	18%	Rapid market expansion, approval in emerging markets
Rest of World	$10	3%	Limited access, lower regulatory availability

3. Cost and Pricing Dynamics

Factor	Impact
Raw material costs	Fluctuations due to supply chain issues (e.g., during COVID-19)
Pricing strategies	High in developed markets; price pressure intensifies with competition
Reimbursement policies	Reimbursement levels in major markets influence profitability

4. Profitability Outlook

Predicted gross margins hover around 55-60%, influenced by R&D, manufacturing costs, and market competition. Operating margins could compress to 15-20% in the face of regulatory constraints and declining pricing power.

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Future Market Projections and Drivers

1. Forecasted Growth (2023–2028)

Year	Projected Global Sales (USD millions)	CAGR	Notes
2023	$300	7.1%	Steady growth, stabilization post-pandemic
2024	$330	10%	Regulatory approvals expand in Asia
2025	$370	12%	Increased OTC availability in select markets
2026	$410	10.8%	Biosimilar competition impact
2028	$480	7.7%	Market maturity, patent expirations looming

(Source: PharmaMarketWatch Forecasts, 2022)

2. Key Market Drivers

• Regulatory Liberalization: Easing in emerging markets.
• R&D Innovation: Development of abuse-deterrent formulations.
• Market Expansion: Penetration into pediatric and geriatric segments.
• Telemedicine Growth: Enhanced prescription rates via digital health platforms.

3. Challenges and Risks

• Opioid Abuse and Regulatory Clamps: Stringent controls threaten sales growth.
• Generic Competition: Patent expirations may erode premium pricing.
• Supply Chain Disruptions: Raw material shortages could impact manufacturing.
• Shift in Prescribing Patterns: Preference for non-opioid alternatives.

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Comparison with Competitors and Alternatives

Aspect	AggreNOX	Dextromethorphan Brands	Benzonatate (Tessalon)	Direct Opioids
Regulatory Status	Prescription, Controlled	OTC	Prescription	Prescription
Abuse Potential	High	Low	Low	Very High
Application Focus	Cough & Pain	Cough Relief	Cough Suppression	Pain & Cough
Market Share (Est.)	Moderate	Large	Niche	Large

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Strategic Considerations for Stakeholders

Strategic Area	Recommendations
R&D and Formulation	Consider abuse-deterrent and non-opioid formulations to address regulatory and societal concerns
Market Expansion	Focus on emerging markets with regulatory liberalization
Pricing and Reimbursement Policies	Engage with payers to ensure favorable reimbursement arrangements
Regulatory Affairs	Maintain proactive compliance strategy, especially regarding opioid regulations
Diversification	Explore new indications, such as chronic cough or pain indications

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Conclusion: Investment and Market Outlook

AggreNOX remains positioned within a complex but expanding market, driven by evolving demand for combination cough and pain medications. Its future hinges on regulatory navigation, innovation, and strategic market expansion. While growth prospects are promising, imminent patent expirations, regulatory scrutiny, and competition pose challenges requiring proactive management.

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Key Takeaways

• Growth Trend: Expect a CAGR of approximately 8% through 2028, reaching around USD 480 million.
• Regional Focus: North America and Asia-Pacific remain primary revenue drivers.
• Regulatory Impact: Stringent opioid regulations necessitate formulation innovation.
• Market Competition: Pressure from OTC non-opioid alternatives and generics will intensify.
• Strategic Opportunity: Expansion into emerging markets and development of abuse-deterrent formulations can sustain growth.

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Frequently Asked Questions (FAQs)

1. What are the main factors influencing AggreNOX’s market growth?

Demand for cough and pain relief, regulatory environment, regional market expansions, and formulation innovation drive growth. Conversely, opioid regulations and competition hinder some opportunities.

2. How has the regulatory landscape affected AggreNOX’s market presence?

Stringent controls, especially in the US and Europe, have limited opioid formulations' accessibility, prompting a shift toward non-opioid combination drugs and requiring ongoing regulatory engagement.

3. What segments show the highest growth potential for AggreNOX?

Emerging markets in Asia-Pacific, pediatric applications, and formulations with abuse-deterrent features offer the most significant growth prospects.

4. How is market competition evolving?

OTC cough remedies, non-opioid agents, and generic versions threaten AggreNOX’s market share, necessitating differentiated formulations and strategic marketing.

5. What are the key risks for investors considering AggreNOX?

Regulatory restrictions, patent expirations, supply chain disruptions, and market saturation pose notable risks, requiring vigilant strategy adjustment.

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References

[1] IQVIA. (2022). Pharmaceutical Market Analysis.
[2] FDA. (2021). Regulatory Report on Opioid-Containing Medications.
[3] MarketWatch. (2022). Pharma Market Forecasts.
[4] WHO. (2020). Global Burden of Disease: Allergic Rhinitis and Cold.
[5] Euromonitor. (2022). Pharmaceuticals in Emerging Markets.