Physiological Effect: Inhibition Large Intestine Fluid/Electrolyte Absorption

Drugs with Physiological Effect: Inhibition Large Intestine Fluid/Electrolyte Absorption

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	11,638,697		Y
Braintree Labs	SUTAB	magnesium sulfate; potassium chloride; sodium sulfate	TABLET;ORAL	213135-001	Nov 10, 2020		RX	Yes	Yes	10,143,656		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
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009		OTC	Yes	Yes

Inhibition Large Intestine Fluid/Electrolyte Absorption Market Analysis and Financial Projection

The market dynamics and patent landscape for drugs inhibiting large intestine fluid/electrolyte absorption reflect a growing focus on addressing chronic gastrointestinal and metabolic disorders through targeted pharmacological mechanisms. Here's a structured analysis:

---

Key Drug Targets and Mechanisms

• NHE3 Inhibition: Tenapanor (developed by Ardelyx) blocks sodium/hydrogen exchanger isoform 3 (NHE3), reducing sodium and phosphate absorption. This increases luminal sodium retention, drawing water into the intestines to alleviate constipation[16][17].
• SLC26A3 Inhibition: Drugs like DRA inh-A270 target the chloride/bicarbonate exchanger SLC26A3, inhibiting colonic fluid absorption and normalizing stool hydration[10][15].
• Combination Therapies: Co-administration of NHE3 and SLC26A3 inhibitors has shown synergistic efficacy in reversing constipation, suggesting a strategic shift toward multi-target approaches[15].

---

Market Landscape and Key Players

• Leading Drugs:

  • Tenapanor: Approved for irritable bowel syndrome with constipation (IBS-C) and hyperphosphatemia in chronic kidney disease (CKD). Market size is projected to grow with a CAGR of ~% through 2031, driven by North America and Europe[17][19].
  • Plecanatide/Linaclotide: Guanylate cyclase-C agonists that increase intestinal fluid secretion, though diarrhea remains a common side effect[7].

• Major Companies:

  • Ardelyx: Holds key patents for Tenapanor (e.g., US12016856B2) and collaborates with AstraZeneca for global licensing[18][20].
  • Fosun Pharma/Kyowa Kirin: Expanding regional market reach in Asia-Pacific[19].

---

Patent Trends and Innovations

• Strategic IP Protection:
  • Tenapanor’s patents (e.g., US10940146) are active until 2034, with exclusivities extending to 2026, delaying generic competition[20].
  • Rising patents for resistant starch (e.g., dietary fiber innovations by Tate & Lyle, Cargill) and reformulation technologies (e.g., satiety-enhancing agents) intersect with gastrointestinal health[9][14].
• Emerging Targets: Small-molecule inhibitors of SLC26A3 and NHE3 dominate recent filings, reflecting a shift toward locally acting, minimally absorbed therapies[10][16].

---

Regional Dynamics

• North America/Europe: Lead adoption due to advanced healthcare infrastructure and high prevalence of IBS-C/CKD. Tenapanor’s Phase III trials and partnerships (e.g., Ardelyx-AstraZeneca) reinforce dominance[17][18].
• Asia-Pacific: Rapid growth driven by increasing CKD cases and healthcare investments. Fosun Pharma and Kyowa Kirin are key contributors[19].

---

Challenges and Opportunities

Challenge	Opportunity
Dose-limiting diarrhea (e.g., Plecanatide[7])	Development of dual-target therapies (e.g., NHE3 + SLC26A3[15])
High intra-subject variability in drug absorption[13]	Machine learning models to predict GI dynamics[13]
Generic competition post-2034[20]	Expansion into underserved markets (e.g., Asia-Pacific[19])

---

Future Outlook

• Pipeline Innovations: Focus on mucoadhesive formulations and pH-dependent coatings to enhance site-specific delivery[6].
• Clinical Trials: Tenapanor’s ongoing studies for CKD and IBS-C aim to broaden therapeutic indications[17].
• Market Expansion: Strategic licensing (e.g., AstraZeneca’s $237.5M deal with Ardelyx[18]) and regional partnerships will drive global uptake.

---

"The colon’s role in fluid/electrolyte balance has become a focal point for treating chronic conditions, with Tenapanor exemplifying the shift toward precision therapies." – Adapted from Frontiers in Pharmacology[7][15]

This evolving landscape underscores the interplay of mechanistic innovation, strategic IP management, and regional healthcare demands in shaping next-generation gastrointestinal therapeutics.

References

1. https://www.allucent.com/resources/blog/site-of-absorption-studies
2. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2017.00418/full
3. https://journals.physiology.org/doi/full/10.1152/ajpgi.00316.2021
4. https://pmc.ncbi.nlm.nih.gov/articles/PMC7933596/
5. https://academic.oup.com/bja/article/97/2/171/398223
6. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2020.00524/full
7. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2021.630249/full
8. https://pmc.ncbi.nlm.nih.gov/articles/PMC6723276/
9. https://sagaciousresearch.com/blog/patent-landscape-resistant-starch-filing-trends-top-players-innovation-hotspots/
10. https://pmc.ncbi.nlm.nih.gov/articles/PMC9310519/
11. https://patents.google.com/patent/US12016856B2/en
12. https://journals.plos.org/plosntds/article?id=10.1371%2Fjournal.pntd.0003119
13. https://pubmed.ncbi.nlm.nih.gov/37783928/
14. https://nesta.shorthandstories.com/food-innovation-patents/index.html
15. https://insight.jci.org/articles/view/121370
16. https://pmc.ncbi.nlm.nih.gov/articles/PMC6454550/
17. https://www.360iresearch.com/library/intelligence/tenapanor
18. https://www.drugdiscoverynews.com/astrazeneca-gains-license-for-ardelyx-s-nhe3-inhibitor-program-6684
19. https://www.qyresearch.com/reports/4666988/tenapanor
20. https://pharsight.greyb.com/drug/xphozah-patent-expiration