FENOPROFEN CALCIUM - Generic Drug Details

What are the generic drug sources for fenoprofen calcium and what is the scope of patent protection?

Fenoprofen calcium is the generic ingredient in two branded drugs marketed by Am Therap, Halsey, Misemer, Par Pharm, Quantum Pharmics, Rising, Warner Chilcott, Watson Labs, Key Therap, Ani Pharms, Dava Pharms Inc, Ivax Sub Teva Pharms, Strides Pharma, Sun Pharm Industries, Usl Pharma, Watson Labs Teva, and Dista, and is included in thirty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for fenoprofen calcium. Eight suppliers are listed for this compound.

Summary for FENOPROFEN CALCIUM

US Patents:	0
Tradenames:	2
Applicants:	17
NDAs:	34
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	211
Clinical Trials:	1
Patent Applications:	1,283
What excipients (inactive ingredients) are in FENOPROFEN CALCIUM?	FENOPROFEN CALCIUM excipients list
DailyMed Link:	FENOPROFEN CALCIUM at DailyMed

Recent Clinical Trials for FENOPROFEN CALCIUM

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 FENOPROFEN CALCIUM clinical trials

Pharmacology for FENOPROFEN CALCIUM

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for FENOPROFEN CALCIUM

Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for FENOPROFEN CALCIUM

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

US Patents and Regulatory Information for FENOPROFEN CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	FENOPROFEN CALCIUM	fenoprofen calcium	CAPSULE;ORAL	214475-003	Jul 26, 2024		RX	No	No
Rising	FENOPROFEN CALCIUM	fenoprofen calcium	CAPSULE;ORAL	072395-001	Oct 17, 1988		DISCN	No	No
Halsey	FENOPROFEN CALCIUM	fenoprofen calcium	CAPSULE;ORAL	072356-001	Aug 17, 1988		DISCN	No	No
Watson Labs	FENOPROFEN CALCIUM	fenoprofen calcium	CAPSULE;ORAL	072293-001	Aug 17, 1988		DISCN	No	No
Rising	FENOPROFEN CALCIUM	fenoprofen calcium	CAPSULE;ORAL	214475-002	Jul 26, 2024		RX	No	No
Am Therap	FENOPROFEN CALCIUM	fenoprofen calcium	TABLET;ORAL	072309-001	Aug 17, 1988		DISCN	No	No
Warner Chilcott	FENOPROFEN CALCIUM	fenoprofen calcium	CAPSULE;ORAL	072472-001	Apr 30, 1991		DISCN	No	No

Expired US Patents for FENOPROFEN CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Key Therap	NALFON	fenoprofen calcium	CAPSULE;ORAL	017604-003	Approved Prior to Jan 1, 1982
Dista	NALFON	fenoprofen calcium	TABLET;ORAL	017710-001	Approved Prior to Jan 1, 1982
Key Therap	NALFON	fenoprofen calcium	CAPSULE;ORAL	017604-002	Approved Prior to Jan 1, 1982

FENOPROFEN CALCIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Fenoprofen Calcium

Introduction

Fenoprofen calcium, a nonsteroidal anti-inflammatory drug (NSAID), has been a significant player in the pharmaceutical market, particularly in the treatment of mild to moderate pain and symptoms of arthritis. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global fenoprofen calcium market has experienced substantial growth in recent years. Projections indicate that this trend is likely to continue from 2023 to 2031, driven by increasing demand for effective pain management and anti-inflammatory treatments[1][4].

Market Drivers

Several factors are driving the growth of the fenoprofen calcium market:

• Increasing Prevalence of Arthritis: The rising incidence of osteoarthritis and rheumatoid arthritis globally is a major driver, as fenoprofen calcium is commonly prescribed to alleviate symptoms associated with these conditions[5].
• Aging Population: The aging population is more prone to chronic pain and arthritis, leading to higher demand for NSAIDs like fenoprofen calcium.
• Generic Market Expansion: The approval of generic versions of fenoprofen calcium, such as the one by Rising Pharma Holdings, Inc., has expanded market access and affordability, contributing to market growth[2].

Competitive Landscape

The fenoprofen calcium market is characterized by a mix of branded and generic products. Key players include:

• Branded Products: Nalfon, the original brand name for fenoprofen calcium, remains a significant player in the market.
• Generic Products: The approval of generic fenoprofen calcium capsules by companies like Rising Pharma Holdings, Inc., has introduced competition and reduced prices, making the drug more accessible to a wider audience[2].

Regulatory Environment

Regulatory approvals and designations play a crucial role in shaping the market dynamics:

• FDA Approvals: The FDA's approval of generic fenoprofen calcium capsules, such as the one by Rising Pharma Holdings, Inc., with a Competitive Generic Therapy (CGT) designation, provides 180 days of exclusivity. This exclusivity period can significantly impact market share and revenue for the first approved applicant[2].
• Postmarketing Requirements: Companies must adhere to strict postmarketing reporting requirements, including notifications of any changes in marketing status or adverse effects, to ensure continued approval and market presence[2].

Financial Trajectory

The financial performance of fenoprofen calcium is influenced by several factors:

• Revenue Growth: The market is expected to see sustained revenue growth due to increasing demand and the expansion of generic products. The global fenoprofen calcium market size is projected to increase significantly over the next few years[1][4].
• Cost and Pricing: The introduction of generic versions has led to a reduction in prices, making the drug more affordable and increasing its market penetration. However, this also means that profit margins for manufacturers may be affected[2].
• Research and Development: Continuous research into new formulations and delivery systems, such as the use of polymers to enhance the physicochemical properties and biological performance of fenoprofen calcium, can lead to new revenue streams and improved market positioning[3].

Market Challenges

Despite the growth, the fenoprofen calcium market faces several challenges:

• Side Effects and Safety Concerns: NSAIDs, including fenoprofen calcium, are associated with potential side effects such as gastrointestinal bleeding, heart attacks, and strokes. These safety concerns can impact market growth and require careful risk management strategies[5].
• Competition from Other NSAIDs: The NSAID market is highly competitive, with other drugs like ibuprofen and naproxen competing for market share. Differentiating fenoprofen calcium through its efficacy and safety profile is crucial[5].

Market Opportunities

There are several opportunities for growth and expansion:

• Emerging Markets: Expanding into emerging markets where access to pain management and anti-inflammatory drugs is limited can provide significant growth opportunities.
• New Formulations: Developing new formulations, such as sustained-release formulations, can enhance patient compliance and therapeutic efficacy, potentially increasing market share[3].

Key Takeaways

• The global fenoprofen calcium market is expected to grow significantly due to increasing demand for pain management and anti-inflammatory treatments.
• Generic versions and regulatory approvals are key drivers of market expansion.
• The financial trajectory is influenced by revenue growth, cost and pricing dynamics, and ongoing research and development.
• Despite challenges, opportunities exist in emerging markets and new formulations.

FAQs

What is fenoprofen calcium used for?

Fenoprofen calcium is used to treat mild to moderate pain and symptoms of arthritis, including osteoarthritis and rheumatoid arthritis[5].

What are the common side effects of fenoprofen calcium?

Common side effects include acid or sour stomach, belching, constipation, headache, heartburn, and sleepiness. Serious side effects can include gastrointestinal bleeding, heart attacks, and strokes[5].

What is the typical dosage of fenoprofen calcium?

For mild to moderate pain, the typical dosage is 200 mg every 4 to 6 hours. For rheumatoid arthritis and osteoarthritis, the dosage can range from 400 to 600 mg three or four times a day[5].

Is fenoprofen calcium available in generic form?

Yes, fenoprofen calcium is available in generic form, with companies like Rising Pharma Holdings, Inc., receiving FDA approval for their generic versions[2].

What are the regulatory requirements for fenoprofen calcium?

Manufacturers must comply with FDA regulations, including postmarketing reporting requirements and notifications of any changes in marketing status or adverse effects[2].

Sources

1. Market Research Intellect: Global Fenoprofen Calcium Market Size, Scope And Forecast Report.
2. FDA: Fenoprofen Calcium Capsules - accessdata.fda.gov.
3. MDPI: Effect of Polymers on the Physicochemical Properties and Biological Performance of Fenoprofen Calcium Dihydrate-Triacetyl-β-Cyclodextrin Complex.
4. Market Research Guru: Global Fenoprofen Calcium Market - Industry Reports.
5. Mayo Clinic: Fenoprofen (oral route) - Mayo Clinic.