Aspirin; omeprazole - Generic Drug Details

What are the generic sources for aspirin; omeprazole and what is the scope of freedom to operate?

Aspirin; omeprazole is the generic ingredient in one branded drug marketed by Genus Lifesciences and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Aspirin; omeprazole has nine patent family members in eight countries.

Summary for aspirin; omeprazole

International Patents:	9
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	14
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aspirin; omeprazole
DailyMed Link:	aspirin; omeprazole at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for aspirin; omeprazole

Dosage:

TABLET, DELAYED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for aspirin; omeprazole

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

Sponsor	Phase
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4
Yaling Han	Phase 4

See all aspirin; omeprazole clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for aspirin; omeprazole

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for ASPIRIN; OMEPRAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
YOSPRALA	Delayed-release Tablets	aspirin; omeprazole	81 mg/40 mg and 325 mg/40 mg	205103	1	2016-10-17
YOSPRALA	Delayed-release Tablets	aspirin; omeprazole	81 mg/40 mg and 325 mg/40 mg	205103	1	2016-10-14

US Patents and Regulatory Information for aspirin; omeprazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016		DISCN	Yes	No
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016		DISCN	Yes	No
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016		DISCN	Yes	No
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016		DISCN	Yes	No

Expired US Patents for aspirin; omeprazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016

International Patents for aspirin; omeprazole

Country	Patent Number	Title	Estimated Expiration
China	104519888	Improved compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Eurasian Patent Organization	028049	УЛУЧШЕННЫЕ КОМПОЗИЦИИ И СПОСОБЫ ДОСТАВКИ ОМЕПРАЗОЛА И АЦЕТИЛСАЛИЦИЛОВОЙ КИСЛОТЫ (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID)
Brazil	112014016085	composições aprimoradas e métodos para distribuição de omeprazol mais ácido acetilsalicílico
European Patent Office	2797600	COMPOSITIONS ET PROCÉDÉS D'ADMINISTRATION D'OMÉPRAZOLE PLUS ACIDE ACÉTYLSALICYLIQUE AMÉLIORÉS (IMPROVED COMPOSITIONS AND METHODS FOR DELIVERY OF OMEPRAZOLE PLUS ACETYLSALICYLIC ACID)

Aspirin; omeprazole Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aspirin and Omeprazole

Introduction to Aspirin and Omeprazole

Aspirin and omeprazole are two widely used medications with distinct therapeutic applications. Aspirin, a nonsteroidal anti-inflammatory drug (NSAID), is primarily used for pain relief, reducing inflammation, and preventing cardiovascular diseases. Omeprazole, a proton pump inhibitor (PPI), is used to treat conditions such as gastroesophageal reflux disease (GERD), ulcers, and other disorders caused by excessive stomach acid.

Aspirin Market Dynamics

Current Market Trends

In the third quarter of 2024, the aspirin market exhibited a significant upward trend globally. In Asia, prices increased due to robust demand and tightening supply conditions, particularly driven by the pharmaceutical sector in China[1].

• Supply Chain Disruptions: European aspirin prices also rose due to strong market fundamentals and supply chain disruptions. Despite high logistics costs, sellers managed to implement price hikes[1].
• North America: The US market saw steady price appreciation driven by rising production costs and stable demand from end-user industries. Mid-quarter price increases were accelerated by supply chain bottlenecks and raw material cost surges[1].

Future Outlook

• Growth Projections: The global aspirin market is expected to grow from $2.938 billion in 2024 to $4.236 billion by 2034, at a compound annual growth rate (CAGR) of 3.8%[4].
• Driving Factors: The surge in cardiovascular diseases, fueled by lifestyle factors such as high-cholesterol diets and smoking, is a key driver of this growth. Aspirin's effectiveness in preventing heart attacks and strokes contributes significantly to its market demand[4].

Market Segments

• Combination Aspirins: The combination segment is predicted to hold a significant market share, around 68.0% in 2024, driven by increasing cases of strokes and other cardiovascular events[4].
• Tablets and Capsules: Tablets are expected to lead in terms of indication, with a projected market share of around 44.8% by 2024, due to their widespread use for conditions like arthritis, pain, and swelling[4].

Omeprazole Market Dynamics

Current Market Trends

The omeprazole market has been growing steadily, driven by increasing cases of chronic diseases globally.

• Market Size: The omeprazole market size was valued at $2.17 billion in 2023 and is expected to grow to $2.34 billion in 2024, with a CAGR of 7.6%[2].
• Regional Performance: The North American market holds the largest share, with a prevalence of H. pylori infections and peptic ulcers contributing to the demand for omeprazole[5].

Future Outlook

• Growth Projections: The omeprazole market is expected to cross $2.38 billion by 2036, expanding at a CAGR of more than 6.4% during the forecast period[5].
• Driving Factors: Positive results from clinical trials, such as those for H. pylori elimination therapy, and the increasing incidence of chronic diseases like cancer, diabetes, and respiratory ailments are key drivers of this growth[5].

Market Segments

• Dosage Forms: The capsule segment is expected to propel the omeprazole market growth, occupying around 52% of the market share by 2036. Tablets, being easy to handle and inexpensive, also contribute significantly to the market[5].
• Indications: The market is driven by various indications including duodenal ulcers, gastric ulcers, gastroesophageal reflux, and erosive esophagitis. The prevalence of these conditions, particularly in the US, supports the market growth[5].

Financial Trajectory

Aspirin

• Revenue Forecast: The global aspirin drug market is projected to rise from $2.938 billion in 2024 to $4.236 billion by 2034, indicating a consistent growth trajectory[4].
• CAGR: The market is expected to grow at a CAGR of 3.8% over the next decade, driven by the increasing demand for aspirin in preventing cardiovascular diseases[4].

Omeprazole

• Revenue Forecast: The omeprazole market is expected to grow from $2.17 billion in 2023 to $2.34 billion in 2024 and further to $3.15 billion by 2028, with a CAGR of 7.7%[2].
• Long-Term Growth: By 2036, the market is projected to cross $2.38 billion, expanding at a CAGR of more than 6.4% during the forecast period[5].

Key Drivers and Challenges

Aspirin

• Key Drivers: Rising cases of cardiovascular diseases, lifestyle factors, and the effectiveness of aspirin in preventing heart attacks and strokes are major drivers[4].
• Challenges: Supply chain disruptions, high logistics costs, and geopolitical tensions affecting supply chains are significant challenges[1].

Omeprazole

• Key Drivers: Increasing cases of chronic diseases, positive clinical trial results, and the prevalence of conditions like GERD and peptic ulcers are key drivers[5].
• Challenges: Economic inflation, freight costs, and fluctuations in global trading sentiments can impact market stability[1].

Strategic Moves by Manufacturers

Aspirin

• New Formulations: Pharmaceutical manufacturers are focusing on new drug discoveries and the formulation of effective tablets and capsules. Educational campaigns and expanding online presence are also strategic moves to stay relevant[4].
• Combination Products: The development of combination aspirin products is a significant strategy, given their high market share and demand[4].

Omeprazole

• Clinical Trials: Positive results from clinical trials, such as those for H. pylori elimination therapy, are driving innovation and demand. Manufacturers like RedHill Biopharma are investing in such research[5].
• Dosage Forms: The development of capsules and tablets that are easy to handle and inexpensive is a key strategy to capture market share[5].

Key Takeaways

• Aspirin Market: Expected to grow from $2.938 billion in 2024 to $4.236 billion by 2034, driven by rising cardiovascular diseases and lifestyle factors.
• Omeprazole Market: Expected to grow from $2.17 billion in 2023 to $2.38 billion by 2036, driven by increasing chronic diseases and positive clinical trial results.
• Market Segments: Combination aspirins and omeprazole capsules are expected to lead their respective markets.
• Regional Performance: North America and Asia are significant regions for both aspirin and omeprazole markets.

FAQs

What are the primary drivers of the aspirin market growth?

The primary drivers include rising cases of cardiovascular diseases, lifestyle factors such as high-cholesterol diets and smoking, and the effectiveness of aspirin in preventing heart attacks and strokes[4].

How is the omeprazole market expected to grow in the coming years?

The omeprazole market is expected to grow from $2.17 billion in 2023 to $2.38 billion by 2036, expanding at a CAGR of more than 6.4% during the forecast period[5].

What are the key challenges facing the aspirin market?

Supply chain disruptions, high logistics costs, and geopolitical tensions affecting supply chains are significant challenges for the aspirin market[1].

Which dosage form is expected to lead the omeprazole market?

The capsule segment is expected to propel the omeprazole market growth, occupying around 52% of the market share by 2036[5].

How does the combination segment contribute to the aspirin market?

The combination segment is predicted to hold a significant market share, around 68.0% in 2024, driven by increasing cases of strokes and other cardiovascular events[4].

Sources

1. Procurement Resource: Aspirin Price Trend, Index, News, Chart, Database.
2. OpenPR: Omeprazole Market Size, Share, Growth, Trends And Forecast.
3. Verified Market Research: In-Depth Industry Outlook: Aspirin Market Size & Forecast.
4. PR Newswire: Aspirin Drug Market to Soar to US$4.2 Billion by 2034, Driven by Combination Aspirins' Dominance.
5. Research Nester: Omeprazole Market Size & Share | Growth Forecasts 2036.