Drugs in MeSH Category Sequestering Agents

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	TABLET;ORAL	216517-001	Mar 10, 2023	AB	RX	No	No
Edenbridge Pharms	COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	TABLET;ORAL	217667-001	Aug 16, 2024	AB	RX	No	No
Impax Labs	COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	TABLET;ORAL	077510-001	Oct 24, 2006	AB	RX	No	Yes
Impax Labs	COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	GRANULE;ORAL	077277-002	May 2, 2006	AB	RX	No	No
Pfizer	COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563-003	Sep 22, 1995	AB	RX	Yes	No

Sequestering Agents Market Analysis and Financial Projection

The global market for sequestering agents is shaped by evolving regulatory landscapes, technological advancements, and strategic patent management. These agents, which bind metal ions or other molecules to prevent undesired interactions, are critical in pharmaceuticals, water treatment, and industrial applications. Below is an analysis of market dynamics and patent trends for drugs classified under the NLM MeSH category "Sequestering Agents."

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Market Dynamics

Growth Drivers

• Sustainability Initiatives: Increasing adoption of eco-friendly sequestering agents like sodium gluconate and hydroxycarboxylic acids aligns with global environmental regulations[1][11]. The shift toward green chemistry drives innovation, particularly in water treatment (28% market share) and agrichemicals[3][11].
• Pharmaceutical Demand: Sequestering agents play roles in drug stabilization and targeted delivery. For example, bile acid sequestrants (e.g., colestipol) are used to treat hyperlipidemia, with the market projected to reach $53.7 billion by 2037 due to rising cardiovascular diseases[16].
• Regional Expansion: Asia-Pacific leads growth (41.4% market share), driven by rapid industrialization in China and India, while North America focuses on oilfield and biomedical applications[11].

Challenges

• Patent Expirations: Key drugs like Taxol (paclitaxel) face generic competition post-patent expiry, prompting companies to develop "supergenerics" with improved formulations (e.g., nanoparticle albumin-bound paclitaxel)[2][15].
• Regulatory Hurdles: Bylvay (odevixibat), a bile acid sequestrant for cholestasis, faced FDA scrutiny over liver toxicity risks, delaying approval despite strong efficacy data[16].

Competitive Landscape

Market Leaders	Key Innovations
BASF, Dow, Mitsubishi	Aminopolycarboxylates for industrial cleaners
Abraxis Oncology	Nanoparticle drug delivery (e.g., Abraxane)
Ipsen Biopharmaceuticals	Bylvay for rare liver diseases

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Patent Landscape

Strategic Evergreening

Pharmaceutical companies extend market exclusivity through:

• Formulation Patents: Abuse-deterrent technologies (e.g., sequestered subunits with aversive agents) prevent tampering, as seen in opioids[10][13].
• Combination Therapies: Patents covering drug-device combinations or co-administered agents (e.g., fluticasone/vilanterol in Breo Ellipta)[17].

Key Patent Trends (2020–2025)

1. Bile Acid Sequestrants:

   • Odevixibat (Bylvay): 14 patents set to expire in 2025, opening pathways for generics targeting Alagille syndrome[17].
   • Colestipol: New polymer-based formulations enhance bile acid binding efficiency[14].

2. Anti-Cancer Agents:

   • 186 patent applications for KRAS G12C inhibitors highlight competition in covalent drug development[9].
   • Taxane derivatives dominate cytostatic sales despite patent cliffs, with lifecycle management strategies critical[2].

3. Abuse-Deterrent Technologies:

   • Patents like US8685443B2 and US7815934B2 describe osmotic-controlled release systems to limit aversive agent leakage for >24 hours[10][13].

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Role of MeSH Classification

The NLM MeSH system categorizes sequestering agents under D27.505 (Pharmacologic Actions), facilitating research tracking. For example:

• MeSH Term: Colestipol (D003084) links to studies on cholesterol management and drug delivery innovations[5][8].
• Patent Analysis: MeSH terms enable granular tracking of trends, such as 707 patent applications for covalent inhibitors targeting BTK, EGFR, and SARS-CoV-2 Mpro[9].

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Key Takeaways

1. Market Growth: CAGR of 4.4% through 2027, driven by eco-friendly agents and Asia-Pacific industrialization[3][11].
2. Patent Strategies: Evergreening and supergenerics mitigate revenue loss from expirations, while abuse-deterrent formulations address opioid misuse[10][15].
3. Clinical Impact: Bile acid sequestrants and targeted covalent drugs (e.g., Avastin) underscore the therapeutic and commercial potential of this class[9][16].

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“Competition is the backbone of the U.S. economy, but that’s not what we are seeing in the drug industry.” – Prof. Robin Feldman on patent evergreening[15].

References

1. https://sites.google.com/view/mri-research/home/sequestering-agent-marketby-type-and-by-application-2025
2. https://www.ufrgs.br/imunovet/molecular_immunology/anticancer.html
3. https://www.marketresearchintellect.com/product/global-sequestering-agent-market/
4. https://pmc.ncbi.nlm.nih.gov/articles/PMC10526705/
5. https://www.ncbi.nlm.nih.gov/mesh/68003084
6. https://www.ncbi.nlm.nih.gov/mesh?Cmd=DetailsSearch&Term=%22Pharmacologic+Actions%22%5BMeSH+Terms%5D
7. https://en.wikipedia.org/wiki/Medical_Subject_Headings
8. https://www.nlm.nih.gov/mesh/meshhome.html
9. https://pubmed.ncbi.nlm.nih.gov/39219095/
10. https://patents.google.com/patent/US8685443B2/en
11. https://www.fortunebusinessinsights.com/chelating-agents-market-104716/1000
12. https://patents.google.com/patent/EP1094989A1/en
13. https://patents.google.com/patent/US7815934B2/en
14. https://patents.google.com/patent/US9655920B2/en
15. https://www.uclawsf.edu/2020/09/24/patent-drug-database/
16. https://www.researchnester.com/reports/bile-acid-sequestrants-market/5452
17. https://pharsight.greyb.com/collections/drugs-opening-to-patent-challenges-in-2025