Drugs in MeSH Category Anti-Ulcer Agents

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	CIMETIDINE	cimetidine	TABLET;ORAL	074463-001	May 17, 1994	AB	RX	No	No
Sandoz	CIMETIDINE	cimetidine	TABLET;ORAL	075122-002	Jun 19, 1998		DISCN	No	No
Ivax Sub Teva Pharms	CIMETIDINE	cimetidine	TABLET;ORAL	074424-003	Jul 28, 1995		DISCN	No	No
Perrigo R And D	FAMOTIDINE	famotidine	TABLET;ORAL	077351-001	Sep 25, 2006		OTC	No	No
Takeda Pharms Usa	DEXILANT	dexlansoprazole	CAPSULE, DELAYED RELEASE;ORAL	022287-002	Jan 30, 2009	AB	RX	Yes	Yes					Y
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Anti-Ulcer Agents Market Analysis and Financial Projection

The global anti-ulcer drug market is undergoing significant transformation, driven by therapeutic advancements and evolving patent dynamics. Here's a comprehensive analysis of current trends and future trajectories:

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Market Dynamics

Growth Drivers

• Prevalence Surge: The market (valued at $42.6B in 2025 [5]) is propelled by rising gastrointestinal disorders, stress-related ulcers, and an aging population, with a projected 4.9–9.3% CAGR through 2032 [1][15]. Proton pump inhibitors (PPIs) and H2-receptor antagonists dominate due to efficacy in acid suppression [1][14].
• Innovative Therapies: Pipeline drugs like Takeda’s Vonoprazan fumarate (P-CAB class, Phase III) [3] and combo therapies (e.g., Talicia for H. pylori [3]) are reshaping treatment protocols.

• Regional Shifts:	Region	Market Share (2025)	Key Factors
  North America	30% [1]	High NSAID usage, advanced healthcare
  Asia-Pacific	20% [1]	Rising healthcare access, urbanization
  Europe	25% [1]	Strong generics sector, regulatory frameworks

Challenges

• Side Effects: Long-term PPI use links to magnesium deficiency and increased infection risks [3][14].
• Cost Pressures: Patent expirations (e.g., Prevacid generics) intensify price competition [6].

Key Players: AstraZeneca (PPIs), Pfizer, and Takeda lead innovation, with AstraZeneca’s gastroenterology segment contributing to its $37B revenue [1]. Emerging markets see local manufacturers gaining traction through cost-effective generics [7].

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Patent Landscape

Innovation Trends

• Novel Compounds: Recent patents include quassinoid derivatives (EP0206112A1 [2]) and H. pylori-targeting formulations (King Saud University’s USPTO 8933267 [8]).
• Combination Therapies: 65% of new patents focus on antibiotic-PPI combos to enhance H. pylori eradication [10].

Secondary Patent Dominance

• Anti-ulcer drugs exhibit a 1:4 primary-to-secondary patent ratio [11], extending monopolies through formulation tweaks (e.g., extended-release PPIs) and delivery methods.

2025 Patent Cliffs	Drug	Company	Impact
Stelara	Johnson & Johnson	Biosimilars to cut Crohn’s treatment costs [13]
Jardiance	Boehringer Ingelheim	Generic SGLT2 inhibitors challenge diabetes market [13]

Litigation Risks: Non-steroidal anti-inflammatory drug (NSAID) formulations face challenges as 28% of patents target NSAID-induced ulcer prevention [12].

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Future Outlook

• Personalized Medicine: CRISPR-based H. pylori detection and microbiome modulators are under exploration [15].
• Biosimilar Surge: Post-2025, biosimilars for biologics like Stelara will reduce treatment costs by ~40% [13].
• Digital Integration: AI-driven adherence tools (e.g., smart pillboxes) aim to address poor compliance in chronic ulcer management [1].

"The shift toward combo therapies and secondary patents reflects industry efforts to balance innovation with lifecycle management." – Market Analysis [1][11].

As generics and biosimilars gain ground, manufacturers must prioritize R&D in underserved areas (e.g., pediatric formulations) and emerging markets to sustain growth. Regulatory focus on drug safety (e.g., FDA’s 2024 PPI labeling mandates [14]) will further shape market entry strategies.

References

1. https://github.com/zdybelzinn/Market-Research-Report-List-1/blob/main/anti-ulcer-drug-market.md
2. https://patents.google.com/patent/EP0206112A1/en
3. https://www.fortunebusinessinsights.com/peptic-ulcer-drugs-market-103483
4. https://meshb.nlm.nih.gov/record/ui?ui=D000897
5. https://www.persistencemarketresearch.com/market-research/peptic-ulcer-drugs-market.asp
6. https://aem-prod.oklahoma.gov/content/dam/ok/en/okhca/docs/about/boards-and-committees/dur/2024/june/06122024%20DUR%20Packet.pdf
7. https://www.datamintelligence.com/research-report/antiulcerant-drugs-market
8. https://patents.justia.com/patent/8933267
9. https://pharsight.greyb.com/collections/drugs-opening-to-patent-challenges-in-2025
10. https://pmc.ncbi.nlm.nih.gov/articles/PMC11086278/
11. https://journals.plos.org/plosone/article?id=info%3Adoi%2F10.1371%2Fjournal.pone.0124257
12. https://pubmed.ncbi.nlm.nih.gov/33843400/
13. https://biopharmaapac.com/analysis/60/5727/25-high-value-drugs-losing-patent-protection-in-2025-what-it-means-for-healthcare.html
14. https://pmc.ncbi.nlm.nih.gov/articles/PMC10538946/
15. https://datahorizzonresearch.com/anti-peptic-ulcer-drugs-market-4408

Last updated: 2025-03-27