Drugs in MeSH Category Narcotics

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-005	Jan 4, 2012		DISCN	Yes	No			Y
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016		RX	Yes	No			Y
Impax Labs Inc	MORPHINE SULFATE	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	200411-006	Apr 12, 2016		DISCN	No	No
Sun Pharm Inds Ltd	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	203506-003	Apr 24, 2015		DISCN	No	No
Tris Pharma Inc	MORPHINE SULFATE	morphine sulfate	SOLUTION;ORAL	203519-001	May 18, 2016		DISCN	No	No
Watson Labs	MORPHINE SULFATE	morphine sulfate	INJECTABLE;INJECTION	073373-001	Sep 30, 1991		DISCN	No	No

Narcotics Market Analysis and Financial Projection

The market dynamics and patent landscape for narcotic drugs—classified under the National Library of Medicine’s MeSH term Narcotics (agents inducing narcosis or pain relief, primarily opioids)—reveal a complex interplay of growing demand, aggressive intellectual property strategies, and regulatory challenges. Here’s a breakdown of key trends:

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Market Dynamics

1. Growth Drivers

   • Chronic Disease Burden: Rising rates of cancer, arthritis, and postoperative pain management are fueling demand. The global narcotic drugs market is projected to grow at 4.6% CAGR (2025–2029), reaching $17.79 billion by 2029[3][8].
   • Opioid Use Disorder (OUD): Increased misuse has spurred the OUD treatment market, set to expand from $5.90 billion in 2025 to $15.32 billion by 2034 (11.18% CAGR)[13].

2. Regional Trends

   • North America dominates due to high chronic disease prevalence and robust healthcare infrastructure, accounting for ~40% of the narcotic drugs market[8].
   • Asia-Pacific is the fastest-growing region, driven by investments in healthcare and partnerships to tackle malaria and chronic pain[8][9].

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Patent Landscape

1. Strategies to Extend Monopolies

   • Patent Thickets: Drugmakers file hundreds of patents per drug to block competition. For example:
     • AbbVie’s Humira has 247 patent applications (132 granted) seeking 39 years of exclusivity[7][14].
     • Revlimid (cancer drug) has 96 patents aiming for 40 years of protection[7].
   • Evergreening: Minor modifications (e.g., dosage changes, formulations) extend patent life. 74% of patents for top-selling drugs are filed after FDA approval[15].

2. Impact on Prices and Access

   • Price Inflation: From 2012–2025, prices for top-selling drugs rose 68% on average, with Lyrica (Pfizer) spiking 163%[2][4].
   • Generic Delays: Patent thickets push generic entry delays to 38 years per drug vs. the intended 20-year monopoly[2][12]. In the U.S., Humira biosimilars were delayed until 2023 vs. 2018 in Europe[4].

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Regulatory and Market Challenges

1. Legal Scrutiny

   • South Africa’s Competition Commission is probing Johnson & Johnson over evergreening tactics for tuberculosis drug bedaquiline[16].
   • The U.S. USPTO disputes claims that patent counts correlate with exclusivity periods but acknowledges thickets are common for complex drugs[12].

2. Emerging Trends

   • Non-Opioid Alternatives: Companies are diversifying into synthetic and semi-synthetic narcotics to address addiction risks[8][10].
   • AI in Drug Development: Tools like GenAI predict patient outcomes and optimize pain management protocols[13].

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Case Studies

Drug	Patents Filed	Exclusivity Sought	Price Increase
Humira	247	39 years	470% (2003–2025)
Revlimid	96	40 years	50% (2014–2024)
Lantus (insulin)	49	37 years	300% (2010–2025)

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Key Takeaways

• Market Expansion: Driven by chronic diseases and OUD, but inflated by pricing strategies.
• Patent Abuse: Thickets and evergreening remain systemic, though USPTO scrutiny may curb extremes[12][15].
• Regional Disparities: North America faces higher prices due to laxer patent enforcement vs. Europe[4][16].
• Innovation vs. Access: Balancing R&D incentives with generic competition remains critical to affordability.

"The U.S. won’t get a Humira biosimilar until 2023. A lot of it is because pharmaceutical firms play these patent games to delay entry" — Dr. Shih-Ting (Tim) Tu, WVU College of Law[4].

References

1. https://meshb.nlm.nih.gov/record/ui?name=Narcotics
2. https://www.i-mak.org/wp-content/uploads/2018/08/I-MAK-Overpatented-Overpriced-Report.pdf
3. https://www.thebusinessresearchcompany.com/report/narcotic-drugs-global-market-report
4. https://wvutoday.wvu.edu/stories/2022/12/19/in-the-case-of-brand-name-drugs-vs-generics-patents-can-be-bad-medicine-wvu-law-professor-says
5. https://pubmed.ncbi.nlm.nih.gov/32772314/
6. https://library.rush.edu/c.php?g=1051232&p=7631221
7. https://accessiblemeds.org/resources/blog/pharmaceutical-patent-abuse-infinity-and-beyond/
8. https://www.databridgemarketresearch.com/reports/global-narcotic-drugs-market
9. https://www.globenewswire.com/news-release/2025/02/14/3026667/28124/en/2025-Hydroxychloroquine-Drugs-Market-Research-Report-Industry-Poised-for-Steady-Growth-Through-2030-Increasing-from-1-174-Billion-in-2025-to-1-336-Billion.html
10. https://pmc.ncbi.nlm.nih.gov/articles/PMC10598952/
11. https://pmc.ncbi.nlm.nih.gov/articles/PMC10370755/
12. https://c4ip.org/debunking-patent-disinformation-insights-from-the-usptos-drug-patent-and-exclusivity-study/
13. https://www.precedenceresearch.com/opioid-use-disorder-market
14. https://pirg.org/edfund/resources/the-cost-of-prescription-drug-patent-abuse/
15. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2818277
16. https://theweek.com/health/evergreening-big-pharmas-big-con