SECOBARBITAL SODIUM - Generic Drug Details

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

Secobarbital sodium is the generic ingredient in two branded drugs marketed by Anabolic, Barr, Everylife, Halsey, Ivax Pharms, Kv Pharm, Lannett, Parke Davis, Perrigo, Purepac Pharm, Valeant Pharm Intl, Vitarine, Watson Labs, West Ward, Whiteworth Town Plsn, Wyeth Ayerst, Valeant Pharms North, Elkins Sinn, and Lilly, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for secobarbital sodium.

Summary for SECOBARBITAL SODIUM

US Patents:	0
Tradenames:	2
Applicants:	19
NDAs:	23
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	1
Patent Applications:	193
DailyMed Link:	SECOBARBITAL SODIUM at DailyMed

Recent Clinical Trials for SECOBARBITAL SODIUM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all SECOBARBITAL SODIUM clinical trials

Medical Subject Heading (MeSH) Categories for SECOBARBITAL SODIUM

Adjuvants, Anesthesia

GABA Modulators

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for SECOBARBITAL SODIUM

N05CA	Barbiturates, plain
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

N05CA	Barbiturates, plain
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for SECOBARBITAL SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	SECOBARBITAL SODIUM	secobarbital sodium	CAPSULE;ORAL	085792-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Vitarine	SECOBARBITAL SODIUM	secobarbital sodium	CAPSULE;ORAL	086273-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Halsey	SECOBARBITAL SODIUM	secobarbital sodium	CAPSULE;ORAL	084676-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Elkins Sinn	SECOBARBITAL SODIUM	secobarbital sodium	INJECTABLE;INJECTION	083281-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Vitarine	SECOBARBITAL SODIUM	secobarbital sodium	CAPSULE;ORAL	085898-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	SECONAL SODIUM	secobarbital sodium	SUPPOSITORY;RECTAL	086530-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Wyeth Ayerst	SECOBARBITAL SODIUM	secobarbital sodium	CAPSULE;ORAL	086390-001	Approved Prior to Jan 1, 1982		DISCN	No	No

SECOBARBITAL SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Secobarbital Sodium

Introduction

Secobarbital sodium, marketed under brand names such as Seconal and Tuinal, is a barbiturate derivative with anaesthetic, anticonvulsant, sedative, and hypnotic properties. This article will delve into the market dynamics and financial trajectory of secobarbital sodium, providing insights into its historical use, current market status, and financial aspects.

Historical Use and Market Entry

Secobarbital sodium was first introduced by Eli Lilly and Company in the mid-20th century. It was widely prescribed for the short-term treatment of insomnia and as a sedative before surgery[3][4].

Brand Names and Formulations

Secobarbital sodium is available under several brand names, including Seconal and Tuinal. These formulations often combine secobarbital with other barbiturates, such as amobarbital, to enhance their sedative effects[3].

Market Dynamics

Therapeutic Uses

Secobarbital sodium is primarily used for the short-term treatment of insomnia and as a pre-anesthetic sedative. However, its use has declined significantly due to the development of safer and more effective alternatives, such as benzodiazepines and non-benzodiazepine hypnotics[1][4].

Competition and Alternatives

The market for sedatives and hypnotics has become highly competitive, with numerous alternatives available. Benzodiazepines and non-benzodiazepine hypnotics have gained preference due to their lower risk of dependence and overdose compared to barbiturates[1].

Regulatory Environment

The use of barbiturates, including secobarbital sodium, is heavily regulated due to their potential for abuse and overdose. This regulatory scrutiny has impacted their market availability and prescribing practices[4].

Financial Trajectory

Pricing and Cost

The pricing of secobarbital sodium varies depending on the formulation and dosage. For example, a 100 mg capsule of Seconal sodium can cost around $4.91 per capsule, while a 100 mg pulvule can cost approximately $0.93 each[3].

Revenue Trends

Historically, secobarbital sodium generated significant revenue due to its widespread use in the mid-20th century. However, with the decline in prescriptions and the introduction of safer alternatives, the revenue from secobarbital sodium has substantially decreased.

Impact of Generic Competition

The availability of generic versions of secobarbital sodium has further reduced its market value. Generic competition often leads to lower prices, which can erode the revenue of branded products[3].

Interactions and Dosage Adjustments

The financial trajectory of secobarbital sodium is also influenced by its interactions with other medications. For instance, when used concurrently with phenytoin, sodium valproate, or valproic acid, close monitoring and dosage adjustments are necessary, which can affect treatment costs and patient compliance[1][4].

Market Exit and Discontinuation

Several formulations of secobarbital sodium, such as Tuinal Pulvule 303 and 304, have been discontinued since 2004. This discontinuation reflects the declining demand and the shift towards safer therapeutic options[3].

Current Market Status

As of the current date, secobarbital sodium is no longer a dominant player in the market for sedatives and hypnotics. Its use is largely limited to specific clinical scenarios where other options are not suitable, and it is often prescribed with caution due to its potential for abuse and dependence.

Key Takeaways

• Historical Significance: Secobarbital sodium was once widely used for insomnia and pre-anesthetic sedation.
• Declining Use: Its use has declined due to the introduction of safer alternatives.
• Regulatory Scrutiny: Heavily regulated due to potential for abuse and overdose.
• Financial Impact: Revenue has decreased significantly due to generic competition and declining prescriptions.
• Current Status: Limited to specific clinical scenarios where other options are not suitable.

FAQs

What is secobarbital sodium used for?

Secobarbital sodium is used for the short-term treatment of insomnia and as a sedative before surgery.

Why has the use of secobarbital sodium declined?

The use of secobarbital sodium has declined due to the development of safer and more effective alternatives, such as benzodiazepines and non-benzodiazepine hypnotics.

How does secobarbital sodium interact with other medications?

Secobarbital sodium can interact with medications like phenytoin, sodium valproate, and valproic acid, requiring close monitoring and dosage adjustments.

Is secobarbital sodium still widely prescribed?

No, secobarbital sodium is no longer widely prescribed due to its potential for abuse and the availability of safer alternatives.

What are the current market trends for secobarbital sodium?

The current market trends indicate a significant decline in the use and revenue of secobarbital sodium, with its use limited to specific clinical scenarios.

Sources

1. DailyMed: Seconal Sodium (Secobarbital Sodium Capsules, USP)[1].
2. Physiology.org: Annual Meeting of the IUPS Commission on Gravitational Physiology[2].
3. DrugBank: Secobarbital: Uses, Interactions, Mechanism of Action[3].
4. RxList: Seconal Sodium (Secobarbital Sodium Capsules)[4].
5. GovInfo: Federal Register[5].