Viewing data from:

E.E.S.

NDA

ERYTHROMYCIN ETHYLSUCCINATE | N050207 | CARNEGIE PHARMACEUTICALS LLC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Relationship Between Gastric Emptying and Glycemic Variability in Type 1 Diabetes Mellitus NCT02755064	Phase 1	Completed	Adil Bharucha	30	2010-06 → 2013-11
Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis NCT01323582	Phase 2	Terminated	University of Florida	26	2009-02 → 2012-12
Patients Response to Early Switch To Oral:Osteomyelitis Study NCT02099240	Early Phase 1	Terminated	Julio Ramirez	11	2014-03-06 → 2018-11-07

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 4 NDCs

Highest NADAC/Unit

$1.73

per ml

Lowest NADAC/Unit

$0.9144

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
52536013013ERYTHROMYCIN 400 MG/5 ML SUSP	$1.73	ML	Generic	—	2026-08-19
52536013613ERYTHROMYCIN 200 MG/5 ML SUSP	$1.53	ML	Generic	—	2026-08-19
52536013213ERYTHROMYCIN 200 MG/5 ML SUSP	$0.9144	ML	Generic	—	2026-08-19
52536013413ERYTHROMYCIN 200 MG/5 ML SUSP	$0.9144	ML	Generic	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$108.68

Highest Price

$200.49

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
24338-0130-13ERY-PED 400MG/5ML SUSP,PWDR,ORAL	$191.13	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026
24338-0132-13ERY-PED 200MG/5ML SUSP,PWDR,ORAL	$108.68	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026
24338-0134-02EES 200MG/5ML SUSP,GRANULES,ORAL	$114.01	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026
24338-0136-10EES 200MG/5ML SUSP,GRANULES,ORAL	$200.49	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain6 active DMFs9 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

ABBVIE INCERYTHROMYCIN ETHYLSUCCINATE

DMF 134431998

ERCROS SAERYTHROMYCIN ETHYLSUCCINATE

DMF 136541998

ALEMBIC PHARMACEUTICALS LTDERYTHROMYCIN ETHYLSUCCINATE USP

DMF 314512017

SM BIOMED SDN BHDERYTHROMYCIN ETHYLSUCCINATE USP

DMF 317542017

CENTURY PHARMACEUTICALS LTDERYTHROMYCIN ETHYLSUCCINATE USP

DMF 345812020

SOLARA ACTIVE PHARMA SCIENCES LTDERYTHROMYCIN ETHYLSUCCINATE USP

DMF 350462020

ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIVInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 132931998

ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIVInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 135111998

POLFAInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 135801998

DSM ANDENO GMBHInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 135811998

GIST-BROCADES NV PHARMACEUTICALSInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 135831998

COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARLInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 135891998

ARCHIFAR LABInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 136001998

FERMIC SA DE CVInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 137111998

SANDOZ INDUSTRIAL PRODUCTS SPAInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 157892001

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Apr 24, 2018	SUPPL -74	View Letter (PDF)
Aug 21, 2017	SUPPL -73	View Letter (PDF)
Feb 6, 2012	SUPPL -71	View Letter (PDF)
Feb 7, 2011	SUPPL -64	View Letter (PDF)
Nov 8, 2010	SUPPL -67	View Letter (PDF)
Dec 19, 2008	SUPPL -68	View Letter (PDF)
May 28, 2008	SUPPL -66	View Letter (PDF)
Jan 9, 2008	SUPPL -65	View Letter (PDF)
Aug 14, 2006	SUPPL -58	View Letter (PDF)
Mar 16, 2004	SUPPL -61	View Letter (PDF)
Apr 25, 2002	SUPPL -57	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 200MG BASE/5ML

RLDAB

0 patents0 exclusivities▴

GRANULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 400MG BASE/5ML

RLDAB

0 patents0 exclusivities▾

GRANULE;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — EQ 200MG BASE/5ML

RLDAB

0 patents0 exclusivities▾

GRANULE;ORAL | Approved: Mar 30, 1987