Drugs in MeSH Category Analgesics, Opioid

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	9,241,935		Y
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016		RX	Yes	No	10,646,485		Y
Impax Labs Inc	MORPHINE SULFATE	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	200411-006	Apr 12, 2016		DISCN	No	No
Osmotica Pharm Us	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205629-002	Jul 7, 2016	AB	RX	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

Analgesics, Opioid Market Analysis and Financial Projection

The global opioid analgesics market is navigating a complex landscape shaped by evolving regulatory frameworks, public health crises, and pharmaceutical innovations. With chronic pain affecting over 1.5 billion people worldwide, opioid analgesics remain critical for pain management, but their role is being redefined by safety concerns and alternatives.

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Market Dynamics

Growth Drivers

• Chronic Pain Prevalence: Rising cases of post-surgical, cancer-related, and neuropathic pain drive demand, particularly among aging populations. Chronic pain affects 20.4% of U.S. adults, with 8% experiencing debilitating symptoms[18].
• Abuse-Deterrent Formulations (ADFs): Innovations like Purdue Pharma’s faster-acting buprenorphine "wafer" for addiction treatment[5] and Pain Therapeutics’ agonist-antagonist combinations aim to balance efficacy with reduced abuse potential[9].
• Oral Route Dominance: Oral opioids account for 38% of retail pharmacy sales due to convenience and diverse formulations (immediate/extended-release)[1]. This segment anticipates a 2.5% CAGR through 2034[1].

Challenges

• Regulatory Scrutiny: Prescription limits and litigation (e.g., Purdue Pharma’s $600 million 2007 settlement[5]) constrain growth. Germany’s strict prescribing rules exemplify this trend[3].
• Opioid Crisis: Over 48,000 U.S. overdose deaths in 2022 highlight risks[12]. Synthetic opioids like fentanyl now drive 70% of fatalities[12].
• Non-Opioid Competition: Medical marijuana, neuromodulation, and biologics are gaining traction[3][18].

Regional Trends	Region	Market Size (2023)	Projected CAGR (2024–2034)	Key Factors
North America	$7.18 billion[1]	2%[1]	High chronic pain rates, ADF adoption
Asia-Pacific	—	China: 8.1%[3]	Aging population, cancer care demand
Europe	—	Germany: 4.2%[3]	Strict regulations, palliative focus

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Patent Landscape

Key Innovation Areas

1. Overdose Reversal:

   • Intranasal naloxone: Concentrated formulations (10–40 mg/mL) achieve 21–57% bioavailability, enabling rapid response to overdoses[2].
   • Non-injectable routes (sublingual, buccal) address accessibility barriers[2].

2. Addiction Treatment:

   • Buprenorphine advancements: Purdue’s fast-dissolving wafer targets cravings[5].
   • AD04: Adial Pharmaceuticals’ genotype-specific therapy for opioid dependence (targeting SLC6A4 gene variants)[15].

3. Formulation Innovations:

   • Abuse-deterrent opioids: Pain Therapeutics’ MorViva and OxyTrex combine agonists with low-dose antagonists to reduce addiction risk[9].
   • Synthetic opioids: Fentanyl’s 46 patents highlight its role in palliative care, despite overdose risks[14].

4. Non-Opioid Targets:

   • Sigma ligands (e.g., US9844516B2) target post-operative pain without traditional opioid receptors[10].
   • Small molecules addressing dopamine/glutamate pathways aim to disrupt addiction circuits[13].

Notable Patents (2018–2025)	Patent Focus	Example	Impact
Abuse deterrence	Pain Therapeutics’ agonist-antagonist blends[9]	Reduce misuse potential
Genetic targeting	Adial’s rs1042173 genotype therapy[15]	Personalized addiction treatment
Overdose reversal	Concentrated intranasal naloxone[2]	Faster emergency response

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Strategic Outlook

The opioid analgesics market is projected to reach $26.78 billion by 2034[1], with growth hinging on:

• Balancing access and safety: ADFs and naloxone accessibility (e.g., Harm Reduction Therapeutics’ OTC development[5]).
• Regional diversification: India and Brazil face regulatory hurdles but offer growth in palliative care[3].
• R&D shifts: 24 recent patents target non-opioid pathways for addiction, reflecting a pivot toward multi-receptor therapies[13].

While opioids remain irreplaceable for severe pain, the industry’s future hinges on mitigating public health risks through innovation and precision medicine.

References

1. https://www.precedenceresearch.com/opioids-market
2. https://pubmed.ncbi.nlm.nih.gov/28597483/
3. https://www.futuremarketinsights.com/reports/opioid-analgesics-market
4. https://www.ncbi.nlm.nih.gov/books/NBK459161/
5. https://www.cbsnews.com/news/oxycontin-maker-receives-patent-for-drug-to-treat-opioid-addiction/
6. https://www.researchandmarkets.com/reports/5806192/analgesics-market-analysis-drug-class-opioids
7. https://www.alliedmarketresearch.com/opioids-market
8. https://www.physiciansweekly.com/opioid-liglobal-patent-landscape-of-bph-drugs/
9. https://www.cassavasciences.com/news-releases/news-release-details/pain-therapeutics-expands-patent-portfolio-novel-pain
10. https://patents.google.com/patent/US9844516B2/en
11. https://www.pharmamanufacturing.com/home/article/55249347/key-drugs-losing-patent-protection-in-2025
12. https://avalere.com/press-releases/avalere-develops-report-on-opioid-analgesic-trends
13. https://pubmed.ncbi.nlm.nih.gov/39816001/
14. https://go.drugbank.com/drugs/DB00813
15. https://www.adial.com/adial-pharmaceuticals-awarded-new-u-s-patent-covering-genotype-specific-treatment-of-opioid-related-disorders/
16. https://journals.indexcopernicus.com/api/file/viewByFileId/1969266
17. https://www.globenewswire.com/news-release/2024/05/28/2888750/28124/en/Global-Opioid-Analgesic-Market-Forecast-2024-to-2030-Featuring-Profiles-of-Pfizer-Abbott-Laboratories-Janssen-Pharmaceuticals-Novartis-Bayer.html
18. https://www.snsinsider.com/reports/analgesics-market-1290