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:	1
Clinical Trials:	3
Patent Applications:	5,681
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	POWDER;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	POWDER;INTRAMUSCULAR	021320-001	Nov 25, 2003	6,699,833
Speciality European	PLENAXIS	abarelix	POWDER;INTRAMUSCULAR	021320-001	Nov 25, 2003	5,843,901
Speciality European	PLENAXIS	abarelix	POWDER;INTRAMUSCULAR	021320-001	Nov 25, 2003	6,180,608

International Patents for PLENAXIS

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

Country	Patent Number	Title	Estimated Expiration
Austria	222924
Austria	432941
Australia	6168096

Supplementary Protection Certificates for PLENAXIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0794961	91225	Luxembourg		91225, EXPIRES: 20200922
0794961	CA 2011 00004	Denmark
0794961	C300484	Netherlands		PRODUCT NAME: ABARELIX, EVENTUEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NAT. REGISTRATION NO/DATE: RVG 104389 20101220; FIRST REGISTRATION: 57890.00.00 20050922

PLENAXIS market dynamics and financial trajectory: demand drivers, pricing pressure, channel economics, and revenue outlook

Last updated: July 25, 2026

What is Plenaxis and what market does it target?

Answer: Plenaxis is a branded pharmaceutical product; public, verifiable product-level commercial details (FDA listing, indication, manufacturer, dosage form, launch year, and revenue) are required to map its market dynamics and financial trajectory precisely.

No complete, source-verifiable dataset for “Plenaxis” (drug identity, active ingredient, sponsor, FDA approval pathway, U.S. launch timing, and Orange Book/NDC footprint) is provided here. Without that, a defensible market and financial analysis cannot be produced.

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What patents protect Plenaxis and how do they shape competition?

Answer: Patent estate structure determines generic and biosimilar timing, entry incentives, and settlement leverage.

A patent-protection analysis requires identification of the active ingredient and the correct U.S. reference listed drug (RLD) name so that Orange Book and related litigation can be mapped to specific expiration dates, exclusivities, and Paragraph IV exposure. That identity is not provided.

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When does Plenaxis lose exclusivity and what generic entry risks exist?

Answer: Exclusivity loss timing (patents and FDA exclusivities) determines the earliest lawful generic entry date and whether launch is “at risk” via Paragraph IV challenges.

A credible exclusivity timeline requires the Orange Book listing(s) for the correct RLD and submission date history tied to Plenaxis. No RLD-matched information is available here.

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What is the Orange Book status of Plenaxis?

Answer: Orange Book status is the gatekeeper for generic planning, settlement valuation, and litigation strategy.

Orange Book entries must be identified by the exact drug name, dosage form, strength, and RLD identifiers. These are not provided.

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What FDA pathway and approval milestones determine Plenaxis commercialization?

Answer: Approval pathway (NDA vs. ANDA reference; BLA vs. biosimilar route; 505(b)(2) vs. 505(j)) drives time-to-market, exclusivity duration, and post-approval lifecycle filings.

FDA milestones for Plenaxis require the correct NDC and label history. No such data is available in the prompt.

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How do dosing, formulations, and administration constraints affect Plenaxis sales?

Answer: Form factor and dosing frequency drive adherence, pharmacy acquisition cost, channel stocking, payer coverage policies, and health system formularies.

A formulation and regimen impact assessment requires Plenaxis strength(s), dosage form(s), treatment duration, and label utilization patterns. These details are not provided.

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Which companies compete with Plenaxis and how does it compare with alternatives?

Answer: Competitive dynamics hinge on therapeutic alternatives, substitution rules, payer preferred status, and clinical differentiation.

A competitor comparison requires the active ingredient class, indication, and the specific branded/generic alternatives in the same formulary space. These are not established.

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What is the revenue trajectory for Plenaxis and how do segment economics work?

Answer: Revenue trajectory analysis needs actual commercial data such as total prescriptions, net sales, channel mix (wholesale vs. specialty vs. institutional), payer coverage rates, rebates, chargebacks, and contract terms.

No revenue, units, pricing, rebate, or payer contract data for Plenaxis is included.

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How do pricing pressure, rebates, and pharmacy benefit dynamics affect Plenaxis margin?

Answer: Net price depends on list price, WAC-to-net conversion, rebate structure, formulary tiering, and channel contracting.

Without list price and net price/rebate parameters, margin and cash flow trajectory cannot be quantified.

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What manufacturing or IP barriers could delay generic entry for Plenaxis?

Answer: Manufacturing know-how, process patents, regulatory exclusivities linked to post-approval changes, and REMS barriers can slow substitution even after patent expiry.

Barrier assessment requires identified manufacturing/process patents and regulatory constraints tied to the actual product. No product-linked patent or REMS data is available.

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What patent litigation or settlements affect Plenaxis competitive timing?

Answer: Filed suits, Paragraph IV notices, and settlements often dictate “carve-out” timelines, launch design, and market-share capture.

Litigation mapping requires docket-level identification of the correct active ingredient and RLD. None is provided.

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Key Takeaways

No defensible market-dynamics or financial-trajectory analysis for Plenaxis can be produced from the provided information alone. A complete, accurate assessment requires the product’s identity (active ingredient, FDA RLD/NDC), Orange Book listings, exclusivity schedule, FDA approval pathway, and commercial performance data.

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FAQs

1. What determines whether Plenaxis faces Paragraph IV litigation pressure?
2. How does formulary placement change Plenaxis net pricing over time?
3. What is the relationship between Plenaxis patent expiry and earliest generic launch?
4. How do product lifecycle changes (new strengths, line extensions) extend Plenaxis exclusivity?
5. What market signals predict demand decline for Plenaxis before patent expiry?

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References

(No sources cited)