DICLOFENAC POTASSIUM - Generic Drug Details

What are the generic sources for diclofenac potassium and what is the scope of patent protection?

Diclofenac potassium is the generic ingredient in four branded drugs marketed by Aurobindo Pharma Ltd, Bionpharma, Onesource Specialty, Asio Holdings, Alkem Labs Ltd, Annora Pharma, Ph Health, Taro, Torrent, Umedica, Amici Pharma, Novartis, Chartwell Rx, Novast Labs, Rk Pharma, Rubicon Research, Senores Pharms, Sun Pharm Industries, Teva, and Watson Labs Teva, and is included in twenty-two NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diclofenac potassium has thirty-four patent family members in twenty-three countries.

There are eleven drug master file entries for diclofenac potassium. Forty-seven suppliers are listed for this compound.

Summary for DICLOFENAC POTASSIUM

International Patents:	34
US Patents:	10
Tradenames:	4
Applicants:	20
NDAs:	22
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	40
Patent Applications:	7,587
Drug Prices:	Drug price trends for DICLOFENAC POTASSIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DICLOFENAC POTASSIUM
What excipients (inactive ingredients) are in DICLOFENAC POTASSIUM?	DICLOFENAC POTASSIUM excipients list
DailyMed Link:	DICLOFENAC POTASSIUM at DailyMed

See drug prices for DICLOFENAC POTASSIUM

Recent Clinical Trials for DICLOFENAC POTASSIUM

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

Sponsor	Phase
The Affiliated Hospital of Putian University	NA
Cairo University	NA
Egyptian Russian University	NA

See all DICLOFENAC POTASSIUM clinical trials

Pharmacology for DICLOFENAC POTASSIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for DICLOFENAC POTASSIUM

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

M01AB	Acetic acid derivatives and related substances
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for DICLOFENAC POTASSIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZIPSOR	Capsules	diclofenac potassium	25 mg	022202	1	2012-11-14
CAMBIA	Oral Solution (Sachet)	diclofenac potassium	50 mg	022165	1	2011-01-24

US Patents and Regulatory Information for DICLOFENAC POTASSIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Asio Holdings	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	AB	RX	Yes	Yes	9,561,200
Rk Pharma	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075463-001	Jul 26, 1999	AB	RX	No	No
Watson Labs Teva	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075152-001	Nov 27, 1998		DISCN	No	No
Amici Pharma	CATAFLAM	diclofenac potassium	TABLET;ORAL	076561-002	Jul 21, 2021	AB	RX	No	No

Expired US Patents for DICLOFENAC POTASSIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Asio Holdings	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	6,287,594
Asio Holdings	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	6,974,595
Asio Holdings	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	7,482,377
Asio Holdings	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202-001	Jun 16, 2009	6,365,180

International Patents for DICLOFENAC POTASSIUM

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006133954
China	101272768	Diclofenac formulations and methods of use
Hong Kong	1213814	雙氯芬酸製劑和使用方法 (DICLOFENAC FORMULATIONS AND METHODS OF USE)
Poland	1890680

Market Dynamics and Financial Trajectory for Diclofenac Potassium

Last updated: March 5, 2026

What Are the Current Market Conditions for Diclofenac Potassium?

Diclofenac potassium is a non-steroidal anti-inflammatory drug (NSAID) used primarily for acute pain management, including post-operative and musculoskeletal pain. Its global market reflects the demand for effective analgesics with a rapid onset of action. The drug's market is influenced by regulatory approvals, patent status, generic competition, and regional prescribing patterns.

• The global NSAID market was valued at approximately USD 11.8 billion in 2021[1].
• Diclofenac products, including potassium salts, account for roughly 40% of NSAID sales worldwide[2].
• The drug is marketed under multiple brand names, such as Voltaren Rapid (Novartis), with generic versions available across many regions.

What Are the Market Drivers for Diclofenac Potassium?

Several factors bolster the market presence of diclofenac potassium:

1. High Demand for Pain Management: The prevalence of acute pain conditions and post-operative analgesia sustains demand.
2. Rapid Absorption Profile: The potassium salt form facilitates faster onset compared to diclofenac sodium, appealing for acute pain relief.
3. Established Safety Profile: Decades of use with well-understood adverse events support continued prescribing.
4. Cost-Effectiveness: Generic formulations provide affordable options, increasing accessibility.

How Does Regulatory Environment Impact the Market?

Regulatory decisions significantly influence the market trajectory:

• Regulatory agencies such as the FDA and EMA have approved diclofenac potassium for short-term pain management, but concerns about cardiovascular risks have led to restrictions[3].
• Some countries have imposed restrictions or lowered dosage limits after safety reviews.
• Recent bans or warnings, for instance in the UK, limit over-the-counter availability, pushing sales toward prescription channels.

What Are the Patent and Competitive Dynamics?

Patent expiry for many branded diclofenac potassium formulations occurred around 2015-2018, leading to increased generic competition. This affects revenue streams:

Year	Patent Expiry	Major Generic Launch
2015	US, EU	Multiple generics introduced in US, EU
2018	Japan	Generics expand in Asian markets

Generic versions typically sell at 30-50% of branded prices[4], pressuring profit margins but increasing market penetration.

How Is the Market Evolving Regionally?

• North America: High prescription rates, but growth slowed due to safety concerns and regulatory restrictions.
• Europe: Mature market with extensive generic competition and safety warnings.
• Asia-Pacific: Growing demand due to increasing healthcare access, though regulatory environments vary.
• Latin America and Africa: Emerging markets with expanding access, but limited by affordability and supply chain issues.

What Financial Trends Are Emerging?

Key financial metrics include:

• Revenue decline for branded formulations post-patent expiry, with a compound annual decline rate (CADR) of around 4-6% in mature markets[5].
• Gross margins for generic producers are tight, often around 20-30%.
• R&D investments are focused on safer formulations and fixed-dose combinations to offset declining sales of traditional diclofenac potassium.

What Are Future Market Forecasts?

Projections suggest the global NSAID market will grow at a CAGR of approximately 3% through 2027, driven by rising pain-related conditions and expanding populations aged over 60[6]. Diclofenac potassium's share is expected to decline gradually as newer analgesics with better safety profiles enter the market. However, regional differences persist:

• Recovery in emerging markets due to increased healthcare spending.
• Continued restrictions and safety concerns in developed countries.

Key Takeaways

• Diclofenac potassium market sustains despite safety concerns and patent expirations.
• Generic competition significantly reduces revenue for branded products.
• Regional regulatory changes influence off-label and OTC sales.
• Market growth is moderate, with a shift toward safer or alternative analgesic options.

FAQs

1. What are the primary safety concerns associated with diclofenac potassium?
Cardiovascular risks, gastrointestinal bleeding, and renal impairment are primary concerns, leading to regulatory restrictions in some regions[3].

2. How does patent expiration affect diclofenac potassium revenues?
It enables generic competition, lowers prices, and reduces profitability for branded formulations.

3. Are there alternative drugs with better safety profiles?
Yes, newer NSAIDs and non-NSAID analgesics are considered safer but may have different efficacy profiles.

4. What regions exhibit the highest growth potential for diclofenac potassium?
Emerging markets in Asia-Pacific, Latin America, and Africa show growth due to increasing healthcare access and pain prevalence.

5. Is diclofenac potassium available OTC globally?
No, availability varies; some countries restrict OTC sales due to safety concerns and recommend prescription-only access.

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References

[1] Grand View Research. (2022). NSAID market size, share & trends analysis. https://www.grandviewresearch.com/industry-analysis/non-steroidal-anti-inflammatory-drugs-market

[2] IQVIA. (2021). Global NSAID sales report.

[3] U.S. Food and Drug Administration. (2020). Safety communications on NSAIDs and cardiovascular risk.

[4] Pharma Intelligence. (2019). Impact of patent expiry on NSAID markets.

[5] EvaluatePharma. (2022). Revenue trends for NSAID drugs.

[6] Statista. (2022). Projection of global NSAID market growth.