Sermorelin acetate - Generic Drug Details

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

Sermorelin acetate is the generic ingredient in one branded drug marketed by Emd Serono and Emd Serono Inc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for sermorelin acetate.

Summary for sermorelin acetate

US Patents:	0
Tradenames:	1
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	25
Patent Applications:	168
DailyMed Link:	sermorelin acetate at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for sermorelin acetate

H01AC	Somatropin and somatropin agonists
H01A	ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

V04CD	Tests for pituitary function
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for sermorelin acetate

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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
Emd Serono	GEREF	sermorelin acetate	INJECTABLE;INJECTION	019863-001	Dec 28, 1990		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Emd Serono Inc	GEREF	sermorelin acetate	INJECTABLE;INJECTION	020443-002	Sep 26, 1997		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Emd Serono Inc	GEREF	sermorelin acetate	INJECTABLE;INJECTION	020443-001	Sep 26, 1997		DISCN	Yes	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 sermorelin acetate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono Inc	GEREF	sermorelin acetate	INJECTABLE;INJECTION	020443-001	Sep 26, 1997	⤷ Sign Up	⤷ Sign Up
Emd Serono	GEREF	sermorelin acetate	INJECTABLE;INJECTION	019863-001	Dec 28, 1990	⤷ Sign Up	⤷ Sign Up
Emd Serono Inc	GEREF	sermorelin acetate	INJECTABLE;INJECTION	020443-002	Sep 26, 1997	⤷ Sign Up	⤷ Sign Up
Emd Serono Inc	GEREF	sermorelin acetate	INJECTABLE;INJECTION	020443-001	Sep 26, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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