INDOCIN Drug Patent Profile

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

Indocin is a drug marketed by Zyla Life Sciences, Recordati Rare, and Zyla. and is included in five NDAs.

The generic ingredient in INDOCIN is indomethacin sodium. There are fifteen drug master file entries for this compound. Additional details are available on the indomethacin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Indocin

A generic version of INDOCIN was approved as indomethacin sodium by WEST-WARD PHARMS INT on July 16^th, 2008.

Summary for INDOCIN

US Patents:	0
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	22
Patent Applications:	4,351
Drug Prices:	Drug price information for INDOCIN
What excipients (inactive ingredients) are in INDOCIN?	INDOCIN excipients list
DailyMed Link:	INDOCIN at DailyMed

See drug prices for INDOCIN

See drug sales revenues for INDOCIN

Recent Clinical Trials for INDOCIN

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

Sponsor	Phase
Johns Hopkins University	Phase 3
MetroHealth Medical Center	Early Phase 1
National Cancer Institute (NCI)	Phase 2

See all INDOCIN clinical trials

Pharmacology for INDOCIN

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

US Patents and Regulatory Information for INDOCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zyla Life Sciences	INDOCIN	indomethacin	CAPSULE;ORAL	016059-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984		DISCN	Yes	No
Zyla Life Sciences	INDOCIN	indomethacin	CAPSULE;ORAL	016059-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Recordati Rare	INDOCIN	indomethacin sodium	INJECTABLE;INJECTION	018878-001	Jan 30, 1985		DISCN	Yes	No
Zyla	INDOCIN SR	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	018185-001	Feb 23, 1982		DISCN	Yes	No
Zyla	INDOCIN	indomethacin	SUSPENSION;ORAL	018332-001	Oct 10, 1985	AB	RX	Yes	Yes

Expired US Patents for INDOCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984

International Patents for INDOCIN

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

Country	Patent Number	Title	Estimated Expiration
Norway	137880
Australia	472229
Sweden	353657
Sweden	384134	FORFARANDE VID FRAMSTELLNING AV INDOMETACIN INNEHALLANDE SUPPOSITORIER
Netherlands	7014320
Cyprus	760	Indomethacin suppositories
Austria	A846572

INDOCIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Indocin (Indomethacin)

Introduction to Indocin (Indomethacin)

Indocin, also known as indomethacin, is a nonsteroidal anti-inflammatory drug (NSAID) widely used to relieve pain and swelling in patients suffering from arthritis, bursitis, gout, tendonitis, and other inflammatory conditions. It works by blocking substances in the body that cause inflammation, thereby preventing pain and swelling[4].

Market Size and Growth Projections

The indomethacin market, which includes Indocin, has been experiencing significant growth. As of 2023, the global indomethacin market was valued at USD 1.2 billion and is projected to reach USD 2.1 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.5% from 2024 to 2031[3].

Market Segmentation

The indomethacin market is segmented based on several factors:

• Type: Includes indomethacin tablets, capsules, suppositories, oral suspension, and other forms.
• Application: Encompasses pain management, inflammation reduction, gout, rheumatoid arthritis, osteoarthritis, and other uses.
• Geographical Regions: North America, Europe, Asia-Pacific, South America, and Middle-East and Africa[3][4].

Drivers of Market Growth

Several factors are driving the growth of the indomethacin market:

• Increasing Prevalence of Inflammatory Diseases: The rising incidence of gout, arthritis, and other chronic pain conditions is a significant driver.
• Growing Demand for NSAIDs: The need for efficient NSAIDs like indomethacin is increasing due to the expanding healthcare access and global awareness of effective therapies for inflammatory illnesses and chronic pain[3][4].
• Research and Novel Formulations: Continued research and the development of new formulations that improve the safety and efficacy of indomethacin are supporting market expansion[3].

Challenges and Restraints

Despite the growth, the indomethacin market faces several challenges:

• Generic Competition: The entry of generic competitors has significantly impacted the sales of branded indomethacin products like Indocin. For instance, Assertio reported a decline in Indocin sales from $8.7 million in Q1 2024 to $6.9 million in Q2 2024 due to generic competition[2][5].
• Market Dynamics: The market is highly competitive, with various players focusing on organic and inorganic growth strategies such as product launches, acquisitions, and partnerships[4].

Financial Performance of Indocin

Recent Financial Results

Assertio, the company behind Indocin, has reported mixed financial results in recent quarters:

• Decline in Indocin Sales: Indocin sales have been declining due to generic competition. In Q2 2024, Indocin sales dropped to $6.9 million from $8.7 million in Q1 2024[2].
• Adjusted EBITDA: Despite the decline in Indocin sales, Assertio reported an adjusted EBITDA of $5.0 million in Q2 2024, down from $7.4 million in Q1 2024[2].
• Net Loss: The company reported a net loss of $3.7 million in Q2 2024 compared to a net income of $8.5 million in Q2 2023[2].

Future Projections

Assertio has provided guidance for 2024, anticipating:

• Indocin Sales: Net sales of Indocin are expected to range between $18 million to $25 million, reflecting continued pressure from generic competition[5].
• Adjusted EBITDA: The company forecasts adjusted EBITDA to be between $20 million to $30 million for 2024[5].
• Total Net Product Sales: Assertio expects total net product sales to be in the range of $110 million to $125 million, with Rolvedon, another product, contributing significantly to the growth[5].

Impact of Generic Competition

Generic competition has been a significant challenge for Indocin:

• Sales Decline: The entry of generic competitors in August 2023 led to a sharp decline in Indocin sales, both sequentially and year-over-year[5].
• Price and Volume Impact: Generic competition has affected both the volume and pricing of Indocin, leading to reduced sales and margins[2][5].

Strategic Management

Assertio is taking several steps to manage the impact of generic competition:

• Focus on Other Products: The company is focusing on growing other products like Rolvedon, which has shown continued volume growth and is expected to contribute significantly to the company's revenue in 2024[2][5].
• Operational Efficiency: Assertio is working on streamlining its commercial team and managing operating expenses to maintain financial resilience[5].

Regional Market Analysis

The indomethacin market varies across different regions:

• North America and Europe: These regions have a well-established market for indomethacin, driven by high healthcare standards and awareness of NSAIDs.
• Asia-Pacific and Emerging Markets: These regions offer significant growth opportunities due to the growing pharmaceutical industry and increasing healthcare access[3][4].

Competitive Landscape

The indomethacin market is highly competitive, with several key players:

• Product Launches and Approvals: Companies are focusing on launching new products and formulations to stay competitive.
• Acquisitions and Partnerships: Inorganic growth strategies such as acquisitions and partnerships are common in the market[4].

Key Takeaways

• The indomethacin market, including Indocin, is growing due to increasing demand for NSAIDs and the rising prevalence of inflammatory diseases.
• Generic competition is a significant challenge for branded products like Indocin.
• Assertio is managing the impact through focus on other products and operational efficiency.
• The market is expected to continue growing, driven by novel formulations and expanding healthcare access.

FAQs

What is the current market size of the indomethacin market?

The global indomethacin market was valued at USD 1.2 billion in 2023[3].

How is the indomethacin market expected to grow?

The market is expected to reach USD 2.1 billion by 2031, growing at a CAGR of 6.5% from 2024 to 2031[3].

What are the main drivers of the indomethacin market growth?

The main drivers include the increasing prevalence of inflammatory diseases, growing demand for NSAIDs, and the development of novel formulations[3][4].

How has generic competition affected Indocin sales?

Generic competition has led to a significant decline in Indocin sales, affecting both volume and pricing[2][5].

What strategies is Assertio adopting to manage the impact of generic competition?

Assertio is focusing on growing other products like Rolvedon, streamlining its commercial team, and managing operating expenses to maintain financial resilience[5].

Cited Sources:

1. Market Research Intellect - Indometacin (Indomethacin) Market Size, Scope And Forecast Report[1].
2. Stock Titan - Assertio Reports Second Quarter 2024 Financial Results[2].
3. Market Research Intellect - Indomethacin Market Size, Share and Trends [2024-2031][3].
4. The Insight Partners - Indomethacin Market Insights and Growth by 2031[4].
5. Alpha Spread - ASRT Q4-2023 Earnings Call[5].