Opioid Antagonist Drug Class List

Drugs in Drug Class: Opioid Antagonist

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	ALVIMOPAN	alvimopan	CAPSULE;ORAL	216843-001	Jan 24, 2023	AB	RX	No	No
Hikma	ALVIMOPAN	alvimopan	CAPSULE;ORAL	217753-001	Aug 31, 2023	AB	RX	No	No
Watson Labs Teva	ALVIMOPAN	alvimopan	CAPSULE;ORAL	208295-001	Dec 19, 2019	AB	RX	No	Yes

Opioid Antagonist Market Analysis and Financial Projection

The opioid antagonist market is undergoing rapid transformation driven by escalating demand due to the global opioid crisis, regulatory shifts, and pharmaceutical innovation. Here's a structured analysis of the market dynamics and patent landscape shaping this therapeutic class.

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Market Dynamics: Growth Drivers and Challenges

Market size and growth projections indicate robust expansion:

• Valued at $4.2 billion in 2022, the market is projected to reach $6.8 billion by 2030 (CAGR: 7.2%)[4]. Alternative estimates suggest even higher growth, with forecasts of $15.44 billion by 2037 (CAGR: 12.5%)[6].
• Naloxone, a frontline overdose-reversal agent, dominates sales due to widespread adoption in harm reduction programs. For example, U.S. states with naloxone distribution initiatives reported 75% increases in administrations by emergency services[6].

Key Growth Drivers

1. Opioid Overdose Epidemic: Over 70,000 U.S. overdose deaths in 2020 involved opioids[4], spurring demand for antagonists.
2. Regulatory Support: The FDA’s approval of intranasal naloxone formulations and state-level standing orders (e.g., Massachusetts, California) improved accessibility[1][3].
3. Technological Innovations: Next-gen formulations like auto-injectors and nasal sprays simplify administration, enabling broader community use[6][9].

Market Challenges

• Regulatory Complexity: Varying approval processes across regions delay drug launches[1].
• Stigma and Cost Barriers: Social stigma around addiction and limited insurance coverage hinder patient access[1][4].

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Patent Landscape: Innovation and Competition

The opioid antagonist sector is marked by strategic patent filings, litigation, and generic entry threats:

Key Patents and Innovations

Patent Holder	Innovation	Impact
Purdue Pharma	Combines opioid agonists/antagonists (e.g., Patent 9,474,750) to deter misuse[5][7].	Targets abuse-deterrent formulations, extending brand exclusivity.
Adapt Pharma (Teva)	Intra-nasal naloxone device (Narcan), invalidated in 2022 due to prior art obviousness[9][11].	Highlighted risks of relying on delivery-system patents.
Orexigen Therapeutics	Contrave (naltrexone/bupropion) for obesity, with exclusivity until 2028[10].	Expands antagonist applications beyond addiction treatment.

Generics and Patent Expirations

• TROXYCA ER (naltrexone/oxycodone) loses U.S. patent protection in July 2025, opening doors for generics[12].
• Naltrexone HCl faces competition as FDA exclusivity periods expire, with 19 drug master files already submitted[12].

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Strategic Shifts and Future Outlook

1. Diversified Applications: Naltrexone’s use in alcohol use disorder (13% of treatment programs) signals market expansion beyond opioid reversal[6].
2. Next-Gen Inhibitors: NaV1.8 inhibitors (e.g., VX-548) represent a novel pain-management frontier, with patents focusing on solubility and efficacy enhancements[2].
3. Public-Private Partnerships: Collaborations like the CDC’s naloxone distribution programs aim to address systemic barriers to access[1][4].

Quote:

“The development of user-friendly naloxone formulations has revolutionized overdose response, empowering laypersons to save lives.”[9]

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Conclusion

The opioid antagonist market is poised for sustained growth, driven by public health imperatives and pharmaceutical advancements. However, patent litigation risks and regulatory fragmentation necessitate agile strategies. Innovations in delivery systems and expanded therapeutic applications will likely define the next decade, while generics intensify price competition post-2025.

References

1. https://pmarketresearch.com/product/worldwide-reinforcement-learning-market-research-2024-by-type-application-participants-and-countries-forecast-to-2030/worldwide-opioid-antagonist-market-research-2024-by-type-application-participants-and-countries-forecast-to-2030
2. https://synapse.patsnap.com/blog/breakthrough-pain-relief-innovation-patent-exploration-of-next-generation-nav18-inhibitors
3. https://www.fda.gov/drugs/food-and-drug-administration-overdose-prevention-framework/timeline-selected-fda-activities-and-significant-events-addressing-substance-use-and-overdose
4. https://www.verifiedmarketreports.com/product/opiate-antagonist-market/
5. https://www.drugpatentwatch.com/p/patent/9474750
6. https://www.researchnester.com/reports/opioid-antagonist-market/3179
7. https://www.drugpatentwatch.com/p/patent/8673355
8. https://www.globenewswire.com/news-release/2024/12/02/2989499/28124/en/Opioid-Induced-Constipation-OIC-Therapeutics-Market-Forecast-2025-2030-by-Active-Ingredients-Drug-Class-Mode-of-Administration-Distribution-Channel-and-Region.html
9. https://www.sternekessler.com/news-insights/news/federal-circuit-tosses-naloxone-patents/
10. https://www.biospace.com/orexigen-therapeutics-inc-announces-allowance-of-new-u-s-patent-for-contrave-naltrexone-hcl-bupropion-hcl-extended-release
11. https://www.sternekessler.com/news-insights/news/split-fed-circ-wont-restore-4-narcan-patents/
12. https://www.drugpatentwatch.com/p/generic-entry-opportunity-date/
13. https://www.futuremarketinsights.com/reports/opioid-analgesics-market