PHENTERMINE HYDROCHLORIDE - Generic Drug Details

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

Phentermine hydrochloride is the generic ingredient in twelve branded drugs marketed by Teva, Glaxosmithkline, Ferndale Labs, Shire Richwood, Mast Mm, Abc Holding, Able, Aurolife Pharma Llc, Barr, Camall, Chartwell Rx, Duramed Pharms Barr, Elite Labs, Elite Labs Inc, Invagen Pharms, Ivax Pharms, Kvk Tech, Lannett, Lannett Co Inc, Nuvo Pharm, Sandoz, Sun Pharm Industries, Tg United Inc, Upsher Smith Labs, Usl Pharma, Vitarine, Watson Labs, Zydus Pharms, Citius Pharms, Avanthi Inc, Actavis Elizabeth, Aurobindo Pharma Ltd, Kvk Tech Inc, Merro Pharm Usa, Novast Labs, Prinston Inc, Sandoz Inc, Sun Pharm Inds Inc, Solvay, Actavis Labs Fl Inc, and Vivus Llc, and is included in one hundred and one NDAs. There are seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Phentermine hydrochloride has two patent family members in two countries.

There are eight drug master file entries for phentermine hydrochloride. Thirty-two suppliers are listed for this compound.

Summary for PHENTERMINE HYDROCHLORIDE

International Patents:	2
US Patents:	7
Tradenames:	12
Applicants:	41
NDAs:	101
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	32
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	47
Patent Applications:	1,403
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PHENTERMINE HYDROCHLORIDE
What excipients (inactive ingredients) are in PHENTERMINE HYDROCHLORIDE?	PHENTERMINE HYDROCHLORIDE excipients list
DailyMed Link:	PHENTERMINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PHENTERMINE HYDROCHLORIDE

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
Biomedical Research Institute of New Mexico	Phase 4
National Heart, Lung, and Blood Institute (NHLBI)	Phase 4

See all PHENTERMINE HYDROCHLORIDE clinical trials

Pharmacology for PHENTERMINE HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for PHENTERMINE HYDROCHLORIDE

A08AA	Centrally acting antiobesity products
A08A	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A08	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for PHENTERMINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUPRENZA	Orally Disintegrating Tablets	phentermine hydrochloride	37.5 mg	202088	1	2013-03-22
SUPRENZA	Orally Disintegrating Tablets	phentermine hydrochloride	15 mg and 30 mg	202088	1	2012-10-19

US Patents and Regulatory Information for PHENTERMINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	AB	RX	Yes	No	8,895,057
Camall	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	086735-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012	AB	RX	Yes	No
Sun Pharm Inds Inc	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	TABLET;ORAL	040790-001	Aug 21, 2007		DISCN	No	No

Expired US Patents for PHENTERMINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-001	Jun 13, 2011	6,149,938
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-003	Mar 27, 2012	6,149,938
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-002	Jun 13, 2011	6,149,938

International Patents for PHENTERMINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2254558	COMPRIMÉS À DISSOLUTION ORALE AYANT UN ASPECT MOUCHETÉ (ORALLY DISINTEGRATING TABLETS WITH SPECKLED APPEARANCE)
World Intellectual Property Organization (WIPO)	2009098169

Supplementary Protection Certificates for PHENTERMINE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2317997	2190050-1	Sweden		PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212

PHENTERMINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Phentermine Hydrochloride

Introduction

Phentermine hydrochloride, a sympathomimetic amine anorectic agent, has been a significant player in the weight loss market since its introduction in 1959. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its current status, growth prospects, and key factors influencing its market performance.

Market Size and Growth Prospects

The phentermine hydrochloride market is anticipated to exhibit robust growth in the coming years. By 2031, the market is expected to reach a value of USD 567.86 million, driven by a Compound Annual Growth Rate (CAGR) of 6.30%[1][4].

Driving Factors

Several factors are driving the growth of the phentermine hydrochloride market:

Increasing Obesity

The global rise in obesity rates is a significant driver. With over two-thirds of adults in the United States being overweight or obese, the demand for effective weight loss treatments is on the rise[3].

E-Commerce and D2C Channels

The expansion of e-commerce and direct-to-consumer (D2C) channels has made phentermine hydrochloride more accessible to a broader audience, contributing to market growth[1].

Combination Therapies

The efficacy of phentermine hydrochloride when combined with other drugs, such as topiramate, has been a key factor. These combination therapies have shown significant weight loss results in clinical trials, further boosting market demand[2].

Market Segmentation

The phentermine hydrochloride market is segmented based on type and application:

Type

• Capsules
• Tablets

Application

• Hospitals
• Clinics
• Other healthcare facilities[1].

Pharmacology and Mechanism of Action

Phentermine hydrochloride works by suppressing appetite and increasing resting energy expenditure. It is indicated for short-term use in a regimen of weight reduction, based on exercise, behavioral modifications, and caloric restriction, for patients with a BMI greater than 30 kg/m² or greater than 27 kg/m² with other risk factors such as controlled hypertension, diabetes, or hyperlipidemia[3].

Clinical Efficacy

Clinical studies have shown that phentermine hydrochloride, both as monotherapy and in combination with topiramate, results in significant weight loss. Patients treated with phentermine hydrochloride have shown an average weight loss of 3.6 kg compared to placebo over 2-24 weeks[3].

Safety and Adverse Effects

While phentermine hydrochloride is generally well-tolerated, it can have adverse effects such as dermatoses, insomnia, irritability, and hyperactivity. Severe cases can lead to schizophrenia-like psychosis. However, it does not produce the typical effects of amphetamines, such as central nervous system stimulation or QTc prolongation[3].

Pharmacokinetics

Phentermine hydrochloride is excreted mainly in the urine, with about 70-80% of the administered dose found as the unchanged drug. It has a mean terminal half-life of approximately 20 hours, which can be shorter in cases of acidic urine[3].

Market Challenges

Despite the growth prospects, the market faces some challenges:

Side Effects

Serious side effects, such as metabolic acidosis, psychiatric, cognitive, and psychomotor adverse events associated with combination therapies (e.g., with topiramate), can restrict market growth[2].

Regulatory Scrutiny

Phentermine hydrochloride, being a controlled substance, is subject to regulatory scrutiny, which can impact its availability and marketing[3].

Financial Performance

The financial performance of the phentermine hydrochloride market is influenced by several factors, including the cost of the drug, market competition, and regulatory approvals.

Pricing

The cost of phentermine hydrochloride varies based on the formulation and dosage. For example, Adipex-P 37.5 mg capsules can range from $1.0 to $2.2 per capsule[3].

Revenue Projections

With a projected CAGR of 6.30%, the market is expected to generate significant revenue. The anticipated market value of USD 567.86 million by 2031 underscores the financial potential of this drug[1].

Key Players and Competitive Landscape

The market for phentermine hydrochloride is competitive, with several key players involved in its manufacture and distribution. Companies are focusing on improving formulations, such as extended-release capsules, and expanding their distribution channels to capture a larger market share[4].

Future Outlook

The future outlook for the phentermine hydrochloride market is positive, driven by increasing demand for weight loss treatments and the efficacy of combination therapies. However, addressing the challenges related to side effects and regulatory scrutiny will be crucial for sustained growth.

"Phentermine hydrochloride, when used in combination with topiramate, has shown significant weight loss results in clinical trials, making it a promising treatment option for obesity management"[2].

Key Takeaways

• The phentermine hydrochloride market is expected to reach USD 567.86 million by 2031, with a CAGR of 6.30%.
• Increasing obesity rates and the expansion of e-commerce channels are driving market growth.
• The drug is effective in combination therapies, particularly with topiramate.
• Safety and regulatory challenges need to be addressed to ensure sustained market growth.
• The competitive landscape is characterized by multiple key players focusing on improved formulations and distribution.

Frequently Asked Questions (FAQs)

Q: What is the expected market value of phentermine hydrochloride by 2031? A: The phentermine hydrochloride market is expected to reach USD 567.86 million by 2031[1].

Q: What is the CAGR of the phentermine hydrochloride market? A: The phentermine hydrochloride market is expected to exhibit a CAGR of 6.30% by 2031[1].

Q: What are the primary driving factors of the phentermine hydrochloride market? A: Increasing obesity rates and the expansion of e-commerce and D2C channels are primary driving factors[1].

Q: How does phentermine hydrochloride work? A: Phentermine hydrochloride works by suppressing appetite and increasing resting energy expenditure[3].

Q: What are the common adverse effects of phentermine hydrochloride? A: Common adverse effects include dermatoses, insomnia, irritability, and hyperactivity. Severe cases can lead to schizophrenia-like psychosis[3].

Sources:

1. Global Phentermine Hydrochloride Market Research Report 2024 - Proficient Market Insights
2. Phentermine HCl (ADIPEX-P®) Clinical Pharmacology Review - FDA
3. Phentermine: Uses, Interactions, Mechanism of Action - DrugBank
4. Phentermine Hydrochloride Market Size, Scope And Forecast Report - Market Research Intellect