DICLOFENAC - Generic Drug Details

What are the generic sources for diclofenac and what is the scope of freedom to operate?

Diclofenac is the generic ingredient in sixteen branded drugs marketed by Zyla, Ibsa, Ibsa Inst Bio, Aurobindo Pharma Ltd, Bionpharma, Strides Pharma, Assertio, Alkem Labs Ltd, Annora Pharma, Endo Operations, Taro, Amici Pharma, Novartis, Chartwell Rx, Novast Labs, Rk Pharma, Rubicon, Senores Pharms, Sun Pharm Industries, Teva, Umedica, Watson Labs Teva, Actavis Mid Atlantic, Alembic, Amneal, Amneal Pharms, Aurolife Pharma Llc, Cipla, Encube, Glenmark Pharms Ltd, Hikma, Padagis Israel, Perrigo Pharma Intl, Fougera Pharms, Haleon Us Holdings, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Sandoz, Sciegen Pharms Inc, Javelin Pharms Inc, Apotex, Epic Pharma Llc, Lupin Ltd, Lupin Pharms, Novel Labs Inc, Pai Holdings Pharm, Twi Pharms, Watson Labs Inc, Zydus Lifesciences, Horizon, Nuvo Pharms Inc, Actavis Elizabeth, Aurobindo Pharma Usa, Carlsbad, Micro Labs, Pliva, Roxane, Teva Pharms, Unique, Dexcel Ltd, Riconpharma Llc, Vpna, Pfizer, Actavis Labs Fl Inc, Exela Holdings, Yung Shin Pharm, and Zydus Pharms, and is included in ninety-five NDAs. There are thirty-nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are forty-seven drug master file entries for diclofenac. There are four tentative approvals for this compound.

Summary for DICLOFENAC

International Patents:	44
US Patents:	39
Tradenames:	16
Applicants:	69
NDAs:	95
Drug Master File Entries:	47
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	429
Patent Applications:	7,122
Drug Prices:	Drug price trends for DICLOFENAC
Drug Sales Revenues:	Drug sales revenues for DICLOFENAC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DICLOFENAC
What excipients (inactive ingredients) are in DICLOFENAC?	DICLOFENAC excipients list
DailyMed Link:	DICLOFENAC at DailyMed

See drug prices for DICLOFENAC

See drug sales revenues for DICLOFENAC

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DICLOFENAC

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DICLOFENAC

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

Sponsor	Phase
assertio Therapeutics, Inc	Phase 1/Phase 2
University of Texas Southwestern Medical Center	Phase 1/Phase 2
Washington State University	Early Phase 1

See all DICLOFENAC clinical trials

Generic filers with tentative approvals for DICLOFENAC

Applicant	Application No.	Strength	Dosage Form
		1.5% W/W	SOLUTION;TOPICAL
		2%	SOLUTION;TOPICAL
		35MG	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for DICLOFENAC

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DICLOFENAC

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZORVOLEX	Capsules	diclofenac	18 mg and 35 mg	204592	1	2014-06-06

US Patents and Regulatory Information for DICLOFENAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	DICLOFENAC SODIUM	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	074376-002	Sep 28, 1995		DISCN	No	No
Ibsa	FLECTOR	diclofenac epolamine	SYSTEM;TOPICAL	021234-001	Jan 31, 2007		RX	Yes	Yes
Teva Pharms	DICLOFENAC SODIUM	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	074459-001	Jun 25, 1997		DISCN	No	No
Zydus Lifesciences	DICLOFENAC SODIUM	diclofenac sodium	SOLUTION;TOPICAL	206411-001	Apr 17, 2018	AT	RX	No	No
Sciegen Pharms Inc	DICLOFENAC SODIUM	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	077845-001	Apr 17, 2008		DISCN	No	No
Altaire Pharms Inc	DICLOFENAC SODIUM	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	203383-001	Nov 16, 2015	AT	RX	No	No
Unique	DICLOFENAC SODIUM	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	077863-003	Jun 8, 2007	AB	RX	No	Yes

International Patents for DICLOFENAC

Country	Patent Number	Title	Estimated Expiration
Colombia	6470810	UNA FORMULACIÓN NOVEDOSA DE DICLOFENACO
China	106727477	双氯芬酸的新剂型 (A new formation of diclofenac)
Australia	2014208310	A Novel Formulation of Diclofenac
European Patent Office	3290030	FORMULATION DE DICLOFÉNAC (DICLOFENAC FORMULATION)
China	106727424	双氯芬酸的新剂型 (A novel formulation of diclofenac)
New Zealand	620887	A novel formulation of diclofenac
Japan	2012524723

DICLOFENAC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diclofenac

Introduction

Diclofenac, a widely used non-steroidal anti-inflammatory drug (NSAID), is poised for significant growth in the global pharmaceutical market. This article delves into the market dynamics, financial projections, and key factors influencing the diclofenac market.

Market Size and Growth Projections

The global diclofenac market is expected to experience substantial growth over the next decade. As of 2023, the market was valued at approximately USD 4.2 billion and is projected to reach USD 6.4 billion by 2033, growing at a compound annual growth rate (CAGR) of 4.3% from 2024 to 2033[1].

Another projection suggests that the diclofenac market could reach USD 9.07 billion by 2031, with a CAGR of 4.9% from 2024 to 2031[4]. These varying estimates highlight the robust growth potential of the diclofenac market.

Key Drivers of Market Growth

Several factors are driving the growth of the diclofenac market:

Increasing Incidence of Chronic Pain and Arthritis

The rising prevalence of chronic pain and arthritis, particularly among the aging population, is a significant driver. As the global population ages, the demand for effective pain management treatments like diclofenac is increasing[1][4].

Improvements in Drug Formulations and Delivery Technologies

Advancements in drug formulations and delivery methods, such as gels, patches, and oral solutions, have enhanced the therapeutic efficacy and patient compliance of diclofenac. These innovations are crucial in minimizing side effects and improving patient outcomes[1][4].

Growing Healthcare Needs

The increasing healthcare costs and the need for efficient pain management treatments are also driving the market. Diclofenac's versatility in treating various conditions, including osteoarthritis, rheumatoid arthritis, migraines, and postoperative pain, further supports its demand[4].

Regional Market Dynamics

The Asia Pacific region dominates the diclofenac market, holding a 35.5% share valued at USD 1.5 billion as of 2023. This region's large population and increasing healthcare needs contribute significantly to the market's growth[1].

Market Segmentation

The diclofenac market is segmented based on several criteria:

By Type

Tablets lead the diclofenac types with a 55.5% market share. Other forms, such as gels and patches, also contribute to the market but to a lesser extent[1].

By Disease Indication

Osteoarthritis indications account for 37.5% of diclofenac usage, followed by other chronic inflammatory disorders[1].

By Administration Route

Oral administration is the preferred route for 37% of diclofenac users, highlighting the convenience and efficacy of this method[1].

By Distribution Channel

Retail pharmacies dominate the distribution channels with a 68.4% market share, indicating the widespread availability of diclofenac through traditional retail outlets[1].

Challenges and Restraints

Despite the growth potential, the diclofenac market faces several challenges:

Potential Side Effects

Diclofenac is associated with potential side effects such as cardiovascular and gastrointestinal issues. These side effects could restrain market growth if not adequately addressed through innovative formulations and delivery methods[1].

Innovations and Developments

Recent developments aimed at minimizing side effects and improving safety profiles are crucial for the market's continued growth. For instance:

Enhanced Formulations

New formulations and delivery technologies are being developed to reduce the risk of side effects while maintaining or improving the therapeutic efficacy of diclofenac[1][4].

Regulatory Approvals

Positive regulatory approvals for drugs containing diclofenac and significant investments in research and development (R&D) are expected to maintain market momentum in the upcoming years[4].

Financial Trajectory

The financial trajectory of the diclofenac market is promising, with several key indicators:

Revenue Growth

The market is expected to grow from USD 4.2 billion in 2023 to USD 6.4 billion by 2033, or alternatively to USD 9.07 billion by 2031, depending on the projection[1][4].

CAGR

The CAGR for the diclofenac market is estimated to be around 4.3% to 4.9% over the forecast period, indicating steady and significant growth[1][4].

Regional Contributions

The Asia Pacific region's substantial contribution to the market, along with other regions, will continue to drive the financial growth of the diclofenac market[1].

Key Players and Market Competition

The diclofenac market is competitive, with several key players involved in the development, manufacturing, and distribution of the drug. Companies like Depomed, which acquired CAMBIA (diclofenac potassium for oral solution), are making strategic moves to strengthen their market positions[5].

Conclusion

The diclofenac market is poised for significant growth driven by increasing demand for pain management treatments, advancements in drug formulations, and the growing healthcare needs of an aging population. Despite challenges related to side effects, innovations and positive regulatory approvals are expected to support the market's expansion.

Key Takeaways

• Market Growth: The global diclofenac market is projected to grow from USD 4.2 billion in 2023 to USD 6.4 billion by 2033, or USD 9.07 billion by 2031.
• CAGR: The market is expected to grow at a CAGR of 4.3% to 4.9% over the forecast period.
• Regional Dominance: The Asia Pacific region dominates the market with a 35.5% share.
• Market Segmentation: Tablets lead the market share by type, while osteoarthritis indications account for the largest share by disease indication.
• Distribution Channels: Retail pharmacies dominate the distribution channels.

FAQs

Q: What is the projected market size of the global diclofenac market by 2033? A: The global diclofenac market is projected to reach approximately USD 6.4 billion by 2033[1].

Q: What is the primary driver of the diclofenac market growth? A: The primary driver is the increasing incidence of chronic pain and arthritis, particularly among the aging population[1][4].

Q: Which region dominates the diclofenac market? A: The Asia Pacific region dominates the diclofenac market with a 35.5% share[1].

Q: What are the common side effects associated with diclofenac? A: Diclofenac is associated with potential side effects such as cardiovascular and gastrointestinal issues[1].

Q: How is the market segmented in terms of administration route? A: Oral administration is the preferred route for 37% of diclofenac users[1].

Sources

1. Market.us News: Diclofenac Market Growth Accelerates Amid Increased Demand.
2. Market Research Intellect: Diclofenac Diethylamine Market Size, Scope And Forecast Report.
3. DrugPatentWatch: DICLOFENAC SODIUM - Generic Drug Details.
4. Market Research Intellect: Diclofenac Market Size, Trends and Projections.
5. FirstWord Pharma: Depomed Acquires CAMBIA (Diclofenac Potassium for Oral Solution).