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Last Updated: December 22, 2024

AYGESTIN Drug Patent Profile


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

Aygestin is a drug marketed by Duramed Res and is included in one NDA.

The generic ingredient in AYGESTIN is norethindrone acetate. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the norethindrone acetate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Aygestin

A generic version of AYGESTIN was approved as norethindrone acetate by BARR on May 25th, 2001.

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Summary for AYGESTIN
Drug patent expirations by year for AYGESTIN
Recent Clinical Trials for AYGESTIN

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

SponsorPhase
Norton HealthcareN/A
Scott and White Hospital & ClinicPhase 4
Boston Children's HospitalPhase 2

See all AYGESTIN clinical trials

US Patents and Regulatory Information for AYGESTIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Duramed Res AYGESTIN norethindrone acetate TABLET;ORAL 018405-001 Apr 21, 1982 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

AYGESTIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AYGESTIN

Introduction

AYGESTIN, a brand name for norethindrone acetate, is a synthetic progestin used in the treatment of various gynecological conditions, including endometriosis, abnormal uterine bleeding, and secondary amenorrhea. Here, we will delve into the market dynamics and financial trajectory of AYGESTIN, considering its position within the broader endometriosis treatment market.

Market Context: Endometriosis Treatment

The global endometriosis treatment market is experiencing significant growth, driven by factors such as the rising prevalence of endometriosis, increasing awareness about women’s health, and the introduction of novel therapeutic products. The market was valued at USD 1,222.2 million in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 13.52% from 2022 to 2030, reaching USD 3.2 billion by 2030[1].

Segment Analysis: Hormone Therapy

AYGESTIN falls under the hormone therapy segment, which is anticipated to witness a CAGR of 13.99% during the forecast period. Hormone therapies, including oral progestins like AYGESTIN, are commonly used for managing endometriosis-associated symptoms. The segment's growth is fueled by the convenience and effectiveness of oral administration routes, as well as the introduction of new therapeutic products[1].

Route of Administration: Oral Segment

The oral segment dominated the endometriosis treatment market in 2022, accounting for a revenue share of 19.7%. This dominance is due to the common and convenient route of administration for pain killers and hormone therapies, including AYGESTIN. The oral route offers good bioavailability and is effective for managing symptoms associated with endometriosis[1].

Regional Market: North America

North America, particularly the U.S., is a significant market for endometriosis treatments, including AYGESTIN. This region accounted for a revenue share of 48.7% in 2022, driven by the rising prevalence of endometriosis and increasing awareness about women’s health. For instance, in 2021, around 6.5 million women in the U.S. were affected by endometriosis[1].

Competitive Landscape

The endometriosis treatment market is highly competitive, with key players such as Bayer AG, Pfizer, Inc., AbbVie, Inc., and ObsEva SA. These companies are engaged in strategic initiatives like new product launches, collaborations, and mergers and acquisitions to expand their market share. While AYGESTIN is not a new entrant, its continued use and adaptation in treatment protocols keep it relevant in the market[1].

Generic Availability and Impact

AYGESTIN, originally approved by the FDA in 1982, has seen its formulations discontinued over time. However, generic versions of norethindrone acetate are available, which can impact the market dynamics. Generic drugs typically reduce prices and increase competition, but they also ensure continued availability of the medication. For example, generic drug prices fall with the number of competitors, approaching long-run marginal costs when there are eight or more competitors[3][4].

Financial Trajectory

The financial trajectory of AYGESTIN, while not explicitly stated in recent market reports, can be inferred from the broader market trends. As the endometriosis treatment market grows, the demand for hormone therapies, including oral progestins like AYGESTIN, is expected to increase. Here are some key financial indicators:

  • Market Size: The endometriosis treatment market, which includes AYGESTIN, is projected to reach USD 3.2 billion by 2030.
  • Growth Rate: The hormone therapy segment, where AYGESTIN is categorized, is expected to grow at a CAGR of 13.99% during the forecast period.
  • Revenue Share: The oral segment, which dominates the market, is anticipated to maintain its share, contributing significantly to the overall revenue[1].

Challenges and Opportunities

Despite its established presence, AYGESTIN faces challenges such as the introduction of novel treatments and the increasing competition from generic versions. However, its continued use in clinical practice and its inclusion in treatment guidelines present opportunities for sustained market presence.

Side Effects and Safety Considerations

AYGESTIN, like other progestin therapies, comes with potential side effects and safety considerations. These include clinical depression, acne, breast enlargement/tenderness, and thrombotic and thromboembolic events. Healthcare providers must carefully weigh these risks against the benefits when prescribing AYGESTIN[5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of AYGESTIN. Changes in FDA policies, such as increased scrutiny of generic drug applications, can affect the cost and availability of generic versions of norethindrone acetate. This, in turn, can influence the pricing and competition within the market[3].

Key Takeaways

  • The endometriosis treatment market is growing rapidly, driven by increasing prevalence and awareness.
  • Hormone therapy, including AYGESTIN, is a significant segment with a high growth rate.
  • The oral route of administration dominates the market due to its convenience and effectiveness.
  • North America is a key region for endometriosis treatments.
  • Generic availability impacts pricing and competition.
  • Regulatory changes can affect the market dynamics of AYGESTIN.

FAQs

Q: What is AYGESTIN used for? AYGESTIN is used in the treatment of various gynecological conditions, including endometriosis, abnormal uterine bleeding, and secondary amenorrhea.

Q: What is the current market size of the endometriosis treatment market? The global endometriosis treatment market was valued at USD 1,222.2 million in 2022.

Q: What is the expected growth rate of the hormone therapy segment in the endometriosis treatment market? The hormone therapy segment is expected to grow at a CAGR of 13.99% during the forecast period.

Q: Is AYGESTIN available in generic form? Yes, generic versions of norethindrone acetate, the active ingredient in AYGESTIN, are available.

Q: What are some potential side effects of AYGESTIN? Potential side effects include clinical depression, acne, breast enlargement/tenderness, and thrombotic and thromboembolic events.

Sources

  1. Grand View Research - Endometriosis Treatment Market Size & Trends Report, 2030
  2. ASRM - The use of hormonal contraceptives in fertility treatments - A Committee Opinion 2024
  3. Federal Trade Commission - Generic Drug Industry Dynamics
  4. Drugs.com - Generic Aygestin Availability
  5. FDA - AYGESTIN® (norethindrone acetate tablets, USP) Label[1][2][3][4][5]

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