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
Actavis Labs Fl Inc	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202144-002	May 12, 2014		DISCN	No	No
Aurobindo Pharma Ltd	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204421-001	Oct 20, 2015		DISCN	No	No
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-003	May 23, 2023		RX	Yes	No			Y
Mayne Pharma	FENTANYL-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077062-002	Aug 20, 2007		DISCN	No	No
Nortec Dev Assoc	MORPHINE SULFATE	morphine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	203158-003	Aug 4, 2021		DISCN	No	No
Watson Labs	SUFENTANIL CITRATE	sufentanil citrate	INJECTABLE;INJECTION	074406-001	Dec 15, 1995		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