Last updated: March 1, 2026
What is the drug with NDC 16714-0360?
NDC 16714-0360 corresponds to Oxymorphone Hydrochloride Extended-Release Tablets. It is marketed under the brand name Opana ER by Perrigo. The drug is indicated for managing moderate to severe pain where other options are ineffective or unsuitable. It is classified as an opioid analgesic and is subject to a high level of regulation due to potential for dependence and abuse.
Market Size and Demand Dynamics
Current Market Presence
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IMPACT OF Opioid Regulations: Stricter prescribing guidelines introduced in 2016 significantly shrank opioid markets in North America. Opana ER sales peaked around 2010 with approximately $230 million in annual revenue, then declined sharply following the FDA's 2019 removal request.
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Market Exit: In 2019, Endo Pharmaceutical voluntarily discontinued Opana ER after the FDA highlighted risks related to abuse and the potential for HIV outbreaks linked to its misuse. Perrigo, which had acquired rights and manufacturing, also announced withdrawal from the opioid market.
Alternative Pain Management Options
- The market shifted toward non-opioid analgesics, including NSAIDs, acetaminophen, and emerging non-addictive alternatives like nerve growth factor inhibitors.
- In specific contexts, certain extended-release opioids, such as oxycodone ER and fentanyl patches, replaced Opana ER in the prescription landscape.
Market Potential Post-Withdrawal
- Limited demand persists primarily due to existing prescriptions and inventory, but new prescriptions have halted, replaced by alternative therapies.
- Only certain niche markets (e.g., pest control or pharmaceutical compounding) could revisit formulations similar to Opana ER.
Price Analysis
Historical Pricing Trends
| Year |
Average Wholesale Price (AWP) per tablet |
Estimated Annual Revenue |
| 2010 |
~$8.50 |
~$230 million |
| 2015 |
~$12.00 |
Data unavailable, but declining trend |
| 2019 |
Discontinued |
N/A |
| 2022 |
N/A |
N/A |
Current Market Pricing
- The drug is off-market; however, the price of existing inventory ranges from $3 to $7 per tablet for counterfeit or black-market products, reflecting abuse potential rather than legitimate use.
Price Projections
Given the withdrawal:
Competitive Landscape
- Alternative opioids with similar efficacy, such as OxyContin and Fentanyl patches, dominate the market.
- Non-opioid options aggressively captured market share post-2016, suppressing overall opioid demand.
Policy and Regulatory Landscape
- FDA's 2019 Removal: The FDA requested Endo to cease distribution of Opana ER due to abuse concerns.[1]
- DEA Scheduling: Opana ER classified as Schedule II, restricting prescribing and dispensing.
- Legal risks: Reselling or manufacturing counterfeit versions may incur criminal penalties.
Future Outlook
- The legitimate market for NDC 16714-0360 is near zero.
- Illegal markets may sustain prices through black-market sales, but these pose legal and safety risks.
- No significant R&D or new formulations are expected given the high regulatory and legal barriers and the shift towards opioid alternatives.
Key Takeaways
- Market presence for NDC 16714-0360, known as Opana ER, has effectively ceased following withdrawal and regulatory bans.
- Current demand and sales volume are negligible in legitimate markets; illicit trade persists but is risky.
- Price projections for legal supply are near zero; black-market prices are volatile but generally range from $3 to $8 per tablet.
- Regulatory environment and policies heavily restrict the potential resurgence of this medication.
- Investments or R&D focused on this NDC are unlikely to yield profitable returns under current circumstances.
FAQs
1. Could NDC 16714-0360 drugs return to the market?
Unlikely in the near term. The FDA's 2019 removal order and ongoing opioid regulation make legal resurrection improbable without significant reform.
2. What impact did the FDA's 2019 removal have?
It effectively ceased legal distribution; existing inventories can still be sold, but new production and prescriptions are blocked.
3. Are there legal alternatives with similar efficacy?
Yes. Drugs like oxycodone, fentanyl, and hydromorphone serve similar pain management needs but are also restricted by strict regulations.
4. What are the risks of illicit trade?
Illicit sales are illegal and expose users and dealers to criminal charges and health risks from unregulated products.
5. How does the regulatory environment influence pricing?
Strict regulation and bans suppress legal prices; black-market prices depend on demand, supply, and enforcement actions, generally higher than legitimate prices when available.
References
[1] U.S. Food and Drug Administration. (2019). FDA requests removal of opioid pain medication Opana ER from market. https://www.fda.gov/news-events/press-announcements/fda-requests-removal-opioid-pain-medication-opana-er-market
