ARTHROTEC Drug Patent Profile

When do Arthrotec patents expire, and when can generic versions of Arthrotec launch?

Arthrotec is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in ARTHROTEC is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Arthrotec

A generic version of ARTHROTEC was approved as diclofenac sodium; misoprostol by ACTAVIS LABS FL INC on July 9^th, 2012.

Summary for ARTHROTEC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	1
Drug Prices:	Drug price information for ARTHROTEC
What excipients (inactive ingredients) are in ARTHROTEC?	ARTHROTEC excipients list
DailyMed Link:	ARTHROTEC at DailyMed

See drug prices for ARTHROTEC

Recent Clinical Trials for ARTHROTEC

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

Sponsor	Phase
POZEN	Phase 3

See all ARTHROTEC clinical trials

Pharmacology for ARTHROTEC

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

Paragraph IV (Patent) Challenges for ARTHROTEC

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 ARTHROTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-001	Dec 24, 1997	AB	RX	Yes	No
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997	AB	RX	Yes	Yes

Expired US Patents for ARTHROTEC

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
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-001	Dec 24, 1997
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607-002	Dec 24, 1997

International Patents for ARTHROTEC

See the table below for patents covering ARTHROTEC around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	98033	Pharmaceutical compositions including a non-steroidal anti-inflammatory drug and prostaglandin
Ireland	911486
Germany	69109286
Austria	121625

ARTHROTEC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ARTHROTEC

Introduction to ARTHROTEC

ARTHROTEC, a combination of diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID), and misoprostol, a prostaglandin-1 (PGE1) analog, is indicated for the treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications[4].

Market Drivers

Growing Prevalence of Arthritis

The increasing prevalence of arthritis globally is a significant driver for the demand of ARTHROTEC. According to recent data, the prevalence of arthritis is directly proportional to rising age, affecting 53.9% of individuals aged 75 and older[3].

Regulatory Approvals and New Formulations

The market for ARTHROTEC benefits from increasing regulatory approvals and the launch of new formulations. For instance, the diclofenac market, which includes ARTHROTEC, has seen growth due to the introduction of new generics and various administration methods such as oral, parenteral, and topical forms[1].

Protection Against Gastric and Duodenal Ulcers

ARTHROTEC's unique combination of diclofenac and misoprostol provides protection against gastric and duodenal ulcers, making it a preferred choice for patients at high risk of these complications. This added benefit contributes to its market demand[4].

Market Segmentation

By Route of Administration

The market for diclofenac, including ARTHROTEC, is segmented by route of administration into oral, parenteral, and topical. The oral segment, which includes ARTHROTEC, accounts for a significant proportion of the market due to its ease of administration and availability over the counter[1].

By Drug Class

ARTHROTEC falls under the NSAIDs category, which is expected to maintain a substantial share in the rheumatoid arthritis drugs market. The widespread use of NSAIDs for symptomatic relief in rheumatic disorders supports this segment's growth[3].

Regional Market Dynamics

North America

North America is anticipated to hold a significant market share for ARTHROTEC, driven by the high prevalence of arthritis, robust medical infrastructure, and sustained demand from trauma injuries and surgeries. The region's strong healthcare system and high awareness of diclofenac usage further boost the market[1].

Asia-Pacific

While the Asia-Pacific region is not the largest market for ARTHROTEC, it is expected to see significant growth due to the increasing prevalence of arthritis and the entry of smaller market players. This region's growing demand for rheumatoid arthritis treatments will contribute to the overall market expansion[3].

Financial Trajectory

Current Market Size and Forecast

The rheumatoid arthritis drugs market, which includes ARTHROTEC, is estimated to be around USD 56.55 billion in 2024 and is expected to reach USD 75.26 billion by 2029, growing at a CAGR of 5.88% during the forecast period[3].

Pricing and Cost Considerations

The cost for ARTHROTEC (50 mg-200 mcg) oral tablets is around $562 for a supply of 60 tablets, although generic versions are available at a lower cost, starting from $103.81 for 60 tablets. These prices are significant factors in the financial trajectory, as they influence patient affordability and market demand[5].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the market. Initially, there was a decrease in demand and supply of NSAIDs, including ARTHROTEC, in 2020. However, with the relaxation of government restrictions in 2021 and the normalization of supply chains in 2022, the market has returned to pre-pandemic levels and is expected to grow steadily[1].

Challenges and Restraints

Alternative Treatment Options

The market for ARTHROTEC faces challenges from alternative treatment options, such as biologic and targeted synthetic disease-modifying antirheumatic drugs (DMARDs), which have improved clinical outcomes for rheumatoid arthritis patients[2][3].

Patent Expiration

The expiration of patents for branded drugs, including potential generics for ARTHROTEC, can hinder market growth by increasing competition from generic versions[3].

Key Takeaways

• The growing prevalence of arthritis and the increasing geriatric population drive the demand for ARTHROTEC.
• Regulatory approvals and new formulations contribute to market growth.
• The unique combination of diclofenac and misoprostol in ARTHROTEC provides protection against gastric and duodenal ulcers, enhancing its market appeal.
• North America is a significant market for ARTHROTEC due to its high prevalence of arthritis and robust medical infrastructure.
• The market faces challenges from alternative treatment options and patent expirations.

Frequently Asked Questions (FAQs)

1. What is ARTHROTEC used for?

ARTHROTEC is used for the treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications[4].

2. How does ARTHROTEC protect against gastric ulcers?

ARTHROTEC contains misoprostol, which provides protection against gastric and duodenal ulcers by preventing the formation of these ulcers, a common side effect of NSAIDs[4].

3. What are the common side effects of ARTHROTEC?

Common side effects include abdominal pain, diarrhea, dyspepsia, nausea, flatulence, gastritis, vomiting, constipation, headache, and dizziness[4].

4. How much does ARTHROTEC cost?

The cost for ARTHROTEC (50 mg-200 mcg) oral tablets is around $562 for a supply of 60 tablets, although generic versions are available at a lower cost[5].

5. What is the impact of the COVID-19 pandemic on the ARTHROTEC market?

The COVID-19 pandemic initially decreased demand and supply in 2020 but returned to pre-pandemic levels by 2022, with steady growth expected thereafter[1].

Cited Sources:

1. Fortune Business Insights - Diclofenac Market Size, Trends, Growth, 2032
2. PubMed - Economic burden of rheumatoid arthritis: a systematic review
3. Mordor Intelligence - Rheumatoid Arthritis Drugs Market Size (2024 - 2029)
4. Pfizer Medical Information - ARTHROTEC (misoprostol, diclofenac sodium)
5. Drugs.com - Arthrotec Prices, Coupons, Copay Cards & Patient Assistance