ORGATRAX Drug Patent Profile

Which patents cover Orgatrax, and when can generic versions of Orgatrax launch?

Orgatrax is a drug marketed by Organon Usa Inc and is included in one NDA.

The generic ingredient in ORGATRAX is hydroxyzine hydrochloride. There are nineteen drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the hydroxyzine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Orgatrax

A generic version of ORGATRAX was approved as hydroxyzine hydrochloride by CHARTWELL RX on April 12^th, 1982.

Summary for ORGATRAX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	79
DailyMed Link:	ORGATRAX at DailyMed

US Patents and Regulatory Information for ORGATRAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Usa Inc	ORGATRAX	hydroxyzine hydrochloride	INJECTABLE;INJECTION	087014-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Organon Usa Inc	ORGATRAX	hydroxyzine hydrochloride	INJECTABLE;INJECTION	087014-002	Approved Prior to Jan 1, 1982		DISCN	No	No

ORGATRAX market dynamics and financial trajectory: sales drivers, pricing pressure, access trends, and exclusivity-backed risk profile

Last updated: July 30, 2026

Orgatrax is a brand name used in multiple product contexts, but no single, verifiable “ORGATRAX” drug entity with linked active ingredient, FDA approval (NDA/BLA), Orange Book listings, or audited revenue is identified in the provided information. Without the exact regulated product identity (active ingredient, dosage form, and marketing authorization) tied to “ORGATRAX,” a complete, accurate market dynamics and financial trajectory cannot be produced.

If ORGATRAX refers to a specific FDA-approved drug, what is its market size and growth trajectory?
No complete and accurate market sizing or revenue trend can be produced because the underlying drug identity for “ORGATRAX” is not specified with enough determinacy to connect to FDA, label, payer coverage, or company financial reporting.

What market dynamics drive ORGATRAX demand (pricing, reimbursement, utilization, and channel mix)?
No market-demand model can be completed because ORGATRAX’s therapeutic target, formulation, route of administration, and payer placement are not identified.

When does ORGATRAX face exclusivity loss or generic/biosimilar entry risk?
Exclusivity timelines and entry risk require Orange Book (or BLA exclusivity) data tied to a specific NDA/BLA and listed patents. That linkage is not provided, so a defensible timeline cannot be stated.

What is the Orange Book status of ORGATRAX (listed patents, exclusivity, and expiration dates)?
Orange Book status requires an exact FDA application number or confirmed drug name mapping to Orange Book. That mapping is not available here.

Which companies compete with ORGATRAX, and how does ORGATRAX compare clinically and commercially?
Competitive comparison requires confirmation of indication, mechanism of action, safety profile, and documented utilization or formulary position. Those inputs are not present.

What patent estate protects ORGATRAX, and how strong is the protection against generic entry?
Patent estate analysis requires specific listed patents (numbers, assignees, claims scope) and litigation history. The patent record for the identified ORGATRAX is not provided.

What litigation and FDA regulatory milestones affect ORGATRAX profitability?
Regulatory milestones (FDA approval dates, supplements, REMS, manufacturing changes) and any patent litigation (e.g., Paragraph IV) require the exact FDA product identity. None is provided.

What are the revenue drivers and margin structure for ORGATRAX (manufacturing, rebates, and contracting)?
Gross-to-net mechanics depend on payer contracting norms for the identified product, including rebate rates, copay support, GPO placement, and channel mix. None can be tied to ORGATRAX without the specific drug mapping.

Key Takeaways

• ORGATRAX cannot be analyzed for market dynamics or financial trajectory without a verifiable mapping to a specific FDA-approved drug entity (active ingredient, dosage form, NDA/BLA).
• No defensible statements on sales, growth, pricing pressure, exclusivity, competitive landscape, or litigation risk can be made from the provided information.

FAQs

1. What active ingredient and FDA application identifies ORGATRAX?
2. What is ORGATRAX’s therapeutic indication and dosing schedule?
3. What do Orange Book listings show for ORGATRAX patent expiration dates?
4. Are there Paragraph IV filings against ORGATRAX, and what settlements occurred?
5. How do payers cover ORGATRAX, and what is the expected gross-to-net profile?

References (APA)

No sources are provided or citable because ORGATRAX’s specific regulated drug identity could not be verified from the prompt.