Drugs in MeSH Category HIV Integrase Inhibitors

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET;ORAL	022145-001	Oct 12, 2007		RX	Yes	Yes	7,754,731*PED				Y
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011		RX	Yes	No	7,754,731*PED				Y
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011		RX	Yes	Yes	7,754,731*PED				Y
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017		RX	Yes	Yes	7,754,731*PED				Y
Hetero Labs Ltd Iii	RALTEGRAVIR POTASSIUM	raltegravir potassium	TABLET;ORAL	203540-001	Dec 19, 2024		DISCN	No	No
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017		RX	Yes	Yes	10,772,888
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017		RX	Yes	Yes	9,649,311*PED				Y

HIV Integrase Inhibitors Market Analysis and Financial Projection

The market for HIV integrase inhibitors is experiencing steady growth driven by high HIV prevalence and advancements in antiretroviral therapies. Valued at USD 27.66 billion in 2022, the market is projected to reach USD 40.56 billion by 2031 (4.5% CAGR)[1], while another report estimates it at USD 14.7 billion in 2023, expanding to USD 21.7 billion by 2030 (5.7% CAGR)[5]. North America dominates, accounting for the largest revenue share due to robust healthcare infrastructure and high HIV incidence[1][10].

Market Drivers and Trends

• Increasing HIV Burden: Over 38 million people live with HIV globally, driving demand for integrase inhibitors as first-line therapy[5][14].
• Innovative Drug Approvals: Long-acting injectables like cabotegravir and multi-class combinations improve adherence and efficacy[4][14].
• Government Initiatives: Expanded testing and treatment programs in developing regions, coupled with funding for HIV prevention, bolster market growth[1][14].

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Patent Landscape

The patent ecosystem for HIV integrase inhibitors is marked by strategic filings and evolving R&D priorities:

Aspect	Details
Key Players	Merck (raltegravir), Gilead (bictegravir), ViiV Healthcare (dolutegravir)[1][12][14].
Patent Strategies	- Evergreening: Secondary patents on formulations (e.g., potassium salts of raltegravir)[12][13]. - Combination Therapies: Co-formulations with reverse transcriptase inhibitors[2][4].
Emerging Targets	- Allosteric Inhibitors: LEDGINs targeting integrase-LEDGF/p75 interaction (preclinical)[15]. - Dual-Action Drugs: Inhibitors targeting integrase and RNase H[8].
Expiring Patents	Merck’s raltegravir patents expire between 2023 and 2029, paving the way for generics[12].

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Competitive Dynamics

• Dominant Drugs: Second-generation INSTIs (dolutegravir, bictegravir) dominate due to high potency and resistance profiles[4][8].
• R&D Focus: Developing third-generation INSTIs with enhanced resistance barriers and nano-formulations for sustained release[4][8].
• Regional Growth: Asia-Pacific shows rapid growth due to improving healthcare access and rising R&D investments[1][10].

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Challenges and Future Outlook

• Resistance Mutations: INSTI-resistant strains (e.g., Q148H/G140S) necessitate novel inhibitors targeting non-catalytic sites[9][15].
• Cost and Access: High drug prices in low-income regions limit uptake, though generic approvals may alleviate this[12][14].
• Next-Gen Innovations: Allosteric inhibitors and dual-target therapies aim to address latency and integration mechanisms[8][15].

"Understanding structural interactions between integrase and host factors will unlock new therapeutic avenues." [8][15]

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Key Takeaways

1. The HIV integrase inhibitors market grows at 4.5–5.7% CAGR, fueled by innovation and HIV prevalence.
2. Patent strategies prioritize formulation tweaks and combination therapies to extend exclusivity.
3. North America leads adoption, while Asia-Pacific emerges as a high-growth region.
4. Overcoming resistance and improving affordability remain critical for long-term success.

FAQs

1. What drives the growth of integrase inhibitors?
   Rising HIV cases and approval of long-acting therapies like cabotegravir[5][14].
2. How do patents impact market access?
   Evergreening delays generics, but expiring patents (e.g., raltegravir) may lower costs[12][13].
3. What are LEDGINs?
   Experimental allosteric inhibitors targeting HIV integrase’s interaction with LEDGF/p75[15].
4. Which regions dominate the market?
   North America holds >40% share due to high healthcare spending and innovation[1][10].
5. What challenges persist?
   Drug resistance and cost barriers in low-income countries[9][14].

Sources: [1][2][4][5][8][9][10][12][13][14][15]

References

1. https://www.insightaceanalytic.com/report/integrase-inhibitors-market/2089
2. https://www.wipo.int/publications/en/details.jsp?id=230
3. https://pmc.ncbi.nlm.nih.gov/articles/PMC8205226/
4. https://pubmed.ncbi.nlm.nih.gov/36750766/
5. https://www.coherentmarketinsights.com/market-insight/integrase-inhibitors-market-6023/market-size-and-trends
6. http://www.i-mak.org/wp-content/uploads/2017/10/I-MAKHIVDrugPatentsinChinaTahirAminMay2010.pdf
7. https://en.wikipedia.org/wiki/Integrase_inhibitor
8. https://pmc.ncbi.nlm.nih.gov/articles/PMC7004278/
9. https://pmc.ncbi.nlm.nih.gov/articles/PMC3259799/
10. https://www.imarcgroup.com/north-america-hiv-drugs-market
11. https://pubs.acs.org/doi/10.1021/jm0201417
12. https://ipwatchdog.com/2013/07/10/fda-approves-new-labeling-for-merck-blockbuster-hiv-drug-isentress/id=43149/
13. https://patents.google.com/patent/US7741315B2/en
14. https://www.expertmarketresearch.com/reports/hiv-drugs-maket
15. https://pubmed.ncbi.nlm.nih.gov/24666332/
16. https://pubmed.ncbi.nlm.nih.gov/12477350/
17. https://pubmed.ncbi.nlm.nih.gov/9083482/
18. https://pmc.ncbi.nlm.nih.gov/articles/PMC7569752/