CATAFLAM Drug Patent Profile

Which patents cover Cataflam, and what generic alternatives are available?

Cataflam is a drug marketed by Amici Pharma and Novartis and is included in two NDAs.

The generic ingredient in CATAFLAM is diclofenac potassium. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cataflam

A generic version of CATAFLAM was approved as diclofenac potassium by TEVA on August 6^th, 1998.

Summary for CATAFLAM

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	17
Patent Applications:	5,256
DailyMed Link:	CATAFLAM at DailyMed

Recent Clinical Trials for CATAFLAM

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

Sponsor	Phase
Cairo University	PHASE3
Ain Shams University	PHASE4
Cairo University	Phase 4

See all CATAFLAM clinical trials

Pharmacology for CATAFLAM

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

US Patents and Regulatory Information for CATAFLAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amici Pharma	CATAFLAM	diclofenac potassium	TABLET;ORAL	076561-002	Jul 21, 2021	AB	RX	No	No
Novartis	CATAFLAM	diclofenac potassium	TABLET;ORAL	020142-002	Nov 24, 1993		DISCN	Yes	No
Amici Pharma	CATAFLAM	diclofenac potassium	TABLET;ORAL	076561-001	Mar 18, 2004	AB	RX	No	No
Novartis	CATAFLAM	diclofenac potassium	TABLET;ORAL	020142-001	Nov 24, 1993		DISCN	Yes	No

Cataflam Market Dynamics, Patent Position, and Financial Trajectory

Last updated: August 10, 2026

Cataflam is the brand name for diclofenac potassium, an immediate-release nonsteroidal anti-inflammatory drug used for short-term treatment of pain and inflammation. Its commercial trajectory is defined by long-established generic competition, limited brand differentiation, mature regulatory status, and low barriers to substitution. Cataflam is no longer an innovation-driven asset, and its financial value depends primarily on residual brand recognition, supply availability, geographic rights, and channel positioning.

What is Cataflam and how is diclofenac potassium used?

Cataflam contains diclofenac potassium, a nonselective cyclooxygenase inhibitor. The drug is marketed in immediate-release oral tablets and has historically been used for acute pain, dysmenorrhea, dental pain, musculoskeletal conditions, and inflammatory disorders.

Attribute	Cataflam
Active ingredient	Diclofenac potassium
Drug class	NSAID
Common dosage form	Immediate-release film-coated tablet
Historic U.S. strength	50 mg
Original innovator	Novartis
Regulatory pathway	New Drug Application
Primary therapeutic use	Short-term pain and inflammation
Generic status	Mature generic market
Biosimilar relevance	None
Current commercial profile	Legacy branded product competing with generics

Diclofenac potassium differs from diclofenac sodium primarily in salt form, dissolution characteristics, and product formulation. The potassium salt is generally associated with relatively rapid release, while diclofenac sodium is used in multiple oral, topical, ophthalmic, and injectable products.

FDA labeling warns of cardiovascular thrombotic events, gastrointestinal bleeding, ulceration, renal toxicity, hepatotoxicity, hypertension, and serious skin reactions. These class-wide NSAID risks restrict chronic use and affect product positioning against lower-risk or more targeted therapies.[1]

What is the Orange Book status of Cataflam?

Cataflam was listed in the FDA Orange Book under Novartis-related sponsorship for diclofenac potassium tablets. The relevant U.S. product is associated with NDA 019998 in FDA regulatory records. The product’s market position is that of an older prescription drug with no meaningful remaining pioneer exclusivity.

The commercial distinction between “listed,” “marketed,” and “prescription available” matters. A product may remain in FDA records while the branded product is discontinued, commercially unavailable, or supplied only in selected markets. FDA’s discontinued-drug records and current labeling should be used to determine active U.S. distribution at a specific date.[2]

Does Cataflam have active Orange Book patents?

Cataflam’s original composition and product patents expired long ago. No commercially significant patent barrier is generally associated with the basic diclofenac potassium tablet.

IP category	Cataflam position
Original active-ingredient patent	Expired
Basic tablet composition	Expired or commercially irrelevant
Core formulation protection	Expired
Method-of-use patents	No material barrier for ordinary pain indications
Pediatric exclusivity	Not a current commercial barrier
Orphan exclusivity	None
Patent-term extension	Not relevant to current generic access
Biosimilar exclusivity	Not applicable

The absence of a current patent moat allows multiple manufacturers to compete on price, supply reliability, regulatory approvals, and pharmacy access.

When did Cataflam lose exclusivity?

Cataflam lost effective exclusivity after the expiration of the original regulatory and patent protections for diclofenac potassium. Generic diclofenac potassium tablets have been available for many years, making the product a mature multisource medicine rather than a protected brand.

The key commercial event was not a single recent loss-of-exclusivity date. It was the transition from a branded prescription product to a generic market in which manufacturers could compete through abbreviated new drug applications. Once ANDA approvals became available, the original brand faced:

• therapeutic substitution by generic diclofenac products;
• formulary pressure from payers;
• pharmacy substitution;
• lower average selling prices;
• reduced physician dependence on the Cataflam name;
• competition from diclofenac sodium and other NSAIDs.

How many patents cover Cataflam?

No active patent estate appears to provide meaningful protection for the basic Cataflam product in the United States. The relevant intellectual-property landscape is fragmented across legacy diclofenac products, topical delivery systems, combination products, and modified-release formulations.

What formulations are protected around diclofenac?

Although the basic Cataflam tablet is mature, later diclofenac products have used formulation and delivery patents involving:

• topical gels and solutions;
• ophthalmic formulations;
• injectable preparations;
• extended-release tablets;
• liquid-filled capsules;
• solubilized diclofenac formulations;
• diclofenac combined with proton-pump inhibitors;
• diclofenac-misoprostol combinations;
• diclofenac salts other than potassium.

These patents generally protect a specific dosage form, excipient system, release profile, or route of administration. They do not restore exclusivity to standard Cataflam tablets.

Are there manufacturing or IP barriers?

Manufacturing barriers are low for standard diclofenac potassium tablets. The active ingredient is an established small molecule, and the tablet does not require complex biologic production, specialized device engineering, or cold-chain logistics.

Operational barriers can still affect supply:

• API quality and capacity;
• impurity controls;
• nitrosamine or other impurity assessments;
• bioequivalence testing;
• regulatory compliance;
• packaging and serialization requirements;
• local procurement tenders;
• product discontinuations by low-margin manufacturers.

These are execution barriers, not durable exclusivity barriers.

Which companies compete with Cataflam?

Cataflam competes against both generic diclofenac products and alternative NSAIDs. Competition varies by country because brand ownership, pharmacy substitution rules, and reimbursement policies differ.

Competitive segment	Representative products or companies
Generic diclofenac potassium	Teva, Mylan/Viatris, Sandoz, Zydus, Dr. Reddy’s, Apotex and regional manufacturers
Diclofenac sodium	Multiple generic manufacturers
Branded diclofenac	Voltaren, Voltarol and local-market brands
Other oral NSAIDs	Ibuprofen, naproxen, ketoprofen, meloxicam, celecoxib
Combination products	Diclofenac with misoprostol or other co-therapies
Topical alternatives	Diclofenac gel, solution, patch and cream products

The main direct competitors are generic diclofenac potassium tablets. The main therapeutic competitors are ibuprofen and naproxen, which benefit from broad consumer recognition and extensive over-the-counter distribution in many countries.

Cataflam’s strongest residual advantage is brand familiarity in markets where physicians and patients still associate the name with rapid-onset prescription pain relief. That advantage is weak where generic substitution is automatic.

What is the financial trajectory of Cataflam?

Cataflam’s standalone revenue is not publicly reported in Novartis financial statements. The product’s financial trajectory therefore must be assessed through portfolio position, market structure, and generic erosion rather than a disclosed product-level revenue series.

Historical trajectory

Cataflam followed the standard pattern for a mature small-molecule prescription product:

1. initial branded growth following launch;
2. physician adoption for acute pain and inflammatory conditions;
3. loss of exclusivity;
4. rapid price and market-share erosion;
5. migration from branded prescriptions to generic prescriptions;
6. residual brand sales in selected countries and channels;
7. possible discontinuation or license-based commercialization.

This trajectory creates a steep decline in branded revenue after generic entry. Unit demand for diclofenac as a molecule can remain substantial even as Cataflam brand revenue falls.

Current revenue exposure

Cataflam is unlikely to be a material contributor to the consolidated revenue of a large multinational pharmaceutical company. Its financial relevance is more likely to appear in:

• regional branded-generic portfolios;
• licensing or distribution arrangements;
• hospital and tender contracts;
• emerging-market prescription channels;
• over-the-counter or pharmacy-led markets where permitted;
• residual brand sales where generic substitution is incomplete.

Financial driver	Expected effect on Cataflam
Generic entry	Strong negative effect on branded price and share
OTC availability of alternatives	Negative effect on prescription demand
Brand recognition	Supports residual demand
Tender procurement	Negative for price; may support volume
Supply shortages	Can temporarily support substitution or price
Regulatory restrictions on NSAIDs	Negative for chronic-use demand
Topical diclofenac growth	Shifts demand away from oral Cataflam
Emerging-market expansion	May preserve unit volume but at lower prices

Cataflam’s unit sales may remain stable in certain countries while revenue declines because payer and pharmacy discounts reduce net price. In mature markets, the brand’s economic value is generally lower than the value of the broader diclofenac category.

What FDA regulatory issues affect Cataflam?

Cataflam remains subject to the standard NSAID safety framework. FDA labeling includes a boxed warning concerning cardiovascular and gastrointestinal risks. The drug is contraindicated in the setting of perioperative coronary artery bypass graft surgery and carries warnings regarding:

• myocardial infarction and stroke;
• gastrointestinal bleeding and perforation;
• renal injury;
• fluid retention and heart failure;
• hypertension;
• hepatic injury;
• anaphylactoid reactions;
• serious skin reactions;
• fetal toxicity during later pregnancy.

These warnings constrain long-duration treatment and may favor lower-dose, short-course prescribing. They also increase the commercial importance of topical diclofenac, non-NSAID analgesics, and therapies perceived as having more favorable tolerability profiles.[1]

What Paragraph IV challenges and litigation affect Cataflam?

Cataflam is not currently defined by an active Paragraph IV litigation campaign. Its core product is an old small-molecule medicine with generic competition established long ago. Paragraph IV disputes were more relevant during the original generic-entry period, when ANDA applicants could challenge any listed patent protecting the product.

For a mature product such as Cataflam, the key legal risks are more likely to involve:

• manufacturing quality;
• product recalls;
• labeling compliance;
• supply agreements;
• trademark ownership;
• regional distribution rights;
• false advertising;
• product-liability claims;
• patent disputes involving newer diclofenac formulations.

A generic manufacturer seeking approval for standard diclofenac potassium tablets would normally rely on an ANDA demonstrating pharmaceutical equivalence and bioequivalence, subject to the applicable Orange Book certification framework.[2]

Are biosimilars a risk to Cataflam?

No. Cataflam is a chemically synthesized small molecule, not a biologic. Biosimilar competition does not apply. The relevant competitive threat is generic substitution, along with therapeutic competition from other NSAIDs and non-NSAID pain treatments.

This distinction matters commercially. Generic entry is typically faster and less complex than biosimilar development because the regulatory pathway relies on pharmaceutical equivalence and bioequivalence rather than analytical, clinical, and immunogenicity comparability requirements associated with biologics.

How does Cataflam compare with Voltaren and other diclofenac products?

Cataflam and Voltaren share diclofenac as the active pharmaceutical ingredient, but they occupy different product and commercial positions.

Product	Salt or formulation	Route	Commercial position
Cataflam	Diclofenac potassium immediate-release tablet	Oral	Prescription acute-pain brand
Voltaren tablets	Often diclofenac sodium, depending on market	Oral	Prescription or legacy branded product
Voltaren topical gel	Diclofenac sodium topical formulation	Topical	Consumer and prescription product
Generic diclofenac potassium	Diclofenac potassium tablet	Oral	Low-cost multisource product
Generic diclofenac sodium	Diclofenac sodium tablet or other form	Oral/topical	Broad generic competition

Voltaren’s topical franchise has had stronger brand-extension potential because topical delivery responds to concerns about systemic NSAID exposure and is available through consumer-health channels in multiple markets. Cataflam’s oral tablet franchise has fewer avenues for premium pricing.

What generic launch risks exist for Cataflam?

Generic launch risk is already realized for the standard product. Future market disruption would arise from additional suppliers, lower-cost API sources, or formulation alternatives rather than from a first generic launch.

The commercial impact of a new generic entrant would likely include:

• lower wholesale acquisition cost;
• additional pharmacy substitution;
• reduced brand retention;
• tender price compression;
• inventory volatility;
• greater dependence on manufacturing efficiency.

The most significant residual risk to a brand owner is not legal exclusion. It is continued erosion of net price and channel access.

What licensing deals affect Cataflam?

Cataflam has historically been associated with Novartis, but brand ownership and distribution can differ by jurisdiction. Large pharmaceutical companies commonly retain, license, transfer, or discontinue mature products based on portfolio strategy. Product-level licensing economics for Cataflam are not separately disclosed in public corporate reporting.

A local licensee may preserve sales in markets where:

• the Cataflam trademark has high physician recognition;
• generic substitution is incomplete;
• local registration creates a distribution advantage;
• the product is included in institutional tenders;
• the licensee can manufacture or source at low cost.

The economic value of a license is likely to depend more on territory, registration status, manufacturing rights, and minimum purchase commitments than on patent exclusivity.

What is the geographic coverage of Cataflam?

Cataflam has been marketed internationally under the Cataflam name or related diclofenac brands. Regulatory status varies by country, including:

• prescription-only classification;
• pharmacy or nonprescription availability;
• different approved strengths;
• different indications;
• local brand ownership;
• local generic substitution rules;
• distinct marketing authorization holders.

A country-by-country assessment is essential for transaction diligence because a brand may be commercially active in one territory while discontinued in another. Global molecule demand is broader than Cataflam brand demand.

How strong is the Cataflam patent estate?

The patent estate is weak for the original oral tablet and does not support premium valuation based on exclusivity. Cataflam has:

• no meaningful active composition-of-matter protection;
• no relevant biologic exclusivity;
• no durable patent barrier against standard generic tablets;
• limited differentiation from other diclofenac products;
• possible trademark value in selected markets;
• possible regulatory and distribution value independent of patents.

The asset’s defensibility is commercial rather than technological. Brand recognition, supply continuity, local registrations, and physician familiarity may support residual value, but these advantages are vulnerable to generic price competition.

Key Takeaways

• Cataflam is diclofenac potassium, an established oral NSAID with a mature generic market.
• Its original patent and regulatory exclusivity have expired.
• Standard diclofenac potassium tablets face low legal and manufacturing barriers to entry.
• Cataflam’s standalone revenue is not separately disclosed by Novartis or comparable public-company reporting.
• Branded revenue has followed the typical post-exclusivity decline, while broader diclofenac demand remains substantial.
• The principal risks are generic substitution, price compression, product discontinuation, and safety-related prescribing restrictions.
• Biosimilars are irrelevant because diclofenac is a small-molecule drug.
• Topical diclofenac products, including Voltaren-branded products, have stronger brand-extension potential than oral Cataflam.
• Current commercial value is concentrated in residual brand equity, geographic registrations, supply capability, and distribution rights rather than patent protection.

FAQs About Cataflam Market and Exclusivity

Is Cataflam still patented?

The original Cataflam tablet is not protected by a commercially meaningful active patent estate. Generic diclofenac potassium products compete with the branded product.

Is Cataflam the same as diclofenac?

Cataflam is a brand containing diclofenac potassium. Diclofenac sodium and diclofenac potassium are different salt forms of diclofenac and may have different formulations, release properties, and regulatory labels.

Can generic companies launch diclofenac potassium without a license from Cataflam?

Yes. Approved generic manufacturers do not need a Cataflam trademark license to sell their own diclofenac potassium products, provided they satisfy applicable regulatory requirements and avoid infringing any relevant active rights.

Why can Cataflam retain sales after generic entry?

Residual sales can persist because of brand recognition, physician prescribing habits, patient familiarity, market-specific substitution rules, local distribution arrangements, and supply gaps affecting generic competitors.

Does Cataflam have higher commercial value than generic diclofenac?

Usually not on a volume-adjusted basis. The brand may command a higher unit price in selected markets, but generic competition and payer substitution generally reduce the premium and limit long-term revenue growth.

References

1. U.S. Food and Drug Administration. (2015). Cataflam (diclofenac potassium) tablets prescribing information. FDA.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

3. U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs database. FDA.

4. Novartis AG. (2023). Annual report 2023. Novartis.

5. World Health Organization. (2020). WHO guideline for the pharmacological treatment of persisting pain in children with medical illnesses. World Health Organization.