Mast Cell Stabilizer Drug Class List

Drugs in Drug Class: Mast Cell Stabilizer

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ailex Pharms Llc	CROMOLYN SODIUM	cromolyn sodium	CONCENTRATE;ORAL	209264-001	Oct 16, 2017	AA	RX	No	No
Ailex Pharms Llc	CROMOLYN SODIUM	cromolyn sodium	SOLUTION;INHALATION	209453-001	Oct 16, 2017	AN	RX	No	No
Allergan	ALOCRIL	nedocromil sodium	SOLUTION/DROPS;OPHTHALMIC	021009-001	Dec 8, 1999		DISCN	Yes	No
Micro Labs	CROMOLYN SODIUM	cromolyn sodium	SOLUTION;INHALATION	213658-001	Apr 29, 2022	AN	RX	No	No
Sandoz	CROMOLYN SODIUM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	075282-001	Jun 16, 1999		RX	No	Yes
Sciegen Pharms Inc	CROMOLYN SODIUM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	074706-001	Apr 29, 1998		DISCN	No	No
Virtus	CROMOLYN SODIUM	cromolyn sodium	SOLUTION;INHALATION	075437-001	Apr 21, 2000	AN	RX	No	No

Mast Cell Stabilizer Market Analysis and Financial Projection

The mast cell stabilizers market is experiencing steady growth driven by increasing allergy prevalence and therapeutic innovations, while the patent landscape reflects strategic intellectual property (IP) management to secure long-term market exclusivity.

Market Dynamics

• Market Size & Growth:
  Valued at $1.95–2.05 billion in 2022, the market is projected to reach $3.3–3.62 billion by 2030–2031, growing at a 6.5–6.8% CAGR. Growth is fueled by rising asthma/allergy cases, allergen exposure from global travel, and the shift of some drugs to over-the-counter (OTC) status[1][4][11].

• Key Segments:

  • Product Type: Oral medications dominate due to patient convenience[1][4].
  • Indication: Asthma leads demand, followed by indolent systemic mastocytosis (33.8% market share in 2023)[1][6].
  • Distribution: Hospital pharmacies exhibit the highest growth, driven by severe case management[1][4].

• Regional Trends:

  • North America holds the largest share (39.5% in 2023), benefiting from high healthcare spending and established players[1][4].
  • Asia-Pacific is the fastest-growing region (7.3% CAGR), driven by increasing allergy prevalence and cost-effective generics[4][6].

• Challenges:
  Generic competition, limited drug indications, and slow adoption due to delayed therapeutic effects hinder growth[1][11].

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Patent Landscape

• Key Patents & Innovations:

  • Masitinib (AB Science):
  • European patents grant exclusivity for severe systemic mastocytosis until 2036 and sickle cell disease until 2040, supported by preclinical data[2][5][12].
  • Orphan drug designation in the EU and US provides additional market exclusivity (10 and 7 years, respectively)[5][12].
  • Mechanistic Advances:
    Development of monoclonal antibodies (e.g., omalizumab) and single-domain antibodies (sdAbs) improves targeting specificity, reducing side effects[3].
  • Repurposed Drugs:
    Tacrolimus and artesunate show off-label mast cell-stabilizing effects, expanding treatment options[3].

• Strategic IP Trends:

  • Companies like AB Science focus on indication-specific patents to prolong IP protection across multiple diseases (e.g., Alzheimer’s, prostate cancer)[9][12].
  • Over 15% of mastocytosis-related patents focus on combination therapies (e.g., stabilizers with antihistamines), enhancing efficacy[11].

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Competitive Landscape

• Leading Players: Viatris, AbbVie, Merck, and Alcon lead the market, while AB Science pioneers kinase inhibitors like masitinib[1][4][15].
• Emerging Opportunities:
  • Personalized Medicine: Tailored therapies for mast cell activation syndrome (MCAS) and rare diseases[11].
  • Pipeline Drugs: Montelukast (leukotriene inhibitor) is under investigation for MCAS, potentially expanding applications[4].

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Future Outlook

The market will likely see accelerated growth through 2023–2040, driven by biologic innovations (e.g., mAbs) and Asia-Pacific’s expanding healthcare access. Patent expirations post-2036 may increase generic competition, but indication-specific IP strategies and orphan drug designations will sustain revenue for key players[2][4][12].

“The improvement of each generation [of mAbs] is mainly focused on the affinity for IgE and the reduction of IgE production.” – Frontiers in Immunology[3]

Key Takeaways:

• Market growth is robust, with oral medications and hospital pharmacies as primary drivers.
• AB Science’s masitinib patents exemplify targeted IP strategies to secure long-term exclusivity.
• Innovation in biologics and drug repurposing will shape future therapeutic landscapes.

References

1. https://www.credenceresearch.com/report/mast-cell-stabilizers-market
2. https://www.biospace.com/press-releases/ab-science-receives-notice-of-allowance-for-european-patent-covering-masitinib-until-2040-in-the-treatment-of-sickle-cell-disease
3. https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1418897/full
4. https://www.growthplusreports.com/report/mast-cell-stabilizers-market/9232
5. https://www.rarediseaseadvisor.com/news/masitinib-receives-noa-treatment-sm/
6. https://market.us/report/indolent-systemic-mastocytosis-treatment-market/
7. https://www.acumenresearchandconsulting.com/systemic-mastocytosis-treatment-market
8. https://patents.google.com/patent/US20160346245A1/en
9. https://www.biospace.com/ab-science-announces-issuance-of-a-european-patent-for-masitinib-in-the-treatment-of-severe-mastocytosis-with-protection-until-2036
10. https://patents.google.com/patent/US20190307721A1/en
11. https://www.verifiedmarketreports.com/product/mast-cell-stabilizer-market/
12. https://synapse.patsnap.com/article/ab-science-secures-european-patent-for-masitinib-in-severe-mastocytosis-treatment-until-2036
13. https://patents.google.com/patent/JP2007126388A/en
14. https://www.wipo.int/edocs/pubdocs/en/wipo_pub_947_5.pdf
15. https://www.databridgemarketresearch.com/reports/global-mastocytosis-drug-market