Physiological Effect: Increased Large Intestinal Motility

Drugs with Physiological Effect: Increased Large Intestinal Motility

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	SOLUTION;INJECTION	088911-002	May 17, 1985	AP	RX	No	No
Fresenius Kabi Usa	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	SOLUTION;INJECTION	088911-001	Feb 7, 1985	AP	RX	No	No
Hospira	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	SOLUTION;INJECTION	018800-002	Oct 29, 1982	AP	RX	Yes	Yes
Hospira	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	SOLUTION;INJECTION	018800-003	Oct 29, 1982	AP	RX	Yes	Yes
Hospira	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	SOLUTION;INJECTION	018800-001	Oct 29, 1982	AP	RX	Yes	Yes

Increased Large Intestinal Motility Market Analysis and Financial Projection

The market for drugs enhancing large intestinal motility is experiencing significant growth and innovation, driven by rising gastrointestinal disorder prevalence and advancements in drug development. Here's an analysis of the market dynamics and patent landscape:

Market Growth and Drivers

• Projected Expansion: The global gastric motility disorder drugs market is expected to grow from $54.7 billion in 2024 to $90.41 billion by 2033, at a 5% CAGR[1]. This includes drugs targeting conditions like gastroparesis, irritable bowel syndrome (IBS), and chronic constipation.
• Key Segments: Prokinetic agents (e.g., metoclopramide, domperidone) dominate due to their efficacy in accelerating gastric emptying and alleviating symptoms like nausea and bloating[1][12]. The laxative market, closely related to intestinal motility, is also expanding, projected to reach $12.7 billion by 2033 (6.01% CAGR)[4].
• Regional Trends:
  • North America leads with ~40% market share, driven by high disorder prevalence, strong R&D investment, and regulatory support[1][10].
  • Asia-Pacific is the fastest-growing region (6.3% CAGR), fueled by urbanization, dietary changes, and improving healthcare access[10][14].

Innovation and Patent Landscape

1. Novel Drug Delivery Systems:

   • Evoke Pharma: Secured patents for GIMOTI (intranasal metoclopramide), addressing absorption challenges in gastroparesis patients. Patents expire in 2029, with no competing intranasal products in development[2][12].
   • Renexxion Ireland: Patented naronapride, a dual-action prokinetic (5HT4 agonist and D2 antagonist), with exclusivity until 2038. It targets gastroparesis, IBS-C, and chronic idiopathic constipation (CIC)[13].

2. New Drug Classes:

   • Macrocyclic Ghrelin Receptor Modulators: Patented compounds (e.g., AU2015201862A1) show promise for post-operative ileus and diabetic gastroparesis by mimicking ghrelin’s motility-enhancing effects[15].
   • 9-Desoxoerythromycin Derivatives: Patent WO2005060693A2 highlights erythromycin analogs as prokinetic agents for upper and lower GI disorders[8].

3. Collaborative R&D:

   • Solvay Pharmaceuticals and Mayo Clinic are investigating novel motility mechanisms, potentially leading to new therapies[7].
   • Vanda Pharmaceuticals and Processa Pharmaceuticals have initiated clinical trials for tradipitant and PCS12852, respectively, targeting gastroparesis[1].

Challenges and Opportunities

• Absorption Issues: Delayed gastric emptying compromises oral drug efficacy, prompting non-oral formulations (e.g., nasal sprays, injections)[2][1].
• Personalized Medicine: Emerging trends include genomics-driven therapies and combination treatments (e.g., prokinetics with laxatives or antiemetics) to improve efficacy[14].
• Regulatory and Competitive Pressures: Patent expirations (e.g., generics for metoclopramide) are offset by new patents for improved formulations and mechanisms[2][13].

Key Players and Strategies

• Major Companies: Pfizer, Eisai, Mallinckrodt, and Evoke Pharma lead with established prokinetics[1][2].
• Strategic Moves: Focus on geographic expansion (e.g., Asia-Pacific), combination therapies, and real-world data to demonstrate drug efficacy[10][14].

Future Outlook

The market will likely see increased adoption of non-oral therapies and targeted agents (e.g., serotonin/dopamine modulators) to address unmet needs in motility disorders. Patent activity emphasizes novel mechanisms and extended exclusivity, ensuring sustained growth amidst rising global demand.

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"GIMOTI remains the only FDA-approved metoclopramide nasal spray, offering a novel solution for patients... these patents reinforce GIMOTI’s uniqueness."
— Matt D’Onofrio, CEO of Evoke Pharma[2]

This evolving landscape underscores the critical role of innovation in addressing complex gastrointestinal motility challenges.

References

1. https://www.datamintelligence.com/research-report/gastric-motility-disorder-drugs-market
2. https://www.biospace.com/press-releases/evoke-pharma-receives-notices-of-allowance-for-two-additional-us-patent-applications-protecting-gimoti
3. https://patents.google.com/patent/US20030176421A1/en
4. https://www.marketdataforecast.com/market-reports/laxative-market
5. https://en.wikipedia.org/wiki/Metformin
6. https://www.precedenceresearch.com/gastric-motility-disorder-drug-market
7. https://www.drugdiscoverynews.com/solvay-mayo-tackle-gi-motility-disorders-385
8. https://patents.google.com/patent/WO2005060693A2/en
9. https://eureka.patsnap.com/patent-US6944316B2
10. https://www.cognitivemarketresearch.com/prokinetic-drug-market-report
11. https://pmc.ncbi.nlm.nih.gov/articles/PMC5491688/
12. https://pubmed.ncbi.nlm.nih.gov/8348856/
13. https://www.rnexltd.ie/renexxion-ireland-announces-issuance-of-a-new-us-patent-covering-naronapride-a-clinical-stage-potential-best-in-class-prokinetic-agent-for-gastrointestinal-disorders.html
14. https://www.theinsightpartners.com/reports/prokinetic-drugs-market
15. https://patents.google.com/patent/AU2015201862A1/en