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. Eleven 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:	6
Clinical Trials:	16
Patent Applications:	52
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
Canada	1302272	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU DIPYRIDAMOLE OU DU MOPIDAMOI OU DE L'ACIDE O-ACETYLSALYCYLIQUE OU DES SELS PHYSIOLOGIQUEMENT ACCEPTABLES DE CEUX-CI, PROCEDE POUR LEUR PREPARATION ET LEUR UTILISATION POUR LE TRAITEMENT DE FORMATION DE CAILLOTS (PHARMACEUTICAL COMPOSITIONS CONTAINING DIPYRIDAMOLE OR MOPIDAMOL AND O-ACETYLSALICYLIC ACID OR THE PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF, PROCESSES FOR PREPARING THEM AND THEIR USE IN TREATING CLOT FORMATION)
Finland	873492
Germany	10299015
Germany	3627423
Greece	3001695

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	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
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

Market Dynamics and Financial Trajectory for AGGRENOX

Introduction

AGGRENOX, a combination of aspirin and extended-release dipyridamole, is a crucial medication for reducing the risk of stroke in patients who have experienced a transient ischemic attack (TIA) or stroke due to a blood clot. Here, we delve into the market dynamics and financial trajectory of AGGRENOX.

Market Need and Patient Base

The demand for AGGRENOX is driven by the significant number of patients at risk of stroke. According to the National Institutes of Health, approximately 185,000 Americans are at risk of another stroke within five years of a previous stroke[1].

Original Product and Patent Expiry

AGGRENOX was originally marketed by Boehringer Ingelheim, and its patent expiry opened the door for generic versions. The original product had substantial market presence, with annual sales of approximately $457 million in the United States before the launch of generic versions[1].

Generic Launch and Market Impact

In 2015, Teva Pharmaceutical Industries launched a generic version of AGGRENOX in the United States. This launch significantly impacted the market by providing a more affordable alternative to the branded product. Teva's commitment to making high-quality generic medicines available highlights the company's strategy to capture a substantial share of the market[1].

Competitive Landscape

The introduction of generic versions of AGGRENOX has intensified competition in the antiplatelet agent market. Other pharmaceutical companies may also enter the market with their own generic or branded products, further increasing competition. This competitive environment can lead to pricing pressures and affect the financial trajectory of the drug[1].

Pricing Dynamics

The launch of generic AGGRENOX led to a reduction in prices, making the medication more accessible to a wider patient base. However, this also resulted in reduced revenue for the original branded product. The pricing dynamics are influenced by governmental pricing pressures, competition from other generic manufacturers, and the overall market demand[1].

Clinical Efficacy and Safety

The efficacy and safety of AGGRENOX have been well-documented in clinical trials such as the ESPS2 study. This study compared AGGRENOX with placebo, extended-release dipyridamole alone, and aspirin alone, demonstrating its effectiveness in reducing the risk of stroke. However, the study also highlighted adverse events, which can impact patient compliance and market acceptance[4].

Adverse Events and Patient Compliance

The ESPS2 study showed that AGGRENOX had a discontinuation rate due to adverse events of 25%, similar to extended-release dipyridamole but higher than aspirin alone. This highlights the need for careful patient monitoring and management of side effects to maintain compliance and market share[4].

Financial Performance of Generic Versions

The financial performance of generic AGGRENOX is closely tied to the volume of sales and pricing. Teva's launch of the generic version was expected to capture a significant market share due to its lower price point. The annual sales of approximately $457 million for the branded product before the generic launch indicate the potential revenue that generic manufacturers can target[1].

Impact on Pharmaceutical Companies

For companies like Teva, the launch of generic AGGRENOX is part of a broader strategy to expand their generic product portfolio. This helps in diversifying revenue streams and mitigating risks associated with patent expiries and competitive pressures in the specialty pharmaceutical segment[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of AGGRENOX. Generic manufacturers must comply with stringent FDA regulations to ensure the quality and efficacy of their products. Any changes in regulatory requirements or patent laws can significantly impact the market and financial trajectory of the drug[1].

Market Access and Reimbursement

Market access and reimbursement are critical factors influencing the adoption of AGGRENOX. Generic manufacturers often engage in payor engagement strategies to secure formulary coverage, which can significantly affect the drug's market penetration and revenue[3].

Conclusion

The market dynamics and financial trajectory of AGGRENOX are shaped by several key factors, including the launch of generic versions, competitive landscape, pricing dynamics, clinical efficacy, and regulatory environment. Here are some key takeaways:

• Market Need: High demand driven by patients at risk of stroke.
• Generic Competition: Significant impact from generic launches, leading to pricing pressures.
• Clinical Efficacy: Proven effectiveness in reducing stroke risk, but with notable adverse events.
• Financial Performance: Tied to sales volume and pricing, with potential for substantial revenue.
• Regulatory Environment: Compliance with FDA regulations crucial for market presence.
• Market Access: Formulary coverage and reimbursement strategies critical for adoption.

Key Takeaways

• The launch of generic AGGRENOX has significantly impacted the market by offering a more affordable alternative.
• The drug's efficacy and safety profile, as demonstrated in clinical trials, are crucial for its market acceptance.
• Regulatory compliance and market access strategies are vital for maintaining market share.
• The financial performance of generic AGGRENOX is influenced by sales volume, pricing, and competitive dynamics.

FAQs

Q: What is AGGRENOX used for? A: AGGRENOX is used to reduce the risk of stroke in patients who have had a transient ischemic attack (TIA) or stroke due to a blood clot.

Q: Who launched the generic version of AGGRENOX in the United States? A: Teva Pharmaceutical Industries launched the generic version of AGGRENOX in the United States in 2015.

Q: What was the annual sales figure for AGGRENOX before the generic launch? A: The annual sales for AGGRENOX before the generic launch were approximately $457 million in the United States.

Q: What are the common adverse events associated with AGGRENOX? A: Common adverse events include hemorrhage, central and peripheral nervous system disorders, and other side effects that led to a discontinuation rate of 25% in clinical trials.

Q: How does the regulatory environment impact the market dynamics of AGGRENOX? A: The regulatory environment, including FDA regulations and patent laws, significantly influences the market presence and financial trajectory of AGGRENOX by ensuring compliance and affecting the ability to manufacture and market the drug.

Sources

1. Teva Pharmaceutical Industries Ltd. - "Teva Launches Generic Aggrenox® Capsules in the United States"[1]
2. argenx SE - "argenx Reports Half Year 2024 Financial Results and Provides Second Quarter Business Update"[2]
3. Agile Therapeutics, Inc. - "Agile Therapeutics Reports Fourth Quarter & Full Year 2020 Financial Results; Expands Loan Facility With Perceptive Advisors"[3]
4. Drugs.com - "Aggrenox: Package Insert / Prescribing Information"[4]
5. argenx SE - "argenx Reports Full Year 2023 Financial Results and Provides Fourth Quarter Business Update"[5]