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Last Updated: March 27, 2025

INDOCIN SR Drug Patent Profile


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Which patents cover Indocin Sr, and when can generic versions of Indocin Sr launch?

Indocin Sr is a drug marketed by Zyla and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Indocin Sr

A generic version of INDOCIN SR was approved as indomethacin by CHARTWELL MOLECULES on August 6th, 1984.

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Summary for INDOCIN SR
Drug patent expirations by year for INDOCIN SR
Recent Clinical Trials for INDOCIN SR

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

SponsorPhase
Johns Hopkins UniversityPhase 3
MetroHealth Medical CenterEarly Phase 1
Janssen Scientific Affairs, LLCPhase 2

See all INDOCIN SR clinical trials

US Patents and Regulatory Information for INDOCIN SR

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Zyla INDOCIN SR indomethacin CAPSULE, EXTENDED RELEASE;ORAL 018185-001 Feb 23, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

International Patents for INDOCIN SR

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

CountryPatent NumberTitleEstimated Expiration
Bulgaria 60753 ⤷  Try for Free
Canada 1149742 LIBERATION ENTRETENUE D'INDOMETHACINE (SUSTAINED RELEASE INDOMETHACIN) ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 2 of 2 entries

Indomethacin Market Dynamics and Financial Trajectory for Indocin SR

Market Introduction

Indomethacin, marketed under the brand name Indocin SR among others, is a nonsteroidal anti-inflammatory drug (NSAID) used to treat various inflammatory conditions such as arthritis, gout, bursitis, and tendonitis. It works by blocking substances in the body that cause inflammation, thereby reducing pain and swelling[1][3].

Market Dynamics

Increasing Prevalence of Inflammatory Conditions

The indomethacin market, including Indocin SR, is driven by the increasing prevalence of gout and arthritis. The rising incidence of these inflammatory diseases has created a significant demand for effective NSAIDs like indomethacin[1][3].

Growing Pharmaceutical Industry

The expansion of the pharmaceutical industry in developing nations is another key factor contributing to the growth of the indomethacin market. This growth opens up new markets and opportunities for the distribution and sale of Indocin SR[1].

Advancements in Drug Formulations

The development of new and improved formulations, such as sustained release and controlled release forms (e.g., Indocin SR and Indos), has enhanced the therapeutic efficacy and patient compliance. These formulations allow for once or twice daily dosing, which is a significant advantage over traditional forms[4].

Financial Trajectory

Recent Financial Performance

Assertio, a company that markets Indocin, reported significant financial improvements in 2022. Net product sales increased by 42%, and adjusted EBITDA increased by 108% due to strategic actions such as refinancing debt, exiting unprofitable sales channels, and acquiring new products like Otrexup and Sympazan. Specifically, Indocin sales increased by 87% due to a shift to more profitable channels and a return to normal customer inventory levels[2].

Quarterly Performance

In the third quarter of 2023, however, the financial performance was less favorable. Indocin net product sales decreased by $4.0 million compared to the prior year quarter, primarily due to competition from generic entrants and compounders. Despite this, the overall net product sales for Assertio remained stable, with the addition of new products like Rolvedon and Sympazan offsetting some of the declines[5].

Market Segmentation

By Product Type

The indomethacin market, including Indocin SR, is segmented by product type into tablets, capsules, suppositories, and other forms. Indocin SR, a sustained release capsule, is a key product in this segment, offering the advantage of prolonged drug release and reduced dosing frequency[1][3].

By Distribution Channel

The market is also segmented by distribution channels, including hospital pharmacies, retail pharmacies, and online pharmacies. The shift to more profitable channels, as seen in Assertio's 2022 financial results, has been a significant factor in the financial trajectory of Indocin SR[1].

Regional Framework

The indomethacin market, including Indocin SR, is analyzed across various regions such as North America, Europe, Asia-Pacific, Middle East and Africa, and South & Central America. Each region is further sub-segmented by country, providing a detailed overview of the market dynamics and growth opportunities in each area[1].

Competitive Landscape

The competitive landscape of the indomethacin market is characterized by several key players focusing on both organic and inorganic growth strategies. Companies are engaging in product launches, acquisitions, and partnerships to expand their market presence. Assertio's acquisition of Otrexup and Sympazan, for example, has been a strategic move to diversify and strengthen its product portfolio[1][2].

Porter’s Five Forces Analysis

  • Buyers' Bargaining Power: The presence of generic entrants and the availability of alternative NSAIDs give buyers some bargaining power, which can impact the pricing and sales of Indocin SR.
  • Suppliers' Bargaining Power: The dependence on a few key suppliers for raw materials and manufacturing can influence the production costs and supply chain stability.
  • Threat of New Entrants: The entry of new generic versions of indomethacin poses a significant threat to branded products like Indocin SR.
  • Threat of Substitutes: The availability of other NSAIDs and alternative treatments for inflammatory conditions can reduce the demand for Indocin SR.
  • Degree of Competition: The market is highly competitive, with several players vying for market share through various strategies[3].

Future Outlook

The indomethacin market, including Indocin SR, is expected to grow at a CAGR of 6.5% from 2024 to 2031, reaching a market size of USD 2.1 billion by 2031. This growth is driven by the increasing incidence of inflammatory diseases, the need for efficient NSAIDs, and the continuous development of novel formulations and therapeutic applications[3].

Key Takeaways

  • The indomethacin market is driven by the increasing prevalence of gout and arthritis.
  • Indocin SR benefits from advancements in sustained release formulations.
  • Assertio's financial performance has been positively impacted by strategic actions and product acquisitions.
  • The market faces competition from generic entrants and alternative treatments.
  • The future outlook is positive, with expected growth driven by increasing demand for NSAIDs.

FAQs

Q: What is Indocin SR used for? Indocin SR is used to treat various inflammatory conditions such as arthritis, gout, bursitis, and tendonitis by reducing pain and swelling.

Q: What are the key factors driving the growth of the indomethacin market? The growth is driven by the increasing prevalence of gout and arthritis, the expanding pharmaceutical industry in developing nations, and the development of new and improved drug formulations.

Q: How has Assertio's financial performance been impacted by Indocin SR sales? Assertio's financial performance has been positively impacted by Indocin SR sales, with an 87% increase in 2022 due to a shift to more profitable channels and a return to normal customer inventory levels.

Q: What are the main challenges faced by Indocin SR in the market? The main challenges include competition from generic entrants, the availability of alternative NSAIDs, and the impact of suppliers' and buyers' bargaining power.

Q: What is the expected market size of the indomethacin market by 2031? The indomethacin market is expected to reach USD 2.1 billion by 2031, growing at a CAGR of 6.5% from 2024 to 2031.

Sources

  1. The Insight Partners - Indomethacin Market Insights and Growth by 2031
  2. Assertio - Fourth Quarter and Full Year 2022 Financial Results
  3. Market Research Intellect - Indomethacin Market Size, Share and Trends [2024-2031]
  4. PubMed - Evaluation of new indomethacin dosage forms
  5. GlobeNewswire - Assertio Reports Third Quarter 2023 Financial Results

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