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, Pharmaco, Ani Pharms, Dava Pharms Inc, Ivax Sub Teva Pharms, Strides Pharma Intl, 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. Five 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:	5
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	177
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
Watson Labs	FENOPROFEN CALCIUM	fenoprofen calcium	CAPSULE;ORAL	072293-001	Aug 17, 1988		DISCN	No	No
Warner Chilcott	FENOPROFEN CALCIUM	fenoprofen calcium	CAPSULE;ORAL	072946-001	Apr 30, 1991		DISCN	No	No
Dista	NALFON	fenoprofen calcium	TABLET;ORAL	017710-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Rising	FENOPROFEN CALCIUM	fenoprofen calcium	TABLET;ORAL	072396-001	Oct 17, 1988		DISCN	No	No
Par Pharm	FENOPROFEN CALCIUM	fenoprofen calcium	CAPSULE;ORAL	072437-001	Aug 22, 1988		DISCN	No	No
Usl Pharma	FENOPROFEN CALCIUM	fenoprofen calcium	TABLET;ORAL	072362-001	Aug 17, 1988		DISCN	No	No

Expired US Patents for FENOPROFEN CALCIUM

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

Market Dynamics and Financial Trajectory for Fenoprofen Calcium

Last updated: February 19, 2026

What is the current market position of Fenoprofen Calcium?

Fenoprofen calcium is a nonsteroidal anti-inflammatory drug (NSAID) primarily used for managing pain, inflammation, and arthritis symptoms. It is marketed under brand names such as Nalfon in the United States. Its market presence is limited compared to large NSAID classes like ibuprofen and naproxen.

The drug holds a niche position due to its specific approval profile, regional marketing, and competition. It was approved in 1980 by the U.S. Food and Drug Administration (FDA) but has seen a decline in usage, attributed to safety concerns over NSAID-related gastrointestinal and cardiovascular risks.

How does the regulatory landscape influence Fenoprofen Calcium's market dynamics?

Fenoprofen calcium's approval restrictions, safety warnings, and the availability of alternative NSAIDs have shaped its market trajectory. The FDA classifies Fenoprofen as a risk for gastrointestinal bleeding and cardiovascular events, leading to diminished prescription volume. This impacts potential revenue and adoption.

International regulations vary; for instance, in the European Union, Fenoprofen's market has been largely phased out due to safety concerns. Some Asian markets still permit its sale in specific indications, but overall, regulatory restrictions impede widespread adoption.

What are the key drivers and barriers affecting its financial outlook?

Drivers:

• Niche indications: Some patients with NSAID allergies or intolerance may still use Fenoprofen.
• Established safety profile: Long-term market presence provides a degree of clinical familiarity.

Barriers:

• Safety profile concerns: Risk of gastrointestinal and cardiovascular adverse events deters widespread use.
• Availability of superior alternatives: Drugs like ibuprofen, naproxen, and celecoxib offer better safety and efficacy.
• Limited approval extensions: No significant regulatory updates expanding its indications or formulations.

What does the sales and revenue landscape look like?

Fenoprofen calcium's global sales are minor relative to the NSAID class, with estimated annual revenues below $10 million. US prescription volume has declined steadily since the early 2000s, from several hundred thousand prescriptions per year to fewer than 50,000 in recent reports.

In European markets, sales are negligible or absent due to regulatory withdrawal. In Asian markets, sales are sporadic and primarily generics, with limited data on revenue contributions.

How might market trends evolve over the next five years?

Market decline is expected to continue due to safety concerns and competitive pressure from novel agents. However, niche uses may sustain low-level demand. Potential growth hinges on reformulations or new indications, but these are not currently underway.

Drug patent status is unremarkable; Fenoprofen calcium's original patent has expired, and generics dominate supply, suppressing prices and margins.

What are the financial implications for pharmaceutical companies?

The declining sales trajectory indicates minimal investment interest and negligible revenue contribution. Companies may choose to phase out manufacturing unless new indications or formulations emerge. Investment in clinical development for Fenoprofen calcium appears unlikely given the safety profile and market competition.

Summary of market and financial data

Aspect	Details
Approved Year	1980 (FDA, US)
Market Status (US)	Declining, limited prescriptions (<50,000/year)
Estimated Annual Revenue	<$10 million globally
Patent Status	Expired; generics dominate
Regulatory Restrictions	Yes (Gastrointestinal, cardiovascular risks)
Competitive Alternatives	Ibuprofen, naproxen, celecoxib, other NSAIDs

Key Takeaways

• Fenoprofen calcium has a niche but declining presence due to safety concerns.
• Its sales are suppressed by competition and regulation, with global revenues below $10 million annually.
• Future growth prospects are limited unless new indications or formulations are developed.
• Market exit is likely unless significant reformulation or safety improvements occur.
• Investment in Fenoprofen calcium faces low returns given current market dynamics.

FAQs

Q1: Could Fenoprofen calcium re-enter the market with better safety profiles?
A1: Unlikely without significant reformulation or safety improvements, as existing safety concerns outweigh potential benefits.

Q2: Are there any ongoing clinical trials for Fenoprofen calcium?
A2: No publicly reported advanced clinical trials aim to extend indications or improve safety.

Q3: What regions still see prescription usage of Fenoprofen calcium?
A3: Limited, mainly in select Asian markets with less regulatory restriction.

Q4: How does Fenoprofen calcium compare to other NSAIDs financially?
A4: It generates substantially less revenue—less than $10 million annually—compared to high-revenue NSAIDs like ibuprofen, which exceeds $1 billion annually globally.

Q5: Is there potential for generic manufacturers to dominate Fenoprofen calcium sales?
A5: Yes; patent expiration has led to generic proliferation, keeping prices low and limiting margins.

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References

[1] U.S. Food and Drug Administration (1980). Fenoprofen calcium approval documents.
[2] IQVIA (2022). Global NSAID market report.
[3] European Medicines Agency (2021). NSAID safety assessments.
[4] ClinicalTrials.gov. Fenoprofen calcium studies.