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Last Updated: December 22, 2024

CYTADREN Drug Patent Profile


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When do Cytadren patents expire, and when can generic versions of Cytadren launch?

Cytadren is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in CYTADREN is aminoglutethimide. Additional details are available on the aminoglutethimide profile page.

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

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

SponsorPhase
National Cancer Institute (NCI)Phase 2
Janssen PharmaceuticalsPhase 2
H. Lee Moffitt Cancer Center and Research InstitutePhase 2

See all CYTADREN clinical trials

US Patents and Regulatory Information for CYTADREN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis CYTADREN aminoglutethimide TABLET;ORAL 018202-001 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

Expired US Patents for CYTADREN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis CYTADREN aminoglutethimide TABLET;ORAL 018202-001 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
Novartis CYTADREN aminoglutethimide TABLET;ORAL 018202-001 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

CYTADREN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cytadren

Introduction

Cytadren, also known as aminoglutethimide, is a medication used primarily for the suppression of adrenal function in patients with Cushing’s syndrome and for the treatment of advanced breast cancer. Understanding the market dynamics and financial trajectory of Cytadren involves examining its clinical uses, market positioning, and the economic factors influencing its adoption.

Clinical Uses and Indications

Cytadren is indicated for the suppression of adrenal function in selected patients with Cushing’s syndrome. It reduces the production of glucocorticoids, mineralocorticoids, estrogens, and androgens by inhibiting several steps in steroid synthesis, including the conversion of cholesterol to pregnenolone[3][4].

In the context of breast cancer, Cytadren inhibits the aromatase enzyme, which converts androgens to estrogens, making it an effective treatment for advanced breast cancer in postmenopausal women[4].

Market Positioning

Cytadren is positioned as a niche product within the endocrinology and oncology markets. For Cushing’s syndrome, it is often used as an interim measure until more definitive therapies such as surgery can be undertaken. In breast cancer treatment, it is typically considered a second-line hormonal therapy due to its efficacy in patients who do not respond to other treatments like tamoxifen[3][4].

Competitive Landscape

The market for Cushing’s syndrome treatments is relatively small and specialized, with few drugs specifically targeting this condition. Cytadren competes with other adrenal steroid inhibitors, but its unique mechanism of action and efficacy profile make it a valuable option for certain patients.

In the breast cancer market, Cytadren faces competition from other aromatase inhibitors and hormonal therapies. However, its ability to induce responses in patients who have failed other treatments makes it a significant player in this segment[4].

Financial Trajectory

Historical Context

Cytadren was initially marketed as an anticonvulsant but was withdrawn from this indication in 1966 due to its effects on the adrenal gland. Its subsequent approval for Cushing’s syndrome and breast cancer has been the primary driver of its financial performance.

Revenue and Sales

The revenue generated by Cytadren is modest compared to broader pharmaceutical markets. The drug's niche status and limited patient population contribute to its relatively low sales figures. However, its efficacy and the lack of alternative treatments in certain cases ensure a stable, albeit small, market share.

Pricing and Cost Considerations

The pricing of Cytadren is influenced by its clinical value, the cost of alternative treatments, and the overall healthcare budget constraints. Given its use as a second-line treatment in many cases, it may be subject to pricing pressures and reimbursement challenges.

Carcinogenicity and Safety Concerns

Long-term studies in rats have shown Cytadren to be associated with an increased incidence of neoplasms, which could impact its long-term market viability and financial performance. These findings, although not definitively linked to humans, may influence regulatory scrutiny and patient safety concerns[1][3].

Regulatory Environment

Cytadren is classified under Pregnancy Category D, indicating that it can cause fetal harm if administered during pregnancy. This classification, along with other safety concerns, can affect its market dynamics and financial trajectory by limiting its use in certain patient populations and increasing the scrutiny from regulatory bodies[3].

Patient Population and Demographics

The patient population for Cytadren is relatively small, consisting of patients with Cushing’s syndrome and advanced breast cancer. The demographics of these patients, including age and gender, can influence the drug's market dynamics. For instance, postmenopausal women with breast cancer form a significant segment of the patient population for Cytadren[4].

Economic Impact on Healthcare Systems

Cytadren's economic impact on healthcare systems is multifaceted. While it provides a valuable treatment option for specific conditions, its use must be balanced against the costs of treatment and the potential for adverse effects. The drug's efficacy in reducing cortisol levels and its role in managing advanced breast cancer contribute to its economic value, despite the need for careful patient selection and monitoring[3][4].

Future Outlook

The future outlook for Cytadren is influenced by several factors, including the development of new treatments for Cushing’s syndrome and breast cancer, changes in regulatory environments, and advancements in personalized medicine. While Cytadren remains a valuable treatment option, its market dynamics and financial trajectory will likely be shaped by these external factors.

Potential for Generic Competition

As patents expire, the potential for generic competition could impact Cytadren's market share and revenue. Generic versions of the drug could offer cost savings to healthcare systems, potentially altering the financial trajectory of the branded product.

Emerging Therapies

The development of new therapies for Cushing’s syndrome and breast cancer could challenge Cytadren's market position. Emerging treatments with improved safety profiles or greater efficacy could reduce the demand for Cytadren, affecting its financial performance.

Key Takeaways

  • Niche Market: Cytadren operates in a specialized market segment, targeting patients with Cushing’s syndrome and advanced breast cancer.
  • Clinical Value: The drug's unique mechanism of action and efficacy profile make it a valuable option for certain patients.
  • Regulatory and Safety Concerns: Safety concerns and regulatory classifications can impact its market dynamics and financial trajectory.
  • Economic Impact: Cytadren's use must be balanced against treatment costs and potential adverse effects.
  • Future Outlook: The drug's future is influenced by generic competition, emerging therapies, and changes in regulatory environments.

FAQs

What is Cytadren used for?

Cytadren is used for the suppression of adrenal function in patients with Cushing’s syndrome and for the treatment of advanced breast cancer in postmenopausal women.

How does Cytadren work?

Cytadren inhibits several steps in steroid synthesis, including the conversion of cholesterol to pregnenolone, and blocks the aromatase enzyme, which converts androgens to estrogens.

What are the potential side effects of Cytadren?

Cytadren can cause adrenocortical hypofunction, especially under stress conditions, and is associated with an increased incidence of neoplasms in animal studies.

Is Cytadren safe during pregnancy?

Cytadren is classified under Pregnancy Category D, indicating that it can cause fetal harm if administered during pregnancy.

What is the future outlook for Cytadren?

The future outlook for Cytadren is influenced by potential generic competition, emerging therapies, and changes in regulatory environments.

Sources

  1. FDA Label: Cytadren - accessdata.fda.gov
  2. ACS Journal: Comprehensive and Automated Linear Interaction Energy Based ... - pubs.acs.org
  3. RxList: Cytadren (Aminoglutethimide): Side Effects, Uses, Dosage ... - rxlist.com
  4. E-lactancia: Cytadren - e-lactancia.org
  5. UMSL Student Newspaper: University of Missouri–St. Louis - umsl.edu (Not relevant to the topic)

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