DICLOFENAC SODIUM; MISOPROSTOL - Generic Drug Details

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

Diclofenac sodium; misoprostol is the generic ingredient in two branded drugs marketed by Pfizer, Actavis Labs Fl Inc, Amneal Pharms, Exela Holdings, Micro Labs, Sandoz, Yung Shin Pharm, and Zydus Pharms, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Twelve suppliers are listed for this compound.

Summary for DICLOFENAC SODIUM; MISOPROSTOL

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	12
DailyMed Link:	DICLOFENAC SODIUM; MISOPROSTOL at DailyMed

Pharmacology for DICLOFENAC SODIUM; MISOPROSTOL

Drug Class	Nonsteroidal Anti-inflammatory Drug Prostaglandin E1 Analog
Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

Anatomical Therapeutic Chemical (ATC) Classes for DICLOFENAC SODIUM; MISOPROSTOL

A02BB	Prostaglandins
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

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

G02AD	Prostaglandins
G02A	UTEROTONICS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

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 SODIUM; MISOPROSTOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ARTHROTEC	Delayed-release Tablets	diclofenac sodium; misoprostol	50 mg/0.2 mg	020607	1	2009-06-29
ARTHROTEC	Delayed-release Tablets	diclofenac sodium; misoprostol	75 mg/0.2 mg	020607	1	2008-11-28

US Patents and Regulatory Information for DICLOFENAC SODIUM; MISOPROSTOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	DICLOFENAC SODIUM AND MISOPROSTOL	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	206771-001	Jun 12, 2023		DISCN	No	No
Yung Shin Pharm	DICLOFENAC SODIUM AND MISOPROSTOL	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	205143-002	Feb 19, 2020	AB	RX	No	No
Actavis Labs Fl Inc	DICLOFENAC SODIUM AND MISOPROSTOL	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	201089-002	Jul 9, 2012	AB	RX	No	No
Yung Shin Pharm	DICLOFENAC SODIUM AND MISOPROSTOL	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	205143-001	Feb 19, 2020	AB	RX	No	No
Amneal Pharms	DICLOFENAC SODIUM AND MISOPROSTOL	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	203995-001	Nov 25, 2016	AB	RX	No	No
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-001	Dec 24, 1997	AB	RX	Yes	No
Exela Holdings	DICLOFENAC SODIUM AND MISOPROSTOL	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	200540-001	Mar 14, 2014		DISCN	No	No

Expired US Patents for DICLOFENAC SODIUM; MISOPROSTOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997	5,601,843
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-001	Dec 24, 1997	4,301,146
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997	5,698,225
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997	4,301,146
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-001	Dec 24, 1997	5,698,225
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-001	Dec 24, 1997	5,601,843

DICLOFENAC SODIUM; MISOPROSTOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diclofenac Sodium and Misoprostol

Introduction

Diclofenac sodium and misoprostol, commonly known by the brand name Arthrotec, is a combination drug used to treat various arthritic conditions and prevent gastrointestinal ulcers associated with nonsteroidal anti-inflammatory drug (NSAID) use. Here, we delve into the market dynamics and financial trajectory of this medication.

Market Size and Growth

The global diclofenac market, which includes diclofenac sodium and misoprostol combinations, is projected to experience significant growth. As of 2023, the market was valued at USD 4.2 billion and is expected to reach USD 6.4 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 4.3% during the forecast period from 2024 to 2033[3].

Key Drivers of Market Growth

Rising Prevalence of Chronic Pain and Inflammatory Disorders

The increasing prevalence of chronic pain and inflammatory conditions such as arthritis, migraines, and fibromyalgia is a major driver of the diclofenac market. The World Health Organization (WHO) estimates that chronic diseases afflict over a billion people worldwide, creating a vast target demographic for diclofenac[3].

Increasing Geriatric Population

The burgeoning geriatric population, which is more susceptible to degenerative joint diseases like osteoarthritis and rheumatoid arthritis, is another pivotal growth driver. This demographic shift increases the demand for effective pain management solutions like diclofenac sodium and misoprostol[3].

Expansion into Emerging Markets

Emerging markets, particularly in the Asia-Pacific and Africa regions, offer lucrative opportunities for the introduction of affordable and effective pain management solutions. These regions are characterized by large populations with unmet medical needs, increasing healthcare spending, and growing awareness of treatment options[3].

Regional Analysis

Asia Pacific

The Asia Pacific region dominates the diclofenac market with a 35.5% share, valued at USD 1.5 billion. This region's growth is propelled by increasing healthcare expenditure, rising awareness of pain management solutions, and expanding healthcare systems in countries like China and India[3].

North America and Europe

North America and Europe are significant players in the diclofenac market, supported by advanced healthcare infrastructure and high awareness of pain management therapies. However, stringent regulatory frameworks and the rising adoption of biologics may slightly temper market growth in these regions[3].

Middle East & Africa and Latin America

These regions are emerging as promising markets for diclofenac, driven by gradual improvements in healthcare infrastructure and growing middle-class populations with access to medical care. While they currently contribute less to the global market, they exhibit potential for high growth[3].

Product Formulations and Preferences

Dosage Forms

Diclofenac sodium and misoprostol are available in various formulations, with tablets being the most common form, holding a 55.5% market share. The combination is often administered in doses of 75 mg diclofenac and 200 mcg misoprostol, taken twice daily with a meal to minimize gastrointestinal side effects[4].

Oral Administration

Oral administration is the preferred method for diclofenac, with 37% of users opting for this route. The combination of diclofenac and misoprostol is designed to be taken orally, with the misoprostol component helping to prevent NSAID-induced gastric and duodenal ulcers[3][4].

Distribution Channels

Retail pharmacies dominate the distribution channels for diclofenac, holding a 68.4% market share. This widespread availability through retail channels ensures easy access to the medication for patients[3].

Financial Implications

The growing demand for diclofenac sodium and misoprostol, driven by the factors mentioned above, translates into significant financial opportunities for pharmaceutical companies. The market's projected growth to USD 6.4 billion by 2033 indicates a robust financial trajectory, with companies likely to invest heavily in research and development to address evolving patient needs and expand their market share[3].

Competitive Landscape

The diclofenac market is shaped by key stakeholders including pharmaceutical companies, healthcare providers, and regulatory bodies. Companies are focusing on product innovation, market expansion, and competitive pricing to maintain their market position. The trend towards generic penetration, especially in regions with cost containment measures, also influences the market dynamics[3].

Regulatory Considerations

Stringent regulatory frameworks, particularly in North America and Europe, play a crucial role in shaping the market. Companies must comply with these regulations to ensure the safety and efficacy of their products. The regulatory landscape also affects the approval and launch of new formulations and generics[3].

Key Takeaways

• The global diclofenac market is projected to grow from USD 4.2 billion in 2023 to USD 6.4 billion by 2033, with a CAGR of 4.3%.
• Asia Pacific dominates the market with a 35.5% share.
• Tablets are the leading dosage form, and oral administration is the preferred method.
• The market is driven by the rising prevalence of chronic pain and inflammatory disorders, an increasing geriatric population, and expansion into emerging markets.
• Retail pharmacies are the primary distribution channels.

FAQs

1. What are the primary indications for diclofenac sodium and misoprostol?

   • Diclofenac sodium and misoprostol are indicated for the acute and chronic treatment of signs and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and acute musculoskeletal disorders[4].

2. What are the potential side effects of diclofenac sodium and misoprostol?

   • Potential side effects include abdominal cramps, pain or discomfort, diarrhea, dizziness, drowsiness, gastrointestinal bleeding, headache, heartburn, high blood pressure, nausea or vomiting, peptic ulcer, swelling of feet, rash, and ringing in the ears[2].

3. Why is misoprostol included in the combination with diclofenac?

   • Misoprostol is included to prevent NSAID-induced gastric and duodenal ulcers, which are common side effects of diclofenac and other NSAIDs[4].

4. Can diclofenac sodium and misoprostol be used during pregnancy?

   • No, misoprostol can cause miscarriage and birth defects, so it should not be taken if you are pregnant[2].

5. What is the recommended dosage for diclofenac sodium and misoprostol?

   • The recommended dosage is typically 75 mg diclofenac and 200 mcg misoprostol, taken twice daily with a meal[4].

Sources

1. pms-DICLOFENAC-MISOPROSTOL Product Monograph.
2. Arthritis Foundation - Diclofenac sodium with misoprostol.
3. Market.us - Diclofenac Market Size, Share, Growth.
4. Pfizer Medical Information - ARTHROTEC® Diclofenac Sodium/Misoprostol Modified Release Tablets.