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Last Updated: December 22, 2024

DANOCRINE Drug Patent Profile


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

Danocrine is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in DANOCRINE is danazol. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the danazol profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Danocrine

A generic version of DANOCRINE was approved as danazol by BARR on August 9th, 1996.

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

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

SponsorPhase
Sierra Oncology, Inc.Phase 3
Peking University People's HospitalPhase 1/Phase 2
Mayo ClinicPhase 2

See all DANOCRINE clinical trials

US Patents and Regulatory Information for DANOCRINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us DANOCRINE danazol CAPSULE;ORAL 017557-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us DANOCRINE danazol CAPSULE;ORAL 017557-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us DANOCRINE danazol CAPSULE;ORAL 017557-002 Approved Prior to Jan 1, 1982 DISCN No 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

DANOCRINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Danazol (Danocrine)

Introduction

Danazol, commonly known by the brand name Danocrine, is a synthetic steroid used primarily for hormone-modulating purposes. It is widely used in the treatment of endometriosis, hereditary angioedema, and other hormonal disorders. Here, we will delve into the market dynamics and financial trajectory of Danazol.

Market Size and Projections

The Danazol market has been experiencing significant growth. As of 2023, the market size was valued at USD 35 billion and is projected to reach USD 80 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 7% from 2024 to 2031[1].

Key Drivers of Market Growth

Several factors are driving the growth of the Danazol market:

Increasing Incidence of Target Diseases

The rising incidence of endometriosis and hereditary angioedema globally is a major driver. These conditions are becoming more common, leading to increased demand for effective treatments like Danazol[1].

Advances in Pharmaceutical Research and Development

Continuous research and development in the pharmaceutical sector have enhanced our understanding of Danazol's therapeutic uses. This has led to improved formulations and treatment alternatives, further expanding the market[1].

Improving Healthcare Infrastructure

Enhancements in healthcare infrastructure and increasing healthcare spending have improved patient access to therapies, supporting market expansion. Regulatory approvals and ongoing clinical trials for new indications also contribute to this growth[1].

Market Segmentation

The Danazol market is segmented based on application, product, and geography:

Application

  • Generic Danazol: The generic segment is expected to grow as more patents expire and generic versions become available.
  • Branded Danazol: Branded versions continue to hold a significant market share due to their established reputation and trust among healthcare providers and patients[1].

Product

  • Endometriosis Treatment: This is one of the primary uses of Danazol, and the segment is expected to grow as awareness and diagnosis of endometriosis increase.
  • Hereditary Angioedema Treatment: Danazol is also used to treat hereditary angioedema, another condition that is seeing increased diagnosis and treatment rates[1].

Geography

  • North America: A significant market due to high healthcare spending and advanced medical infrastructure.
  • Europe: Another major market with a high prevalence of target diseases.
  • Asia-Pacific: This region is expected to see rapid growth due to increasing healthcare awareness and spending.
  • South America and Middle-East & Africa: These regions are also growing, driven by improving healthcare access and increasing disease incidence[1].

Competitive Landscape

The Danazol market is competitive with several key players:

  • AbbVie Inc.
  • Teva Pharmaceutical Industries Ltd.
  • Endo International plc
  • Pfizer Inc.
  • Abbott Laboratories
  • Taj Pharmaceuticals Ltd.
  • Akorn Pharmaceuticals
  • Bayer AG
  • Mylan N.V.
  • Gedeon Richter plc
  • Cipla Ltd.[1]

These companies are involved in various market-related activities, including research and development, manufacturing, and distribution.

Financial Performance and Projections

The financial performance of the Danazol market is robust:

  • Revenue Growth: The market is expected to grow from USD 35 billion in 2023 to USD 80 billion by 2031, indicating a strong financial trajectory[1].
  • CAGR: A 7% CAGR from 2024 to 2031 highlights the steady and significant growth anticipated in the market[1].

Regulatory and Clinical Trials

Regulatory approvals and ongoing clinical trials are crucial for the market's expansion. These trials explore new indications for Danazol, ensuring continuous growth in the pharmaceutical industry[1].

Challenges and Risks

While the market is growing, there are several challenges and risks to consider:

  • Competition: The presence of other treatments and the potential for new therapies to emerge poses a competitive risk[3].
  • Regulatory Hurdles: Delays or failures in obtaining regulatory approvals can significantly impact market growth[3].
  • Side Effects and Safety Concerns: Danazol has various side effects, and any adverse safety profiles could affect market demand[4].

Key Takeaways

  • The Danazol market is valued at USD 35 billion as of 2023 and is projected to reach USD 80 billion by 2031.
  • The market is driven by increasing disease incidence, advances in pharmaceutical research, and improving healthcare infrastructure.
  • The market is segmented by application, product, and geography, with key players actively involved in research, manufacturing, and distribution.
  • Regulatory approvals and clinical trials are critical for market expansion.
  • Despite growth, the market faces challenges such as competition, regulatory hurdles, and safety concerns.

FAQs

What is the primary use of Danazol?

Danazol is primarily used for the treatment of endometriosis and hereditary angioedema, as well as for other hormonal disorders.

What is the projected market size of Danazol by 2031?

The Danazol market is expected to reach USD 80 billion by 2031, growing at a CAGR of 7% from 2024 to 2031[1].

Which regions are key markets for Danazol?

North America, Europe, and the Asia-Pacific region are significant markets for Danazol due to high healthcare spending and advanced medical infrastructure[1].

What are the main drivers of the Danazol market growth?

The main drivers include the increasing incidence of target diseases, advances in pharmaceutical research and development, and improvements in healthcare infrastructure[1].

Who are the key players in the Danazol market?

Key players include AbbVie Inc., Teva Pharmaceutical Industries Ltd., Endo International plc, Pfizer Inc., and several others[1].

Sources

  1. Market Research Intellect - Danazol Market Size and Projections
  2. Dana Incorporated - 2023 Record Sales and Profit Growth
  3. Disc Medicine Inc. - 2023 Annual Report
  4. Drug Central - Danazol Drug Card

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