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
Bayer	8-HOUR BAYER	aspirin	TABLET, EXTENDED RELEASE;ORAL	016030-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010		DISCN	Yes	No					Y
Ohm Labs	ACETAMINOPHEN	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	076200-001	Mar 19, 2002		OTC	No	No
Plx Pharma	VAZALORE	aspirin	CAPSULE;ORAL	203697-001	Jan 14, 2013		OTC	Yes	Yes			Y

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/