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Last Updated: July 17, 2025

Drugs in MeSH Category Expectorants


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

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

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