Drugs in MeSH Category Antitussive Agents

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	CODEINE SULFATE	codeine sulfate	TABLET;ORAL	022402-001	Jul 16, 2009	AB	RX	Yes	No
Hikma	CODEINE SULFATE	codeine sulfate	TABLET;ORAL	022402-003	Jul 16, 2009	AB	RX	Yes	Yes
Hikma Farmaceutica	BUTORPHANOL TARTRATE	butorphanol tartrate	INJECTABLE;INJECTION	078247-001	Apr 29, 2009		DISCN	No	No
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-004	Oct 25, 2013		DISCN	Yes	No

Antitussive Agents Market Analysis and Financial Projection

The global antitussive drugs market, valued at USD 1.3 billion in 2022, is projected to reach USD 1.88 billion by 2030, growing at a CAGR of 4.6–4.7% (2023–2030)[1][4][6]. This growth is driven by rising respiratory diseases, aging populations, and increased healthcare spending, but challenged by safety concerns, generic competition, and regulatory hurdles.

Market Dynamics

Growth Drivers

• Respiratory Disease Burden: Over 262 million people globally suffer from asthma (WHO, 2019), with chronic cough prevalence at 10–33% of the population[6].
• Regional Growth:
  • North America dominates (45% market share)[6], fueled by FDA approvals and high healthcare expenditure[1].
  • Asia-Pacific shows rapid growth due to government initiatives in India and China to boost pharmaceutical sectors[1][4].

Challenges

• Safety Concerns: Opioids like codeine, though widely prescribed, face scrutiny for dependency risks and inconsistent efficacy[3].
• Generic Erosion: Expiry of patents (e.g., dextromethorphan formulations[7]) enables generic substitution, reducing revenue for branded products[16].
• Regulatory Complexities: High costs and prolonged timelines for clinical trials delay new drug approvals[16].

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Patent Landscape

Key Trends

1. Formulation Innovations:

   • Extended-Release Technologies: Patents cover dextromethorphan-tannic acid complexes for prolonged action (e.g., US 6001392)[2].
   • Combination Therapies: Examples include antitussives paired with anesthetics (US 5100898)[2] or antihistamines (US 6869618)[2].

2. Pediatric and Delivery Optimization:

   • Pediatric Formulations: Over 14% of Chinese antitussive patents target pediatric use, employing syrups and dispersible tablets[13].
   • Liquid Suspensions: Patents address stability and palatability for oral drops (RU 2427388C2)[7].

3. Geographical Focus:

   • US and EU: Lead in novel delivery systems and combination therapies (e.g., Warner-Lambert’s resin-based formulations)[2].
   • China: Dominates traditional medicine patents (684 formulations), though standardization challenges persist[13].

Innovation Gaps

• Pipeline Stagnation: No novel antitussive drug class has been FDA-approved in 50 years; recent patents focus on reformulations rather than new molecules[3][16].
• Covalent Drug Development: While covalent inhibitors for targets like EGFR and BTK surged (707 patents in 2020–23)[5], antitussives remain underrepresented.

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Strategic Insights

• Unmet Needs: Demand persists for non-opioid alternatives with fewer side effects. Dextromethorphan remains central, featured in 45% of patents[2][7].
• Competition: Over 100 organizations compete in ADC-linked therapies[11], but antitussives see limited novel target engagement.
• Regulatory Strategies: Ultra-long patent terms, proposed for antibiotics[14], could incentivize antitussive R&D by extending market exclusivity.

In summary, while the antitussive market grows steadily, innovation remains incremental. Future breakthroughs hinge on overcoming regulatory barriers and prioritizing novel mechanisms over reformulations.

Highlight:

"The last US-approved antitussive, dextromethorphan, entered the market in the 1950s—highlighting a critical need for new molecular entities." [3][6]

References

1. https://www.globenewswire.com/news-release/2023/07/04/2698831/0/en/Global-Antitussive-Drugs-Market-Size-Is-Set-to-Hit-USD-1876-9-Million-Mark-by-2030-With-a-CAGR-of-4-62.html
2. https://patents.justia.com/patents-by-us-classification/514/850
3. https://pubmed.ncbi.nlm.nih.gov/21757975/
4. https://www.zionmarketresearch.com/report/antitussive-drugs-market
5. https://pubmed.ncbi.nlm.nih.gov/39219095/
6. https://www.databridgemarketresearch.com/reports/global-antitussive-drugs-market
7. https://patents.google.com/patent/RU2427388C2/en
8. https://www.pharmacompass.com/chemistry-chemical-name/dolosal
9. https://meshb-prev.nlm.nih.gov/record/ui?name=Antitussive+Agents
10. https://en.wikipedia.org/wiki/List_of_MeSH_codes_(D27)
11. https://www.fbrice.com.au/ip-news-insights/traversing-a-dynamic-adc-patent-landscape-2/
12. https://www.scirp.org/journal/paperinformation?paperid=89601
13. https://pesquisa.bvsalud.org/portal/resource/pt/wpr-439889
14. https://houstonhealthlaw.scholasticahq.com/article/31474-
15. https://www.wipo.int/edocs/pubdocs/en/patents/946/wipo_pub_946.pdf
16. https://www.techsciresearch.com/report/antitussive-drugs-market/17246.html