Gonadorelin hydrochloride - Generic Drug Details

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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:	8
Patent Applications:	6,707
DailyMed Link:	gonadorelin hydrochloride at DailyMed

Recent Clinical Trials for gonadorelin hydrochloride

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

Sponsor	Phase
Huashan Hospital	N/A
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Early Phase 1
Los Angeles Biomedical Research Institute	Early Phase 1

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

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