Drugs in MeSH Category Expectorants

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Guardian Drug	GUAIFENESIN	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	209215-002	Sep 6, 2017		OTC	No	No
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes
Apothecon	MUCOMYST	acetylcysteine	SOLUTION;INHALATION, ORAL	013601-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Rising	POTASSIUM CITRATE	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	077440-002	Jun 9, 2006	AB	RX	No	No
Somerset Theraps Llc	ACETYLCYSTEINE	acetylcysteine	SOLUTION;INHALATION, ORAL	219194-002	Feb 12, 2025	AN	RX	No	No
Rb Hlth	MUCINEX	guaifenesin	TABLET, EXTENDED RELEASE;ORAL	021282-002	Dec 18, 2002		OTC	Yes	Yes

Expectorants Market Analysis and Financial Projection

Last updated: March 24, 2025

The expectorant drugs market is experiencing robust growth driven by post-pandemic respiratory health awareness and evolving pharmaceutical strategies. Valued at $2.91 billion in 2025, the market is projected to reach $4.53 billion by 2035, growing at a 4.5% CAGR[1][4]. North America dominates due to high rates of chronic respiratory conditions like COPD and asthma[4][8], while South Asia emerges as a fast-growing region fueled by urbanization and pollution-related health issues[8]. Key players such as Merck KGaA and Johnson & Johnson focus on product innovation, including extended-release formulations and over-the-counter approvals[4][6].

Market Dynamics

• Growth Drivers: Increased smoking rates, aging populations, and air pollution amplify demand[1][4]. Post-COVID-19 healthcare investments and public health campaigns further accelerate adoption[1][8].
• Regional Trends:
  • North America: 8.7% of U.S. adults have asthma, driving guaifenesin-based drug approvals[4].
  • South Asia: Rapid urban expansion and rising healthcare access boost market penetration[8].
• Competitive Landscape: Companies prioritize regulatory approvals (e.g., Marksans Pharma’s 2023 FDA clearance for Guaifenesin tablets) and OTC expansions (e.g., Granules India’s 2022 launch)[4].

Patent Landscape

• Authorized Generics (AGs): Branded drugs often launch AGs during the 180-day exclusivity period of first-filer generics, reducing generic revenues by ~40%[2]. This tactic can deter future patent challenges[2].
• Key Patents:
  • Obredon (guaifenesin solution): Protected until 2035 under patents like US9549907[6].
  • COVID-19 formulations: Patents like US11638722 target viral pathways using multi-agent strategies[9].
  • Extended-release technologies: Patents such as US20090202633A1 focus on bilayer tablets for sustained efficacy[12].
• Legal Strategies: “Pay-for-delay” settlements sometimes involve brands withholding AGs to compensate generics for delayed entry, raising antitrust concerns[2][10].

MeSH Classification Insights
Expectorants are categorized under pharmacological agents affecting respiratory mucus clearance (e.g., MeSH D27.505.954.427.153)[7]. Adjacent codes include:

• Antitussives: Cough suppressants acting centrally (MeSH D000996)[7].
• Cholinergic agents: Subcategories like muscarinic agonists/antagonists (D27.505.519.625.120)[3].

Blockchain and personalized medicine trends are expected to reshape drug delivery and IP strategies, while herbal expectorants gain traction in markets emphasizing natural remedies[5][9].

“AGs harm competition by drawing revenues away from generic firms during the 180-day exclusivity period.” — FTC Report[2]

References

1. https://www.futuremarketinsights.com/reports/expectorant-drugs-market
2. https://www.ftc.gov/sites/default/files/documents/reports/authorized-generic-drugs-short-term-effects-and-long-term-impact-report-federal-trade-commission/authorized-generic-drugs-short-term-effects-and-long-term-impact-report-federal-trade-commission.pdf
3. https://en.wikipedia.org/wiki/List_of_MeSH_codes_(D27)
4. https://www.mordorintelligence.com/industry-reports/expectorant-drugs-market
5. https://www.theinsightpartners.com/reports/expectorants-market
6. https://pharsight.greyb.com/drug/obredon-patent-expiration
7. https://meshb.nlm.nih.gov/record/ui?ui=D000996
8. https://www.persistencemarketresearch.com/market-research/expectorant-drugs-market.asp
9. https://patents.justia.com/patents-by-us-classification/514/855
10. https://irlaw.umkc.edu/context/faculty_works/article/1223/viewcontent/Branded_Drug_Companies_Are_Successfully_Asserting_the_Doctrine_of.pdf
11. https://pharsight.greyb.com/drug/mucinex-patent-expiration
12. https://patents.google.com/patent/US20090202633A1/en
13. https://www.globenewswire.com/news-release/2024/01/23/2813814/0/en/Expectorant-Drugs-Market-Poised-to-Reach-US-22-9-Billion-by-2030-with-a-Steady-4-5-CAGR-Persistence-Market-Research.html
14. https://conservancy.umn.edu/bitstreams/26509c6c-4364-4906-bdb0-3cbf6205c898/download
15. https://www2.ntia.doc.gov/files/grantees/auburn_pcc_application_attachments_part1_redacted.pdf