DIETHYLPROPION HYDROCHLORIDE - Generic Drug Details

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

Diethylpropion hydrochloride is the generic ingredient in five branded drugs marketed by Lannett Co Inc, Sanofi Aventis Us, Nostrum Labs Inc, 3M, Avanthi Inc, Chartwell Rx, Epic Pharma Llc, Sandoz, Teva, Ucb Inc, and Watson Labs, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for diethylpropion hydrochloride. Eleven suppliers are listed for this compound.

Summary for DIETHYLPROPION HYDROCHLORIDE

US Patents:	0
Tradenames:	5
Applicants:	11
NDAs:	16
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	2
Patent Applications:	6,670
What excipients (inactive ingredients) are in DIETHYLPROPION HYDROCHLORIDE?	DIETHYLPROPION HYDROCHLORIDE excipients list
DailyMed Link:	DIETHYLPROPION HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DIETHYLPROPION HYDROCHLORIDE

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

Sponsor	Phase
GlaxoSmithKline
New River Pharmaceuticals	Phase 1/Phase 2

See all DIETHYLPROPION HYDROCHLORIDE clinical trials

Pharmacology for DIETHYLPROPION HYDROCHLORIDE

Drug Class	Sympathomimetic Amine Anorectic
Physiological Effect	Appetite Suppression Increased Sympathetic Activity

Medical Subject Heading (MeSH) Categories for DIETHYLPROPION HYDROCHLORIDE

Appetite Depressants

US Patents and Regulatory Information for DIETHYLPROPION HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	TENUATE	diethylpropion hydrochloride	TABLET;ORAL	017668-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Nostrum Labs Inc	TENUATE	diethylpropion hydrochloride	TABLET;ORAL	011722-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
3m	TEPANIL TEN-TAB	diethylpropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	017956-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	DIETHYLPROPION HYDROCHLORIDE	diethylpropion hydrochloride	TABLET;ORAL	085741-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Avanthi Inc	DIETHYLPROPION HYDROCHLORIDE	diethylpropion hydrochloride	TABLET;ORAL	201212-001	Dec 22, 2010	AA	RX	No	No
Lannett Co Inc	DIETHYLPROPION HYDROCHLORIDE	diethylpropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	091680-001	Oct 24, 2011		RX	No	Yes

DIETHYLPROPION HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diethylpropion Hydrochloride

Introduction

Diethylpropion hydrochloride, marketed under names such as Tenuate and Tenuate Dospan, is a sympathomimetic amine used in the management of exogenous obesity. Understanding its market dynamics and financial trajectory involves examining its clinical use, regulatory status, competition, and consumer response.

Clinical Use and Indications

Diethylpropion hydrochloride is indicated as a short-term adjunct in a regimen of weight reduction based on caloric restriction for patients with a BMI of 30 kg/m² or higher who have not responded to diet and/or exercise alone[1][2][3].

Pharmacology and Formulations

The drug is available in immediate-release and extended-release formulations. The extended-release tablets, such as Tenuate Dospan, release diethylpropion hydrochloride at a relatively uniform rate due to the slow hydration of a hydrophilic matrix. This controlled release results in more gradual plasma levels compared to immediate-release formulations[1][2][3].

Market Position

Diethylpropion hydrochloride has been on the market since its introduction in 1960. It competes in the antiobesity drug market, which includes other pharmacotherapeutic agents like orlistat, phentermine, and more recent entrants such as liraglutide and semaglutide.

Efficacy and Long-Term Use

Long-term studies have shown mixed results regarding the efficacy of diethylpropion hydrochloride. In some placebo-controlled trials, weight loss at 6- and 12-month follow-ups was less in drug-treated patients compared to placebo-treated patients[5]. This modest efficacy, combined with the short-term use indication, can impact its market share and financial performance.

Regulatory Status

Diethylpropion hydrochloride is a Schedule IV controlled substance due to its potential for abuse and dependence. This regulatory status can affect its prescribing patterns and patient access, influencing its market dynamics[2][3].

Competition and Market Share

The antiobesity drug market is competitive, with various drugs offering different mechanisms of action and efficacy profiles. The introduction of newer, more effective drugs can erode the market share of older drugs like diethylpropion hydrochloride. Additionally, the withdrawal of other drugs in the same therapeutic class can have spillover effects, either positively or negatively impacting the sales of remaining drugs[4].

Consumer Response and Safety Concerns

Consumer response to diethylpropion hydrochloride is influenced by its side effect profile, which includes central nervous system stimulation, elevation of blood pressure, and potential for dependence and withdrawal syndrome. Rare but serious adverse effects such as toxic psychosis and hallucinations can further impact consumer confidence and prescribing rates[2][3].

Financial Trajectory

The financial performance of diethylpropion hydrochloride is tied to its prescription volume, competition, and regulatory environment. Here are some key factors:

Prescription Volume

The prescription volume for diethylpropion hydrochloride has likely declined over the years due to the introduction of newer antiobesity drugs with better efficacy and safety profiles.

Pricing and Reimbursement

The pricing strategy for diethylpropion hydrochloride, including any changes in reimbursement policies by healthcare providers, can significantly impact its financial trajectory. Generic versions of the drug may also reduce the revenue generated by the branded product.

Regulatory Changes

Any changes in regulatory status, such as additional safety warnings or restrictions on use, can negatively impact sales. Conversely, favorable regulatory decisions can stabilize or improve its market position.

Market Trends

The overall trend in the antiobesity drug market is towards more effective and safer treatments. Diethylpropion hydrochloride, being an older drug with limited long-term efficacy, may see its market share decline as newer drugs gain approval and market acceptance.

Impact of Drug Withdrawals

The withdrawal of other drugs in the same therapeutic class can have mixed effects on diethylpropion hydrochloride. While it might gain some market share from patients switching from withdrawn drugs, negative spillovers due to consumer concerns about the safety of the entire class of drugs could also occur[4].

Key Takeaways

• Clinical Use: Diethylpropion hydrochloride is used as a short-term adjunct in weight reduction for patients with a BMI of 30 kg/m² or higher.
• Market Position: It competes in a crowded antiobesity drug market with newer, often more effective drugs.
• Efficacy: Long-term efficacy is modest, which can impact its market share.
• Regulatory Status: It is a Schedule IV controlled substance, affecting its prescribing and patient access.
• Consumer Response: Safety concerns and side effects influence consumer confidence.
• Financial Trajectory: Declining prescription volume, competition, and regulatory changes are key factors.

FAQs

1. What is diethylpropion hydrochloride used for? Diethylpropion hydrochloride is used in the management of exogenous obesity as a short-term adjunct in a regimen of weight reduction based on caloric restriction.

2. What are the different formulations of diethylpropion hydrochloride? It is available in immediate-release and extended-release (e.g., Tenuate Dospan) formulations.

3. How effective is diethylpropion hydrochloride in long-term weight loss? Long-term studies have shown mixed results, with some indicating less weight loss in drug-treated patients compared to placebo-treated patients.

4. Why is diethylpropion hydrochloride a controlled substance? It is classified as a Schedule IV controlled substance due to its potential for abuse and dependence.

5. How does the withdrawal of other antiobesity drugs affect diethylpropion hydrochloride? The impact can be mixed, with potential gains in market share from patients switching from withdrawn drugs, but also possible negative spillovers due to consumer safety concerns.

Sources

1. DailyMed - Diethylpropion Hydrochloride Extended Release Tablets https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dab53f4f-68d4-4477-a2b6-ad44a956332b

2. FDA Label - TENUATE IV (diethylpropion hydrochloride) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/11722s029,12546s032lbl.pdf

3. E-lactancia - Diethylpropion HCl USP CIV 25 mg Tablets https://www.e-lactancia.org/media/papers/Anfepramona-DS-UDS2011.pdf

4. NBER Working Paper - The Competitive Effects of Drug Withdrawals https://www.nber.org/system/files/working_papers/w11223/w11223.pdf

5. JAMA Internal Medicine - Long-term Pharmacotherapy of Obesity 2000: A Review of Efficacy https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/751590