Levorphanol tartrate - Generic Drug Details

What are the generic drug sources for levorphanol tartrate and what is the scope of freedom to operate?

Levorphanol tartrate is the generic ingredient in two branded drugs marketed by Valeant Pharm Intl, Acertis Pharms, Hikma, Novitium Pharma, Specgx Llc, and Sun Pharm Inds Inc, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for levorphanol tartrate. Seven suppliers are listed for this compound.

Summary for levorphanol tartrate

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	7
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	8
Drug Prices:	Drug price trends for levorphanol tartrate
What excipients (inactive ingredients) are in levorphanol tartrate?	levorphanol tartrate excipients list
DailyMed Link:	levorphanol tartrate at DailyMed

See drug prices for levorphanol tartrate

Pharmacology for levorphanol tartrate

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for levorphanol tartrate

Analgesics, Opioid

Narcotics

US Patents and Regulatory Information for levorphanol tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novitium Pharma	LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	213479-001	Jul 1, 2020	BX	RX	No	No
Valeant Pharm Intl	LEVO-DROMORAN	levorphanol tartrate	INJECTABLE;INJECTION	008719-001	Dec 19, 1991		DISCN	No	No
Novitium Pharma	LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	213479-002	Jan 12, 2021	BX	RX	No	No
Specgx Llc	LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	212024-001	Dec 13, 2019	AB	RX	No	No
Hikma	LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	074278-002	Jun 18, 2018		DISCN	No	No
Sun Pharm Inds Inc	LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	213906-002	Apr 25, 2023		RX	No	Yes
Hikma	LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	074278-003	Jun 18, 2018		DISCN	No	No

Levorphanol tartrate Market Analysis and Financial Projection

Last updated: February 6, 2026

What Are the Market Dynamics for Levorphanol Tartrate?

Levorphanol tartrate, a potent opioid analgesic, faces a complex market landscape influenced by regulatory, medical, and societal factors. Its therapeutic profile includes treatment for severe pain, especially in cancer and post-operative settings. But shifts in prescribing practices and legal controls shape its market potential.

Regulatory Environment:
The Drug Enforcement Administration classifies levorphanol as a Schedule II controlled substance, aligning with its high potential for abuse and addiction. Regulatory scrutiny and restrictions on prescribing limit wider adoption. Controlled substance monitoring programs (CSMPs) intensify oversight, discouraging off-label or extended use.

Medical Use and Prescribing Trends:
Despite efficacy in managing severe pain, the use of levorphanol has declined over recent decades. Physicians increasingly prefer drugs with a less restrictive profile, such as morphine or fentanyl. The limited availability of formulations and lack of diverse administration routes hinder broader utilization.

Market Competition:
Multiple opioids dominate the severe pain market, including morphine, oxycodone, fentanyl, and methadone. Levorphanol competes in a niche segment, facing limited supply and awareness among healthcare providers.

Supply Chain and Manufacturing:
Levorphanol is manufactured primarily by a few pharmaceutical firms. Manufacturing complexities, including strict handling procedures due to its controlled status, lead to supply constraints.

Patient and Societal Factors:
The opioid crisis has resulted in stricter prescribing guidelines globally, notably in the United States. Heightened public and governmental scrutiny impacts prescription rates. Alternative non-opioid therapies are increasingly favored, reducing demand.

What Is the Financial Trajectory for Levorphanol Tartrate?

The financial outlook for levorphanol remains subdued, with no recent significant product launches or expansion efforts.

Market Size and Revenue Data:
Estimates place the global market for opioid analgesics at approximately USD 25 billion (2022), but levorphanol's share is minimal, likely under USD 10 million annually. Its niche positioning leads to limited revenue streams for manufacturers.

Pricing Trends:
Levorphanol is priced higher per dose than common opioids but sees limited volume. The high cost and regulatory hurdles restrict uptake, keeping revenue modest.

Investment and R&D:
Pharmaceutical investment in levorphanol has declined, with almost no R&D activity dedicated to new formulations or delivery methods since the early 2000s. Companies prioritize developing non-opioid analgesics and abuse-deterrent formulations.

Market Growth Projections:
No significant growth is projected over the next five years without regulatory or formulation breakthroughs. The opioid market is projected to decline or stabilize, constrained by societal and legislative trends.

Legal and Policy Impact:
Stringent regulatory environments and societal pushback on opioids will likely suppress the financial viability of levorphanol, barring innovations that mitigate abuse potential.

How Do Regulatory and Medical Factors Compare for Levorphanol?

Factors	Impact on Market and Financial Trajectory
DEA Scheduling	Limits prescriptions to specialized settings, restricts distribution
Prescribing Trends	Decline due to safety concerns and availability of alternatives
Societal Attitudes	Increased restrictions in response to opioid epidemic, reducing demand
Formulation Availability	Limited formulations curb usage and therapeutic convenience
R&D Focus	Shift towards abuse-deterrent and non-opioid options reduces innovation

What Are the Principal Challenges and Opportunities?

Challenges:

• Heavy regulatory oversight constrains prescribing and distribution.
• Competition from other opioids with established supply chains and familiarity.
• Societal and legislative pressures erode market demand.
• Limited research investment restricts product innovation.

Opportunities:

• Development of abuse-deterrent formulations may improve regulatory acceptance.
• Potential niche use in specific pain management protocols.
• Possible reformulation to include alternative delivery systems; however, financial incentives remain limited.

Key Takeaways

Levorphanol tartrate's market presence diminishes primarily due to regulatory restrictions, societal pushback against opioids, and competition from more prevalent analgesics. Financial prospects remain limited absent significant formulation innovation or regulatory relaxations. Its narrow niche status and societal concerns about opioids restrain growth potential.

FAQs

1. What countries regulate levorphanol as a controlled substance?
   Most countries, including the US, Canada, and European nations, classify it as Schedule II or equivalent, reflecting its high abuse potential.

2. Are there ongoing efforts to develop new formulations of levorphanol?
   Current R&D activity is minimal; most efforts focus on non-opioid pain treatments.

3. How does levorphanol compare to other opioids in terms of abuse potential?
   Levorphanol has similar abuse risks as other potent opioids; its high potency increases risk of misuse.

4. Is levorphanol still widely prescribed?
   No, its prescriptions have declined significantly over the past two decades.

5. Could changes in opioid regulation favor levorphanol’s market?
   Possible if regulatory environments soften or if formulations demonstrate reduced abuse potential; currently unlikely.

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References

1. U.S. Drug Enforcement Administration. “Controlled Substances Schedules.” 2022.
2. IQVIA. “Opioid Market Overview.” 2022.
3. FDA. “Review of Opioid Analgesics.” 2021.
4. CDC. “Guidelines for Prescribing Opioids.” 2022.
5. Medscape. “Levorphanol Overview.” 2023.