STADOL Drug Patent Profile

When do Stadol patents expire, and when can generic versions of Stadol launch?

Stadol is a drug marketed by Apothecon and Bristol Myers Squibb and is included in two NDAs.

The generic ingredient in STADOL is butorphanol tartrate. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the butorphanol tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Stadol

A generic version of STADOL was approved as butorphanol tartrate by HIKMA on August 12^th, 1998.

Summary for STADOL

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	16
Patent Applications:	1,476
DailyMed Link:	STADOL at DailyMed

US Patents and Regulatory Information for STADOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apothecon	STADOL	butorphanol tartrate	INJECTABLE;INJECTION	017857-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Bristol Myers Squibb	STADOL	butorphanol tartrate	SPRAY, METERED;NASAL	019890-001	Dec 12, 1991		DISCN	No	No
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for STADOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	STADOL	butorphanol tartrate	SPRAY, METERED;NASAL	019890-001	Dec 12, 1991	4,464,378

International Patents for STADOL

See the table below for patents covering STADOL around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	141624
Canada	999578	14-HYDROXYMORPHINAN DERIVATIVES
United Kingdom	1412129
Australia	8524782
Ireland	36688	3-SUBSTITUTED-MORPHINAN DERIVATIVES

STADOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: STADOL

Introduction

STADOL, also known as butorphanol tartrate, is a synthetically derived opioid agonist-antagonist analgesic commonly used for pain relief, particularly for migraines and labor pains. This article delves into the market dynamics and financial trajectory of STADOL, examining its prescribing trends, financial impacts, and the broader market context.

Historical Context and Approval

STADOL was approved by the FDA and has been available in various forms, including injectable and nasal spray formulations. The drug's chemical name is (-)-17-(cyclobutylmethyl) morphinan-3, 14-diol [S- (R,R)] - 2,3 - dihydroxybutanedioate (1:1) (salt), and it is classified as a Schedule IV controlled substance due to its potential for abuse and dependence[4][5].

Prescribing Trends

Usage and Administration

STADOL is prescribed for several medical conditions, including migraine relief and labor pains. The nasal spray is a popular form due to its ease of administration and rapid onset of action. The recommended dosing ranges vary depending on the route of administration, with intravenous and intramuscular injections typically used in clinical settings and the nasal spray often used for outpatient care[2][4].

Patient Demographics

The use of STADOL has seen variations in patient demographics over the years. While it is commonly prescribed for various age groups, its use has been more prevalent among women, particularly for labor pains. The drug's effectiveness in women is noted to be higher compared to men in some studies[2].

Financial Impact

Revenue and Market Share

The financial performance of STADOL is influenced by several factors, including prescribing rates, competition from other analgesics, and regulatory changes. While specific revenue figures for STADOL are not readily available, the overall market for opioid analgesics has been significant. However, the market share of STADOL has likely been impacted by the increasing scrutiny and regulatory measures surrounding opioid use and abuse[2][3].

Impact of Regulatory Changes

Regulatory actions and changes in prescribing guidelines can significantly affect the financial trajectory of pharmaceuticals. For instance, the classification of STADOL as a Schedule IV controlled substance reflects its potential for abuse, which can limit its prescribing and thus impact revenue. Additionally, any adverse events or safety concerns, similar to those seen with other opioids, could lead to a decline in prescriptions and revenue[2][4].

Market Dynamics

Competition and Alternatives

The market for analgesics is highly competitive, with numerous alternatives available, including other opioids and non-opioid pain relievers. STADOL competes with drugs like meperidine and other opioid agonist-antagonists. The competitive landscape is further complicated by the introduction of new pain management therapies and the shifting preferences of healthcare providers and patients towards safer, less addictive options[3][5].

Impact of Drug Withdrawals

The pharmaceutical industry has seen several high-profile drug withdrawals due to safety concerns, which can have significant financial and market impacts. While STADOL has not been withdrawn from the market, the lessons from other drug withdrawals, such as Vioxx, highlight the potential financial and reputational risks associated with safety issues. For example, Merck's withdrawal of Vioxx led to a significant drop in stock price and massive legal liabilities[3].

Abuse and Misuse

Addiction and Dependence

STADOL's potential for abuse and dependence is a critical factor in its market dynamics. The drug's misuse, particularly through the nasal spray form, has been documented. This has led to increased regulatory scrutiny and public health concerns, which can affect prescribing rates and overall revenue. Medically-supervised detox programs are often necessary for patients who develop dependence on STADOL[2][4].

Pharmacokinetics and Pharmacodynamics

Absorption and Metabolism

The pharmacokinetics of STADOL vary depending on the route of administration. The nasal spray has a mean peak plasma concentration within 30-60 minutes, while intravenous and intramuscular injections have rapid absorption rates. The drug is extensively metabolized in the liver, and its bioavailability is affected by first-pass metabolism[4][5].

Financial Trajectory

Revenue Fluctuations

The revenue generated by STADOL has likely fluctuated over the years due to changes in prescribing patterns, competition, and regulatory environments. While specific financial data is not available, the overall trend in opioid prescriptions has seen declines in recent years due to increased awareness of opioid abuse and stricter prescribing guidelines.

Legal and Regulatory Costs

Companies manufacturing opioids, including STADOL, often face significant legal and regulatory costs. These can include litigation expenses related to abuse and misuse, as well as costs associated with complying with stricter regulatory requirements. These costs can significantly impact the financial trajectory of the drug[2][3].

Conclusion

The market dynamics and financial trajectory of STADOL are complex and influenced by a variety of factors, including prescribing trends, regulatory changes, competition, and public health concerns. As the pharmaceutical landscape continues to evolve, with a greater focus on safety and reduced opioid use, the future financial performance of STADOL will likely be shaped by these dynamics.

Key Takeaways

• STADOL is a synthetically derived opioid agonist-antagonist used for pain relief.
• The drug is available in injectable and nasal spray forms.
• Prescribing trends show higher use among women and varying demographics.
• Regulatory changes and safety concerns significantly impact revenue.
• The drug competes in a highly competitive analgesic market.
• Abuse and dependence are significant public health concerns.
• Pharmacokinetics vary by administration route.
• Financial trajectory is influenced by legal, regulatory, and market factors.

FAQs

What is STADOL used for?

STADOL, or butorphanol tartrate, is used for pain relief, particularly for migraines and labor pains.

Why is STADOL classified as a controlled substance?

STADOL is classified as a Schedule IV controlled substance due to its potential for abuse and dependence.

How does the nasal spray form of STADOL compare to injectable forms?

The nasal spray form of STADOL has a rapid onset of action, with peak plasma concentrations within 30-60 minutes, similar to injectable forms but with the convenience of outpatient use.

What are the risks associated with long-term use of STADOL?

Long-term use of STADOL can lead to tolerance and addiction, necessitating medically-supervised detox programs in some cases.

How has the opioid crisis impacted the market for STADOL?

The opioid crisis has led to increased regulatory scrutiny and public health concerns, affecting prescribing rates and overall revenue for STADOL.

Sources

1. IQVIA Report on Stimulant Trends from 2012 - 2022. U.S. Department of Justice.
2. Stadol Addiction - WAISMANN METHOD®. Opiates.com.
3. A Study of Prescription Drug Withdrawals. University of Georgia.
4. STADOL: Package Insert / Prescribing Information. Drugs.com.
5. STADOL® (butorphanol tartrate) Injection, USP STADOL NS® (butorphanol tartrate) Nasal Spray. FDA.