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Last Updated: December 22, 2024

STROMECTOL Drug Patent Profile


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When do Stromectol patents expire, and what generic alternatives are available?

Stromectol is a drug marketed by Merck Sharp Dohme and is included in one NDA.

The generic ingredient in STROMECTOL is ivermectin. There are five drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Stromectol

A generic version of STROMECTOL was approved as ivermectin by EDENBRIDGE PHARMS on October 24th, 2014.

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Summary for STROMECTOL
Drug patent expirations by year for STROMECTOL
Drug Prices for STROMECTOL

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Recent Clinical Trials for STROMECTOL

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

SponsorPhase
Public Health Laboratory Ivo de CarneriPhase 2
Jennifer KeiserPhase 2
Galvita AG, SwitzerlandEarly Phase 1

See all STROMECTOL clinical trials

Pharmacology for STROMECTOL

US Patents and Regulatory Information for STROMECTOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme STROMECTOL ivermectin TABLET;ORAL 050742-002 Oct 8, 1998 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Merck Sharp Dohme STROMECTOL ivermectin TABLET;ORAL 050742-001 Nov 22, 1996 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

STROMECTOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for STROMECTOL (Ivermectin)

Introduction to STROMECTOL (Ivermectin)

STROMECTOL, the brand name for the drug ivermectin, is a semisynthetic anthelmintic agent derived from the avermectins. It is used for the treatment of various parasitic infections, including strongyloidiasis and onchocerciasis[3].

Global Market Size and Growth

The global ivermectin market, which includes STROMECTOL, is projected to experience significant growth over the coming years. As of 2023, the global ivermectin market size was estimated to be around USD 0.31 billion. It is expected to grow to USD 0.49 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 5.2%[1].

Regional Market Insights

  • Global Market: The global market for ivermectin is forecasted to reach USD 213.7 million by 2030, growing at a CAGR of 7.3% from 2024 to 2030[4].
  • European Market: While specific figures for the European market in 2023 are not provided, it is part of the broader global trend that sees significant growth in the use and demand for ivermectin[4].

Key Drivers of the Market

Several factors are driving the growth of the ivermectin market:

  • Increased Awareness of Animal Health: Growing awareness about animal health and the need for effective treatments against parasitic infections are significant drivers[1].
  • Technological Advancements: Continuous technological developments and advancements in pharmaceutical manufacturing are also contributing to the market's growth[1].

Competitive Landscape

The ivermectin market is dominated by several key players:

  • MERCK: As the original developer of STROMECTOL, MERCK remains a major player in the market[1][4].
  • Hovione: Known for its pharmaceutical manufacturing capabilities, Hovione is another significant player[1].
  • Zhejiang Hisun Pharmaceutical: This Chinese pharmaceutical company is also a major competitor[1].
  • Dr. Reddy's Laboratories: With the recent launch of a generic version of ivermectin, Dr. Reddy's is entering the market as a strategic player[2].

Market Opportunity in the US

The US market for ivermectin tablets, including both branded and generic products, is substantial. As of September 2024, this market had sales of approximately $20 million over the preceding 12 months. The entry of generic manufacturers like Dr. Reddy's and Senores Pharmaceuticals is expected to increase competition and potentially expand market reach[2].

Financial Impact of Generic Entries

The launch of generic ivermectin by companies like Dr. Reddy's and Senores Pharmaceuticals represents a modest but strategic opportunity. These generic entries can reduce costs for consumers and increase market penetration, thereby contributing to the overall growth of the ivermectin market.

Clinical Indications and Usage

STROMECTOL is indicated for the treatment of several parasitic infections:

  • Strongyloidiasis: It is effective in treating intestinal strongyloidiasis with a high cure rate following a single dose[3].
  • Onchocerciasis: It is used to treat onchocerciasis, a disease caused by the nematode parasite Onchocerca volvulus, based on extensive clinical trials[3].

Safety Profile

The safety profile of STROMECTOL includes potential side effects such as Mazzotti reactions, which can include symptoms like arthralgia, lymph node enlargement, and pruritus. Other adverse reactions may include facial edema, peripheral edema, and orthostatic hypotension[3].

Economic Impact of Misuse

There have been instances of wasteful spending on ivermectin prescriptions, particularly during the COVID-19 pandemic. For example, in the week of August 13, 2021, private and Medicare plans paid an estimated $2.5 million for ivermectin prescriptions for COVID-19, which extrapolates to $129.7 million annually. This highlights the need for appropriate use and prescribing practices to avoid unnecessary economic burden[5].

Future Outlook

The future of the ivermectin market looks promising, driven by increasing demand for effective parasitic treatments and the entry of new generic manufacturers. As the market continues to grow, it is expected to reach new heights, both in terms of revenue and market penetration.

Key Takeaways

  • The global ivermectin market is projected to grow from USD 0.31 billion in 2023 to USD 0.49 billion by 2032.
  • Key drivers include increased awareness of animal health and technological advancements.
  • Major players in the market include MERCK, Hovione, and Dr. Reddy's Laboratories.
  • The US market for ivermectin tablets is valued at approximately $20 million annually.
  • STROMECTOL is indicated for treating strongyloidiasis and onchocerciasis with a robust safety profile.
  • Misuse of ivermectin can lead to significant economic waste.

FAQs

Q: What is the expected market size of the ivermectin market by 2032? A: The ivermectin market is expected to touch USD 0.49 billion by 2032[1].

Q: What is the CAGR of the ivermectin market from 2023 to 2032? A: The ivermectin market is expected to exhibit a CAGR of 5.2% during this period[1].

Q: Which companies are the key players in the ivermectin market? A: Key players include MERCK, Hovione, Zhejiang Hisun Pharmaceutical, Hangzhou Think Chemical, and Shandong Qilu King-Phar Pharmaceutical[1].

Q: What is the current market size of ivermectin tablets in the US? A: The market for ivermectin tablets in the US had sales of approximately $20 million over the 12 months ending in September 2024[2].

Q: What are the primary indications for STROMECTOL? A: STROMECTOL is indicated for the treatment of strongyloidiasis and onchocerciasis[3].

Sources

  1. Business Research Insights: Ivermectin Market Size, Share, Growth, Trends, Report, 2032.
  2. Stock Titan: Dr. Reddy's Launches Ivermectin Generic in $20M US Market.
  3. FDA: STROMECTOL® - accessdata.fda.gov.
  4. Valuates Reports: Ivermectin - Market, Report Size, Worth, Revenue, Growth, Industry.
  5. JAMA Network: US Insurer Spending on Ivermectin Prescriptions for COVID-19.

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