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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Eryped 200 (2023)

Total Spending

$80K

Total Claims

Beneficiaries

Avg Cost/Unit

$3.35

Spending Trend

$803K(2019)→$1.1M(2019)→$214K(2020)→$211K(2020)→$71K(2021)→$122K(2021)→$79K(2022)→$137K(2022)→$80K(2023)→$76K(2023)

YoY Change:+0.9%

5yr CAGR:-3.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

ARCHIFAR LABInactiveERYTHROMYCIN ETHYLSUCCINATE

DMF 136001998

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

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