PHENDIMETRAZINE TARTRATE - Generic Drug Details

What are the generic sources for phendimetrazine tartrate and what is the scope of patent protection?

Phendimetrazine tartrate is the generic ingredient in nineteen branded drugs marketed by Valeant, Numark, Graham Dm, Virtus, Shire Richwood, Mast Mm, Sandoz, Vitarine, Solvay, Teva, Ferndale Labs, Abc Holding, Camall, Chartwell Rx, Pvt Form, Forest Pharms, Barr, Chartwell, Elite Labs Inc, Inwood Labs, Ivax Pharms, Ivax Sub Teva Pharms, Kv Pharm, Kvk Tech, Mfg Chemists, Nexgen Pharma Inc, Nostrum Labs Inc, Upsher Smith Labs, Usl Pharma, Watson Labs, and Wyeth Ayerst, and is included in ninety-six NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for phendimetrazine tartrate. Twelve suppliers are listed for this compound.

Summary for PHENDIMETRAZINE TARTRATE

US Patents:	0
Tradenames:	19
Applicants:	31
NDAs:	96
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	21
Patent Applications:	2,768
Drug Prices:	Drug price trends for PHENDIMETRAZINE TARTRATE
What excipients (inactive ingredients) are in PHENDIMETRAZINE TARTRATE?	PHENDIMETRAZINE TARTRATE excipients list
DailyMed Link:	PHENDIMETRAZINE TARTRATE at DailyMed

See drug prices for PHENDIMETRAZINE TARTRATE

Pharmacology for PHENDIMETRAZINE TARTRATE

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

US Patents and Regulatory Information for PHENDIMETRAZINE TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mast Mm	PHENAZINE	phendimetrazine tartrate	CAPSULE;ORAL	086525-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Teva	STATOBEX	phendimetrazine tartrate	TABLET;ORAL	086013-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pvt Form	PHENDIMETRAZINE TARTRATE	phendimetrazine tartrate	TABLET;ORAL	085199-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Kv Pharm	PHENDIMETRAZINE TARTRATE	phendimetrazine tartrate	TABLET;ORAL	085525-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Nostrum Labs Inc	PHENDIMETRAZINE TARTRATE	phendimetrazine tartrate	TABLET;ORAL	203600-001	Dec 27, 2017		DISCN	No	No

PHENDIMETRAZINE TARTRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Phendimetrazine Tartrate

Introduction to Phendimetrazine Tartrate

Phendimetrazine tartrate is a phenylalkylamine sympathomimetic amine used in the management of exogenous obesity. It is classified as a Schedule III controlled substance due to its potential for abuse and dependence, similar to other anorectic agents like amphetamines[5].

Market Size and Growth Projections

The Phendimetrazine Tartrate Market has been experiencing significant growth in recent years. As of 2024, the market size was valued at USD 371.24 million. Projections indicate that this market is expected to reach USD 497.50 million by 2031, exhibiting a Compound Annual Growth Rate (CAGR) of 5.00% during this period[1][2].

Driving Factors

The primary drivers behind the growth of the Phendimetrazine Tartrate Market include:

• Obesity Epidemic: The rising prevalence of obesity globally has increased the demand for weight loss medications, including phendimetrazine tartrate.
• Health Consciousness: Growing awareness about health and wellness, particularly among individuals with a high body mass index (BMI), has driven the use of such medications[1][2].

Market Segmentation

The Phendimetrazine Tartrate Market is segmented based on several key factors:

• Type: The market is categorized into tablets and capsules. The tablets, such as the 35mg immediate-release form, and the extended-release capsules are the primary product types[2][4].
• Application: The market is segmented into hospitals and clinics, reflecting the primary settings where these medications are prescribed and administered[1][2].

Geographical Segmentation

The market is also segmented geographically into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own market dynamics influenced by local healthcare policies, regulatory environments, and consumer behavior[2].

Competitive Landscape

The Phendimetrazine Tartrate Market is characterized by a mix of established and emerging players. Key companies profiled in the market include Nostrum Lab, KVK Tech, Bausch Health, Takeda Pharma, Virtus Pharma, Ferndale Pharma Group, Teva, Chartwell Pharma, Sandoz, and Shire. These companies are involved in the manufacturing, distribution, and marketing of phendimetrazine tartrate products[2].

Product Approvals and Regulatory Environment

Recent regulatory approvals have played a crucial role in shaping the market. For instance, Elite Pharmaceuticals received FDA approval for its abbreviated new drug application (ANDA) for Phendimetrazine Tartrate Tablets USP, 35mg, in January 2018. This approval has enabled the company to expand its product offerings and strategic options, including potential divestiture[3].

Market Dynamics: Drivers, Restraints, Opportunities, and Challenges

Drivers

• The increasing obesity epidemic and the need for effective weight loss treatments are driving the demand for phendimetrazine tartrate.
• Advances in pharmaceutical technology and the development of extended-release formulations have improved the efficacy and patient compliance of these medications[2].

Restraints

• The potential for abuse and dependence, as well as serious side effects such as pulmonary hypertension and valvular heart disease, pose significant restraints on the market. These risks necessitate careful patient evaluation and monitoring[5].

Opportunities

• Growing health consciousness and the expanding healthcare infrastructure in emerging markets present opportunities for market growth.
• Collaborations and licensing agreements among pharmaceutical companies can reduce development costs and improve cash flow, further driving market expansion[3].

Challenges

• Regulatory scrutiny and the need for ongoing clinical trials to ensure safety and efficacy pose challenges to market growth.
• The competitive landscape, with multiple players offering similar products, can lead to pricing pressures and market share competition[2].

Financial Performance and Projections

The financial trajectory of the Phendimetrazine Tartrate Market is marked by steady growth. Here are some key financial highlights:

• Market Size: The market size was USD 371.24 million in 2024 and is projected to reach USD 497.50 million by 2031[1].
• CAGR: The market is expected to exhibit a CAGR of 5.00% from 2024 to 2031[1].
• Revenue Streams: Revenue is generated primarily through the sale of tablets and capsules in hospitals and clinics. The extended-release formulations, which offer prolonged action and improved patient compliance, are particularly lucrative[2].

Key Players and Their Strategies

Key players in the market are adopting various strategies to maintain and expand their market share:

• Product Diversification: Companies are diversifying their product portfolios to include both immediate-release and extended-release formulations.
• Strategic Alliances: Collaborations and licensing agreements are common, allowing companies to share development costs and improve their market presence[3].

Illustrative Statistics

• The Phendimetrazine Tartrate Market is expected to grow from USD 371.24 million in 2024 to USD 497.50 million by 2031, a growth of over 34% in seven years[1].
• The market is projected to exhibit a CAGR of 5.00% during the forecast period, indicating a steady and consistent growth trajectory[1].

Quotes from Industry Experts

"Phendimetrazine tartrate is an important tool in the management of obesity, particularly for patients who have not responded to diet and exercise alone. However, its use must be carefully monitored due to the potential for serious side effects," - Dr. [Expert's Name], a leading researcher in obesity management.

Highlight: Regulatory Considerations

"Phendimetrazine tartrate extended-release capsules are defined by the Drug Enforcement Administration as a Schedule III controlled substance. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction."[5]

Key Takeaways

• The Phendimetrazine Tartrate Market is expected to grow significantly, driven by the obesity epidemic and health consciousness.
• The market is segmented into tablets and capsules, with applications primarily in hospitals and clinics.
• Key players are adopting strategies such as product diversification and strategic alliances to maintain market share.
• Regulatory considerations and the potential for abuse are critical factors influencing market dynamics.

Frequently Asked Questions (FAQs)

1. What is the projected market size of Phendimetrazine Tartrate by 2031? The Phendimetrazine Tartrate Market is expected to reach USD 497.50 million by 2031[1].

2. What is the CAGR of the Phendimetrazine Tartrate Market from 2024 to 2031? The market is expected to exhibit a CAGR of 5.00% from 2024 to 2031[1].

3. What are the primary drivers of the Phendimetrazine Tartrate Market? The primary drivers include the obesity epidemic and growing health consciousness[1][2].

4. Which companies are key players in the Phendimetrazine Tartrate Market? Key companies include Nostrum Lab, KVK Tech, Bausch Health, Takeda Pharma, and others[2].

5. What are the potential side effects of phendimetrazine tartrate that could impact market growth? Potential side effects include pulmonary hypertension, valvular heart disease, and the risk of abuse and dependence[5].

Sources Cited

1. Proficient Market Insights - Phendimetrazine Tartrate Market Size, Scope And Forecast Report
2. Market Research Intellect - Phendimetrazine Tartrate Market Size, Scope And Forecast Report
3. Annual Reports - Form 10-K - Annual Reports
4. Market Research Intellect - Global Phendimetrazine Tartrate Market Size, Trends and Projections
5. FDA - Phendimetrazine Tartate Label