Drugs in MeSH Category Antipyretics

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kenvue Brands	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994		OTC	Yes	Yes
Marksans Pharma	ACETAMINOPHEN	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	215486-001	Aug 25, 2021		OTC	No	No
Sun Pharm Inds Ltd	ACETAMINOPHEN	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	078569-001	Dec 14, 2011		DISCN	No	No

Antipyretics Market Analysis and Financial Projection

The antipyretics market and its patent landscape reflect a dynamic interplay between clinical demand, therapeutic innovation, and intellectual property strategies. Below we analyze key trends shaping this pharmaceutical sector.

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Market Dynamics of Antipyretics

The global antipyretics market is projected to reach $3.1 billion by 2027, growing at a CAGR of 1.6% (2022–2027)[1]. This growth is fueled by:

• Rising disease burden: Seasonal flu causes ~47,000 annual U.S. hospitalizations[1], while migraines affect 45 million Americans[1].
• COVID-19 tailwinds: Fever occurred in 85.6% of COVID-19 cases[1], accelerating demand for NSAIDs and acetaminophen.
• OTC expansion: Recent approvals like Strides Pharma’s ibuprofen oral suspension (2022)[1] and injectable formulations (e.g., Cumberland Pharmaceuticals’ 2020 launch)[1] enhance accessibility.

Key players include Dr. Reddy’s, Cipla, Pfizer, and Novartis, with generics intensifying cost competition[1][14].

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Patent Landscape Analysis

Innovation Trends

1. Formulation Advances:

   • Combination therapies: Patents cover ibuprofen/acetaminophen blends (US5409709A)[10] to reduce gastric toxicity.
   • Stereochemical optimization: R(-)-ketoprofen patents (US5331000-A)[9] claim reduced hepatic/renal side effects.

2. Evergreening Strategies:

   • Secondary patents focus on crystalline forms, dosage formulations, and synthesis intermediates[2][6]. For example, Ritonavir’s patent family expanded via liquid/solid dosage claims[2].

3. Viral Applications:
   Post-pandemic filings increasingly target antiviral combinations, as seen in hepatitis C therapies involving pibrentasvir[6][13].

Regional Patent Activity

• U.S. dominance: 45% of antipyretic-related patent families originate here[2].
• Asia-Pacific growth: Generic manufacturers leverage expired patents while investing in novel delivery systems[14].

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MeSH Classification & Research Trends

The NLM’s Medical Subject Headings (MeSH) categorize antipyretics under D03.383.129.539.850.088, with key terms:

• Antipyrine: Used to study drug-metabolizing enzymes[7].
• Analgesic synergy: MeSH-based PubMed analyses reveal NSAID/acetaminophen combinations as 50% more effective than monotherapy[8][11].

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Challenges & Opportunities

Challenges	Opportunities
Generic price erosion[1]	Emerging markets (e.g., India’s 31.7% NEML expansion)[4]
Opioid crisis scrutiny[8]	Long-COVID therapeutic trials[1]
Hepatotoxicity risks[8][9]	AI-driven drug repurposing[11]

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Future Outlook

1. Personalized formulations: Nanoparticle-based delivery systems aim to reduce dosing frequency[12].
2. Digital integration: Telemedicine platforms drive OTC sales growth (10.6% CAGR forecast for 2025–2032)[14].
3. Sustainability shifts: Herbal antipyretics gain traction, with China adding 65 traditional medicines to its 2018 Essential List[4].

“The interplay of regulatory frameworks and therapeutic innovation will define antipyretics’ next decade.” – IndustryARC Market Analysis[1].

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Key Takeaways

• Antipyretics remain cornerstone therapies for fever/pain management despite genericization pressures.
• Patent strategies increasingly prioritize lifecycle management through formulation patents.
• MeSH taxonomy enables precision in tracking clinical research trends.

FAQs

1. Which antipyretic has the lowest toxicity profile?
   R(-)-ketoprofen shows reduced hepatic risks vs. racemic forms[9].
2. How did COVID-19 impact antipyretic R&D?
   It accelerated 26+ clinical trials targeting inflammation in long-COVID[1].
3. What’s driving Asia-Pacific market growth?
   India’s pharmaceutical exports grew 103% since 2013, aided by API production[4][14].
4. Are herbal antipyretics patentable?
   Yes, but only with novel extraction/delivery methods (e.g., standardized turmeric formulations)[4].
5. How do MeSH terms aid patent analysis?
   They enable cross-linking between clinical research and IP filings via PubMed/Patents.gov integration[11][15].

References

1. https://www.industryarc.com/PressRelease/2837/antipyretics-market-research.html
2. https://www.wipo.int/edocs/pubdocs/en/wipo_pub_946_1-tech1.pdf
3. https://www.youtube.com/watch?v=o6CTfdx85ys
4. https://www.biosciencetrends.com/files/BST_2018Vol12No5_pp445_525.pdf
5. https://www.360iresearch.com/library/intelligence/adult-antipyretics
6. https://unitaid.org/uploads/Pibrentasvir_patent-landscape_March2017.pdf
7. https://www.ncbi.nlm.nih.gov/sites/entrez?Db=mesh&Cmd=DetailsSearch&Term=%22Antipyrine%22%5BMeSH+Terms%5D
8. https://www.ncbi.nlm.nih.gov/books/NBK458655/
9. https://pubchem.ncbi.nlm.nih.gov/patent/US-5331000-A
10. https://patents.google.com/patent/US5409709A/en
11. https://pmc.ncbi.nlm.nih.gov/articles/PMC8859845/
12. https://www.science.gov/topicpages/c/control+volume+formulation.html
13. https://www.southcentre.int/wp-content/uploads/2022/04/RP153_Patent-Analysis-for-Medicines-and-Biotherapeutics-in-Trials-to-Treat-COVID-19_EN-1.pdf
14. https://github.com/omduthkevork/Market-Research-Report-List-1/blob/main/antipyretic-analgesics-market.md
15. https://pubmed.ncbi.nlm.nih.gov/20865561/

Last updated: 2025-03-24