Drugs in MeSH Category Bronchodilator Agents

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes	8,491,932		Y
Boehringer Ingelheim	ALUPENT	metaproterenol sulfate	SYRUP;ORAL	017571-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Endo Operations	THEO-24	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	087943-002	Aug 22, 1983		RX	No	No
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014		RX	Yes	Yes	7,396,341*PED				Y
B Braun	THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER	theophylline	INJECTABLE;INJECTION	019083-001	Nov 7, 1984		DISCN	No	No

Bronchodilator Agents Market Analysis and Financial Projection

Last updated: March 24, 2025

The global bronchodilators market is experiencing steady growth driven by rising respiratory diseases and technological advancements, while recent legal challenges highlight evolving patent strategies in drug-device combinations.

Market Dynamics

Growing Demand and Segmentation

The bronchodilators market is projected to grow from USD 39.3 billion in 2024 to USD 57.7 billion by 2033 at a 4.15% CAGR[1], with alternative estimates suggesting even higher growth (5.9% CAGR to USD 67.8 billion by 2034)[6]. Key drivers include:

• Rising respiratory conditions: Asthma and COPD account for over 80% of the market[1][12], exacerbated by pollution and smoking.
• Innovative delivery systems: Inhalable formulations dominate (51.8% market share)[5], with mesh nebulizers and dry powder inhalers improving drug delivery efficiency[11][13].
• COVID-19 impact: Increased use of bronchodilators for managing virus-related respiratory complications[1].

Market segmentation:	Category	Leading Segments	Growth Drivers
Drug Class	Anticholinergics (40% share)[1]	Efficacy in COPD management and availability in long/short-acting forms[12].
Route	Inhalable (51.8% share)[5]	Improved patient compliance and technologies like co-suspension MDIs[7][9].
Region	North America (>40% share)[1][12]	High COPD prevalence and strong IP protection for devices like ProAir HFA[4][10].

Patent Landscape and Legal Challenges

Key Innovations and Litigation

1. Device vs. Drug Patents:

   • Teva’s ProAir HFA inhaler patents (covering dose counters/canisters) were delisted from the FDA Orange Book after courts ruled they didn’t protect the active ingredient (albuterol sulfate)[2][4][10].
   • Impact: Allows generics like Amneal’s ANDA product to enter the market, reducing costs[4].

2. Technological Advancements:

   • Co-suspension MDIs: Pearl Therapeutics’ US Patent 8,324,266 enables stable combination therapies (e.g., glycopyrrolate + formoterol)[7].
   • Mesh nebulizers: Patented designs using polyoxymethylene improve fine-particle dose delivery by 20–40%[9][13].

Emerging Trends

• MABA therapies: Dual-action bronchodilators like indacaterol simplify treatment regimens[15].
• Digital inhalers: Devices like ProAir Digihaler integrate sensors for dose tracking[5].

Regulatory and Competitive Pressures

• Hatch-Waxman Act: Requires accurate Orange Book listings, with FTC actively challenging improper patents[2][10].
• Generic competition: 80% of β-agonist sales come from generics like albuterol[5], prompting originators to focus on device patents[17].

The bronchodilator market is balancing innovation in drug-device combinations with regulatory scrutiny, ensuring broader access while protecting incentivized R&D. Asia-Pacific’s growth (5.3–5.9% CAGR)[6][12] and next-gen nebulizers signal future opportunities, though patent strategies must adapt to prioritize therapeutic claims over device components.

References

1. https://www.imarcgroup.com/bronchodilators-market
2. https://ipwatchdog.com/2024/06/12/amneal-aided-ftc-succeeds-getting-teva-patents-removed-orange-book/id=177969/
3. https://www.ncbi.nlm.nih.gov/mesh?Db=mesh&Cmd=DetailsSearch&Term=%22Epinephrine%22%5BMeSH+Terms%5D
4. https://www.biospace.com/teva-loses-inhaler-patent-case-against-amneal-must-delete-or-amend-orange-book-listing
5. https://www.grandviewresearch.com/industry-analysis/bronchodilators-market-report
6. https://www.futuremarketinsights.com/reports/bronchodilator-market
7. https://drug-dev.com/pearl-therapeutics-issued-us-patent-on-co-suspension-formulation-technology/
8. https://en.wikipedia.org/wiki/List_of_MeSH_codes_(D27)
9. https://patents.google.com/patent/US20190076607A1/en
10. https://patentlyo.com/patent/2024/12/orange-listings-understanding.html
11. https://pubmed.ncbi.nlm.nih.gov/29325508/
12. https://www.alliedmarketresearch.com/bronchodilators-market
13. https://touchrespiratory.com/asthma/journal-articles/vibrating-mesh-nebulisers-can-greater-drug-delivery-to-the-airways-and-lungs-improve-respiratory-outcomes/
14. https://publications.ersnet.org/content/erj/34/3/757
15. https://publications.ersnet.org/content/erj/42/4/885
16. https://pmc.ncbi.nlm.nih.gov/articles/PMC4444630/
17. https://pmc.ncbi.nlm.nih.gov/articles/PMC10475818/
18. https://www.vectura.com/wp-content/uploads/2020/03/Vectura_Group_plc_Annual_Report_and_Accounts_2018_1.pdf