Erythromycin ethylsuccinate - Generic Drug Details

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What are the generic sources for erythromycin ethylsuccinate and what is the scope of freedom to operate?

Erythromycin ethylsuccinate is the generic ingredient in twelve branded drugs marketed by Azurity, Amneal Pharms, Ani Pharms, Cadila Pharms Ltd, Endo Operations, Ross Labs, Pharmacia And Upjohn, Arbor Pharms Llc, Alpharma Us Pharms, Dista, Naska, Parke Davis, Pharmafair, Wyeth Ayerst, Aurobindo Pharma Usa, Barr, and Alra, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for erythromycin ethylsuccinate. Eight suppliers are listed for this compound.

Sponsor	Phase
University of Florida	Phase 2
Metabolic Solutions Inc.	Phase 2

Sponsor

Phase

University of Florida

Phase 2

Metabolic Solutions Inc.

Phase 2

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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
Cadila Pharms Ltd	ERYTHROMYCIN ETHYLSUCCINATE	erythromycin ethylsuccinate	GRANULE;ORAL	216212-002	Nov 21, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ross Labs	PEDIAZOLE	erythromycin ethylsuccinate; sulfisoxazole acetyl	GRANULE;ORAL	050529-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cadila Pharms Ltd	ERYTHROMYCIN ETHYLSUCCINATE	erythromycin ethylsuccinate	GRANULE;ORAL	216212-001	Nov 21, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	ERYTHROMYCIN ETHYLSUCCINATE	erythromycin ethylsuccinate	GRANULE;ORAL	062055-001	Approved Prior to Jan 1, 1982	AB	RX	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

US Patents:	0
Tradenames:	12
Applicants:	17
NDAs:	25
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	1
Patent Applications:	8,715
What excipients (inactive ingredients) are in erythromycin ethylsuccinate?	erythromycin ethylsuccinate excipients list
DailyMed Link:	erythromycin ethylsuccinate at DailyMed

Drug Class	Macrolide Antimicrobial Macrolide
Physiological Effect	Decreased Sebaceous Gland Activity