PLENAXIS Drug Patent Profile

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

Plenaxis is a drug marketed by Speciality European and is included in one NDA.

The generic ingredient in PLENAXIS is abarelix. Additional details are available on the abarelix profile page.

Summary for PLENAXIS

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	3
Patent Applications:	4,209
DailyMed Link:	PLENAXIS at DailyMed

Recent Clinical Trials for PLENAXIS

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

Sponsor	Phase
PRAECIS Pharmaceuticals Inc.	Phase 4
PRAECIS Pharmaceuticals Inc.	Phase 2
Speciality European Pharma Limited	Phase 3

See all PLENAXIS clinical trials

US Patents and Regulatory Information for PLENAXIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003		DISCN	No	No

Expired US Patents for PLENAXIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003	6,455,499
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003	5,843,901
Speciality European	PLENAXIS	abarelix	INJECTABLE;INTRAMUSCULAR	021320-001	Nov 25, 2003	6,699,833

International Patents for PLENAXIS

See the table below for patents covering PLENAXIS around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	9710994	Pharmaceutical formulations for sustained drug delivery
Slovenia	0952843
Israel	180450

Supplementary Protection Certificates for PLENAXIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0794961	91857	Luxembourg		91857, EXPIRES: 20200922
0794961	11C0015	France		PRODUCT NAME: ABARELIX, EVENTUELLEMENT SOUS FORME DE SEL PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE IN FRANCE: 69026150 DU 20101126; REGISTRATION NO/DATE AT EEC: 57890.00.00 DU 20050922
0794961	91225	Luxembourg		91225, EXPIRES: 20200922

PLENAXIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Plenaxis

Introduction to Plenaxis

Plenaxis, also known as abarelix, is a peptide drug developed by Praecis Pharmaceuticals for the treatment of advanced symptomatic prostate cancer. It functions as a gonadotropin-releasing hormone (GnRH) antagonist, designed to suppress testosterone production without the initial testosterone surge associated with GnRH agonists.

Approval and Regulatory History

Plenaxis was approved by the FDA on November 25, 2003, for the palliative treatment of men with advanced symptomatic prostate cancer. However, the approval process was not straightforward. The FDA initially rejected the New Drug Application (NDA) in June 2001 due to concerns over allergic reactions and the maintenance of testosterone suppression. Praecis resubmitted the NDA in February 2003, seeking approval for a defined subpopulation of patients for whom current hormonal therapies were not appropriate[3][5].

Market Positioning

Plenaxis entered a market dominated by other hormonal therapies such as Lupron (TAP Pharmaceuticals), Viadur (Alza), and Zoladex (AstraZeneca). Despite this competition, Plenaxis offered a unique advantage by avoiding the initial testosterone surge, which is a significant concern in prostate cancer treatment[3].

Financial Projections and Sales

Before its approval, Plenaxis was projected to have significant market potential. Analysts at Salomon Smith Barney predicted sales of $120 million for the indication of prostate cancer, while Credit Suisse First Boston forecast peak sales of $1 billion if the drug was also approved for endometriosis. Other analysts at SG Cowen predicted annual sales of $200 million for the first three years, with potential growth to $1 billion if additional indications were approved[3].

However, the actual sales performance of Plenaxis did not meet these lofty projections. The drug faced challenges in gaining market traction, partly due to the delayed approval and the competitive landscape. The financial performance was also impacted by the termination of several licensing agreements, including those with Roche and Amgen, which left Praecis to develop and commercialize the drug on its own[3].

Clinical Trials and Efficacy

The efficacy of Plenaxis was evaluated in several clinical trials. The drug was administered intramuscularly and showed promising results in suppressing serum testosterone levels. In two randomized, open-label, active-comparator trials, Plenaxis demonstrated its ability to avoid testosterone surge and achieve medical castration in a high percentage of patients. However, the effectiveness of testosterone suppression decreased over time, and the drug had some cardiac electrophysiology effects similar to those of LHRH agonists[5].

Market Dynamics

The market dynamics for Plenaxis were influenced by several factors:

Competitive Landscape

Plenaxis faced stiff competition from established GnRH agonists. The delayed approval and the need to establish a new market presence further complicated its market entry[3].

Regulatory Challenges

The FDA's initial rejection and subsequent resubmission process delayed the drug's entry into the market. This delay, combined with the FDA's ongoing monitoring and enforcement issues regarding postmarketing studies, added to the challenges faced by Plenaxis[2][3].

Licensing and Partnerships

The termination of licensing agreements with major pharmaceutical companies like Roche and Amgen left Praecis to handle the development and commercialization alone, which was a significant financial and logistical burden[3].

Financial Trajectory

Given the challenges and the competitive market, the financial trajectory of Plenaxis was not as robust as initially projected. Here are some key points:

Initial Projections vs. Actual Performance

While initial projections suggested significant revenue potential, the actual sales did not meet these expectations. The delayed approval, competitive market, and lack of strong partnerships all contributed to this disparity[3].

Sales Data

As of the available data, there is no detailed annual sales figure provided specifically for Plenaxis. However, the overall performance of the drug was impacted by the factors mentioned above, leading to a less than anticipated financial outcome.

Key Takeaways

• Approval and Regulatory Challenges: Plenaxis faced significant regulatory hurdles, including an initial FDA rejection and subsequent resubmission.
• Market Competition: The drug entered a highly competitive market dominated by established GnRH agonists.
• Financial Projections: Initial sales projections were high, but actual performance did not meet these expectations due to various challenges.
• Clinical Efficacy: Plenaxis demonstrated efficacy in clinical trials but faced issues with long-term testosterone suppression and cardiac electrophysiology effects.

FAQs

1. What is Plenaxis used for? Plenaxis is used for the palliative treatment of men with advanced symptomatic prostate cancer. It functions as a GnRH antagonist to suppress testosterone production.

2. When was Plenaxis approved by the FDA? Plenaxis was approved by the FDA on November 25, 2003.

3. What were the initial sales projections for Plenaxis? Analysts projected sales ranging from $120 million to $1 billion, depending on the indications and market performance.

4. Why did Plenaxis face challenges in the market? Plenaxis faced challenges due to delayed FDA approval, a competitive market, and the termination of licensing agreements with major pharmaceutical companies.

5. How does Plenaxis compare to other GnRH therapies? Plenaxis avoids the initial testosterone surge associated with GnRH agonists but has similar cardiac electrophysiology effects and faces challenges in maintaining long-term testosterone suppression.

Sources

1. Global Peptide Cancer Therapeutics Market (2021 to 2026)

   • https://www.prnewswire.com/news-releases/global-peptide-cancer-therapeutics-market-2021-to-2026---drug-dosage-price--clinical-trials-insight-301248412.html

2. GAO-09-866, New Drug Approval: FDA Needs to Enhance Its ...

   • https://www.gao.gov/assets/a295766.html

3. Abarelix [Abarelix-Depot-F, Abarelix-Depot-M, Abarelix-L, PPI 149, R 3827]

   • https://pubmed.ncbi.nlm.nih.gov/12757402/

4. Natural Products as Sources of New Drugs over the Nearly Four ...

   • https://pubs.acs.org/doi/10.1021/acs.jnatprod.9b01285

5. Plenaxis | FDA

   • https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21320_plenaxis_lbl.pdf