Last Updated: September 24, 2026

Gonadorelin hydrochloride - Generic Drug Details

Name: gonadorelin hydrochloride Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic drug sources for gonadorelin hydrochloride and what is the scope of freedom to operate?

Gonadorelin hydrochloride is the generic ingredient in one branded drug marketed by Hikma and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for gonadorelin hydrochloride

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	9
DailyMed Link:	gonadorelin hydrochloride at DailyMed

Recent Clinical Trials for gonadorelin hydrochloride

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Sponsor	Phase
University of Colorado, Denver	PHASE2
Colorado Clinical & Translational Sciences Institute	PHASE2
Huashan Hospital	N/A

See all gonadorelin hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for gonadorelin hydrochloride

H01CA	Gonadotropin-releasing hormones
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

V04CM	Tests for fertility disturbances
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for gonadorelin hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-002	Sep 30, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>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 gonadorelin hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982	⤷ Start Trial	⤷ Start Trial
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-002	Sep 30, 1982	⤷ Start Trial	⤷ Start Trial
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-002	Sep 30, 1982	⤷ Start Trial	⤷ Start Trial
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-003	Sep 30, 1982	⤷ Start Trial	⤷ Start Trial
Hikma	FACTREL	gonadorelin hydrochloride	INJECTABLE;INJECTION	018123-001	Sep 30, 1982	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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