Physiological Effect: Stimulation Large Intestine Fluid/Electrolyte Secretion

Drugs with Physiological Effect: Stimulation Large Intestine Fluid/Electrolyte Secretion

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	TIS-U-SOL	magnesium sulfate; potassium chloride; potassium phosphate, monobasic; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	018508-001	Feb 19, 1982	AT	RX	No	No
Braintree Labs	SUTAB	magnesium sulfate; potassium chloride; sodium sulfate	TABLET;ORAL	213135-001	Nov 10, 2020		RX	Yes	Yes	11,382,864
Braintree Labs	SUTAB	magnesium sulfate; potassium chloride; sodium sulfate	TABLET;ORAL	213135-001	Nov 10, 2020		RX	Yes	Yes	11,033,498
Braintree Labs	SUTAB	magnesium sulfate; potassium chloride; sodium sulfate	TABLET;ORAL	213135-001	Nov 10, 2020		RX	Yes	Yes	11,638,697		Y
Hospira	TPN ELECTROLYTES IN PLASTIC CONTAINER	calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride	INJECTABLE;INJECTION	018895-001	Jul 20, 1984		RX	Yes	Yes

Stimulation Large Intestine Fluid/Electrolyte Secretion Market Analysis and Financial Projection

The market for drugs stimulating large intestine fluid/electrolyte secretion is shaped by growing gastrointestinal disorder prevalence, expanding biologic therapies, and evolving patent landscapes. This sector includes laxatives, chloride channel activators, and targeted biologics addressing conditions like chronic constipation and IBS-C. Below is a structured analysis:

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Market Dynamics

1. Market Size & Growth

   • The global gastrointestinal therapeutics market reached $37.6 billion in 2022, projected to grow at 3.3% CAGR through 2030[1].
   • Digestive remedies specifically were valued at $21.5 billion in 2024, with 4.25% CAGR expected through 2030[10].

2. Key Growth Drivers

   • Rising prevalence of disorders (IBS, Crohn’s, ulcerative colitis)[1][7].
   • FDA approvals for novel biologics (e.g., AbbVie’s RINVOQ for ulcerative colitis, SKYRIZI for Crohn’s)[1].
   • Shift toward cost-effective generics and biosimilars (e.g., polyethylene glycol 3350 with tentative generic approvals)[2][7].

3. Dominant Drug Classes

   • Biologics/biosimilars: Held 44% market share in 2022, driven by drugs like adalimumab and infliximab[1].
   • Osmotic laxatives: Polyethylene glycol 3350 is widely used, with ongoing Phase 4 trials for efficacy optimization[2][12].
   • Prosecretory agents: Lubiprostone (Amitiza) and linaclotide stimulate chloride channels to enhance fluid secretion[5][12].

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Patent Landscape

Key Patents and Innovations

Drug/Mechanism	Patent Focus	Status/Expiry Insights
Lubiprostone	Synthesis processes (US8846958B2)[15]	Multiple patents expired (2021–2025), enabling generics[18].
GC-C receptor agonists	Peptide-based therapies (US7304036B2)[8]	Covers linaclotide analogs for chronic constipation.
Combination laxatives	Osmotic + bulk-forming agents (US5651988A)[14]	Expired, facilitating generic combinations.

Emerging Trends

• Generics/Biosimilars: Tentative FDA approvals for polyethylene glycol 3350 generics indicate looming competition[2].
• Novel Targets: Patents targeting CFTR and calcium-activated chloride channels (CaCCs) for constipation[5][12].
• Formulation Advances: Microencapsulation technologies for sustained-release biologics[6][7].

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Competitive Landscape

• Leading Companies: AbbVie, Takeda, Sanofi, and Pfizer dominate with branded biologics[1][10].
• Recent Approvals:
  • VOQUEZNA (vonoprazan): Approved in 2024 for GERD[10].
  • RINVOQ: Expanded indicatiosn for ulcerative colitis (2022)[1].

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Challenges and Opportunities

• Regulatory Hurdles: Stringent requirements for biologic approvals[1][7].
• R&D Opportunities:
  • Molecular dynamics: Simulating drug-biomolecule interactions to optimize absorption[6].
  • Personalized therapies: Probiotics targeting immune modulation (e.g., IgA secretion enhancement)[9].

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Future Outlook

The sector will see increased generic penetration post-patent expirations (e.g., lubiprostone)[17][18], while biologic pipelines (e.g., ustekinumab, risankizumab) drive innovation[1][7]. Advances in chloride channel modulators and combo therapies (osmotic + bulk laxatives)[11][14] will address unmet needs in severe constipation and IBS-C.

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"The ability to therapeutically activate Cl⁻ secretion is increasingly recognized as an effective strategy in many forms of constipation."[12]

This blend of scientific innovation and market competition positions the sector for sustained growth, with a projected $62.96 billion valuation by 2031[7].

References

1. https://www.grandviewresearch.com/industry-analysis/gastrointestinal-therapeutics-market
2. https://www.drugpatentwatch.com/p/generic/polyethylene+glycol+3350
3. https://patents.google.com/patent/US8314066B2/en
4. https://www.cognitivemarketresearch.com/lubiprostone-market-report
5. https://pmc.ncbi.nlm.nih.gov/articles/PMC5491688/
6. https://strathprints.strath.ac.uk/80019/1/Wilson_etal_EJPS_2022_Integration_of_advanced_methods_and_models_to_study_drug_absorption_and_related_processes.pdf
7. https://www.marketsandata.com/industry-reports/gastrointestinal-drugs-market
8. https://patents.google.com/patent/US7304036B2/en
9. https://www.epo.org/en/boards-of-appeal/decisions/t161340eu1
10. https://www.grandviewresearch.com/industry-analysis/digestives-intestinal-remedies-market-report
11. https://patents.google.com/patent/AU6661396A/fr
12. https://pmc.ncbi.nlm.nih.gov/articles/PMC8917926/
13. https://patents.google.com/patent/US20120219642A1/en
14. https://patents.google.com/patent/US5651988A/en
15. https://patents.google.com/patent/US8846958B2/en
16. https://patents.google.com/patent/WO2012048447A1/en
17. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209450Orig1s000TA_ltr.pdf
18. https://www.drugpatentwatch.com/p/tradename/AMITIZA