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Last Updated: December 22, 2024

MIRALAX Drug Patent Profile


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

Miralax is a drug marketed by Bayer Healthcare Llc and is included in one NDA.

The generic ingredient in MIRALAX is polyethylene glycol 3350. There are four hundred and twenty-one drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350 profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Miralax

A generic version of MIRALAX was approved as polyethylene glycol 3350 by MYLAN on October 6th, 2009.

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Summary for MIRALAX
Drug patent expirations by year for MIRALAX
Drug Sales Revenue Trends for MIRALAX

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Recent Clinical Trials for MIRALAX

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

SponsorPhase
University Hospitals Cleveland Medical CenterPhase 4
Chad R. TracyPhase 4
Indiana UniversityPhase 4

See all MIRALAX clinical trials

Pharmacology for MIRALAX

US Patents and Regulatory Information for MIRALAX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Healthcare Llc MIRALAX polyethylene glycol 3350 FOR SOLUTION;ORAL 022015-001 Oct 6, 2006 OTC Yes Yes ⤷  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

MIRALAX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of MIRALAX

Introduction

MIRALAX, a polyethylene glycol 3350-based laxative, has been a significant player in the gastrointestinal health market since its introduction. Here, we will delve into the market dynamics and financial trajectory of MIRALAX, highlighting its transition from a prescription to an over-the-counter (OTC) product, its market reception, and financial performance.

Transition from Prescription to OTC

In 2007, Schering-Plough Corporation announced that MIRALAX, previously available only by prescription, would be available as an OTC treatment for occasional constipation. This was the first Rx-to-OTC switch in the laxative category in 30 years, marking a significant milestone for the product and the company[1].

Market Reception

The transition to OTC status was well-received by consumers. Nearly 70% of constipated consumers who tried MIRALAX preferred it over their usual laxative. This preference was largely due to MIRALAX's gentle and effective constipation relief without causing uncomfortable side effects like cramps and gas[1].

Product Features and Benefits

MIRALAX works by using the body's own water to gently increase the frequency of bowel movements and soften the stool, making it easier to pass. It is taken once daily and comes in a powder form that dissolves completely in any common beverage. This convenience and ease of use have contributed to its popularity[1].

Availability and Distribution

Following its OTC approval, MIRALAX became widely available at drug stores, grocery stores, mass merchandisers, and club stores across the United States. This broad distribution helped in increasing its accessibility and market reach[1].

Financial Performance

The financial performance of MIRALAX has been robust, particularly after its transition to OTC status. As part of Schering-Plough's portfolio of switched products, MIRALAX contributed significantly to the company's revenue. For instance, Schering-Plough's other switched products, such as CLARITIN, had surpassed $1.5 billion in cumulative U.S. OTC sales since their launch, indicating the potential for substantial revenue from OTC products[1].

Market Trends and Competition

The market for laxatives and gastrointestinal health products is competitive, but MIRALAX has maintained a strong position. The trend towards OTC products has been favorable, with many consumers preferring the convenience and accessibility of over-the-counter treatments. Additionally, the rise of gummy supplements, including gummy versions of laxatives like MIRALAX, has opened new avenues for growth in the market[4].

Consumer Feedback and Market Analysis

Consumer reviews of MIRALAX, including its gummy form, have been mixed but generally positive. Users appreciate its quick relief, delicious flavors, and ease of use, although some have noted higher costs compared to the powder form. Market analyses by firms like Grand View Research indicate that the gummy vitamins and supplements market, including laxatives, is expected to grow significantly in the coming years due to their versatility and ease of use[4].

Impact of Mergers and Acquisitions

Schering-Plough's merger with Merck in 2009 had significant implications for the company's product portfolio, including MIRALAX. The combined entity, Merck & Co., Inc., continued to market and distribute MIRALAX, ensuring its continued presence in the market.

Current Market Position

Today, MIRALAX remains a leading brand in the laxative market. Its strong safety profile, non-habit-forming nature, and effective relief from constipation have made it a preferred choice for many consumers. The product's adaptability, including the introduction of gummy forms, has helped it stay relevant in a market that is increasingly favoring convenient and user-friendly supplements.

Key Takeaways

  • Transition to OTC: MIRALAX's switch from prescription to OTC status in 2007 was a significant market move.
  • Market Reception: The product was well-received by consumers due to its effectiveness and lack of side effects.
  • Financial Performance: MIRALAX has contributed substantially to the revenue of its parent companies.
  • Market Trends: The rise of gummy supplements and OTC products has favored MIRALAX's growth.
  • Consumer Feedback: Mixed but generally positive reviews highlight its effectiveness and convenience.

FAQs

What was the significance of MIRALAX's transition to OTC status?

MIRALAX's transition to OTC status in 2007 was the first Rx-to-OTC switch in the laxative category in 30 years, making it widely available and accessible to consumers without a prescription.

How does MIRALAX work?

MIRALAX works by using the body's own water to gently increase the frequency of bowel movements and soften the stool, making it easier to pass.

What are the benefits of MIRALAX over other laxatives?

MIRALAX is preferred for its gentle and effective constipation relief without causing uncomfortable side effects like cramps and gas.

Is MIRALAX available in different forms?

Yes, MIRALAX is available in both powder and gummy forms, catering to different consumer preferences.

How has the market for gummy supplements impacted MIRALAX?

The growing trend of gummy supplements has opened new avenues for MIRALAX, with gummy versions offering additional convenience and ease of use, contributing to its continued market growth.

Sources

  1. Schering-Plough Corporation MiraLAX(R), Number One Doctor Prescribed Laxative Now Available Over-The-Counter. BioSpace.
  2. Quarterly Statement Third Quarter of 2024. Bayer AG.
  3. Ardelyx, Inc.. Ardelyx.
  4. What's All the Buzz About Miralax Gummy?. NYU Web Publishing.
  5. Sales & Earnings In Brief. Citeline News & Insights.

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