Opioid Agonist Drug Class List

Drugs in Drug Class: Opioid Agonist

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Elite Labs Inc	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	212418-002	Sep 10, 2019	AA	RX	No	No
Specgx Llc	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	040419-001	May 31, 2001	AA	RX	No	Yes
Specgx Llc	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	040419-002	May 31, 2001	AA	RX	No	Yes
Strides Pharma	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	089805-001	Sep 30, 1988	AA	RX	No	No

Opioid Agonist Market Analysis and Financial Projection

The opioid agonist market is shaped by evolving healthcare demands, regulatory pressures, and innovations in drug formulations. Below is an analysis of market dynamics and patent trends influencing this drug class.

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Market Dynamics

Growth Drivers

• Rising chronic pain prevalence: Over 20% of adults globally suffer from chronic pain, driving demand for opioid agonists like morphine and oxycodone[3][5].
• Aging populations: With 1 in 6 people aged 65+ by 2030, age-related conditions (e.g., osteoarthritis, cancer) are boosting opioid prescriptions[3][8].
• Abuse-deterrent formulations (ADFs): Companies like Elite Pharmaceuticals and Purdue Pharma dominate this $3.69 billion segment (2025), combining agonists with antagonists (e.g., naltrexone) to deter misuse[2][7][10].

Market Expansion

• The global opioid agonist market is projected to grow at a 3.24% CAGR, reaching $23.85 billion by 2028[8]. Key regions:
  • North America (63.6% share): High opioid consumption but facing stricter regulations[12].
  • Asia-Pacific: Emerging markets leverage low-cost manufacturing and rising healthcare access[3][14].

Challenges

• Opioid crisis: Prescription opioids account for 12% of fatal overdases (2023)[12]. Regulatory bodies like the CDC now cap daily doses at 90 morphine milligram equivalents[8].
• Generic competition: Patent expirations for blockbuster drugs (e.g., Symbicort, Farxiga) in 2025 will intensify price pressures[13][14].

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Patent Landscape

Key Innovations

1. Abuse-deterrent formulations (ADFs):

   • Elite Pharmaceuticals’ ART™ technology embeds naltrexone in multi-particulate beads to block euphoria if crushed[2].
   • Purdue Pharma’s oxycodone/naltrexone/acetaminophen combo (Patent 9,474,750) reduces overdose risks[7][10].

2. Personalized treatments:

   • Adial Pharmaceuticals’ genotype-specific therapy (2025 patent) targets the SLC6A4 gene in opioid-dependent patients[15].

Strategic Patent Expirations (2025)

Drug	Company	Impact
Symbicort	AstraZeneca	Generics to disrupt COPD/asthma markets
Farxiga	AstraZeneca	SGLT2 inhibitor competition intensifies
Imbruvica	AbbVie/J&J	Lower-cost blood cancer alternatives

Lifecycle Management

• Patent extensions: Novartis secured a European patent for Gilenya until 2028, delaying generics[14].
• New indications: Naltrexone, originally for addiction, now treats alcohol dependence and chronic pain[1][9].

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Future Outlook

The opioid agonist market faces a balancing act between innovation and risk mitigation. While ADFs and personalized therapies (e.g., Adial’s AD04) aim to curb misuse, generics entering post-2025 will reshape affordability. Regulatory focus on non-opioid alternatives (e.g., suzetrigine)[12] and Asia-Pacific’s growth (6.9% CAGR in China)[9] will define competitiveness.

“Abuse-deterrent opioid formulations are critical to address both therapeutic needs and public health crises.” – Research Nester Analysis[1].

Key stakeholders must prioritize R&D in safer pain management while navigating patent cliffs and evolving compliance mandates[5][14].

References

1. https://www.researchnester.com/reports/opioid-antagonist-market/3179
2. https://www.globenewswire.com/news-release/2015/06/16/745046/9233/en/Elite-Pharmaceuticals-Granted-New-Patent-for-Abuse-Deterrent-Technology.html
3. https://www.databridgemarketresearch.com/reports/global-opioid-receptor-agonist-market
4. https://www.ftc.gov/sites/default/files/documents/reports/generic-drug-entry-prior-patent-expiration-ftc-study/genericdrugstudy_0.pdf
5. https://www.gminsights.com/industry-analysis/pain-management-drugs-market
6. https://www.pharmiweb.com/press-release/2025-03-05/rising-opioid-addiction-drives-growth-in-the-global-opioid-use-disorder-treatment-market-share-analy
7. https://www.drugpatentwatch.com/p/patent/9474750
8. https://www.verifiedmarketresearch.com/product/opioids-agonist-drugs-market/
9. https://www.futuremarketinsights.com/reports/opioid-use-disorder-treatment-market
10. https://pubchem.ncbi.nlm.nih.gov/patent/US-2016051539-A1
11. https://www.grandviewresearch.com/industry-analysis/opioids-market
12. https://www.bipc.com/4-potential-fda-drug-approvals-to-watch-in-2025
13. https://biopharmaapac.com/analysis/60/5727/25-high-value-drugs-losing-patent-protection-in-2025-what-it-means-for-healthcare.html
14. https://www.alliedmarketresearch.com/patented-drugs-market-A110993
15. https://www.adial.com/adial-pharmaceuticals-awarded-new-u-s-patent-covering-genotype-specific-treatment-of-opioid-related-disorders/