Viewing data from:

ZITHROMAX

NDA

AZITHROMYCIN | N050711 | PFIZER INC

1 strength0 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

364 trials from ClinicalTrials.gov — 4 recruiting, 8 active, 229 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth NCT00131235	Phase 3	Active	Tampere University	1,320	2003-12 → 2027-12-31
Improving Care Through Azithromycin Research for Infants in Africa NCT04235816	Phase 3	Active	Barcelona Institute for Global Health	20,560	2021-03-15 → 2026-04-30
Kebele Elimination of Trachoma for Ocular Health NCT03335072	Phase 4	Active	University of California, San Francisco	320,000	2022-02-07 → 2028-03-01
Single Dose Azithromycin to Prevent Cholera in Children NCT04326478	Phase 2	Active	Massachusetts General Hospital	920	2021-10-31 → 2026-05-31
Incidence of Acute Laryngeal Injury Following Endotracheal Intubation NCT03250975	Phase 1/2	Active	Vanderbilt University Medical Center	64	2017-08-19 → 2026-12-30
Scrub Typhus Antibiotic Resistance Trial NCT03083197	Phase 4	Active	University of Oxford	177	2017-10-15 → 2028-10
Oral Azithromycin to Prevent Stillbirths and Infant Mortality in Mali NCT03909737	Phase 4	Active	University of Maryland, Baltimore	99,700	2020-09-24 → 2026-03-31
Antibiotic Treatment of Recurrent Episodes of Asthma in Children NCT01233297	Phase 2	Active	Copenhagen Studies on Asthma in Childhood	70	2010-11 → 2033-10
Chronic Airway Disease, Mucus Rheology and Exacerbations NCT04339270	Phase 4	Recruiting	University Hospital, Montpellier	72	2023-02-03 → 2026-02
CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections NCT03236987	Phase 3	Recruiting	Centre Hospitalier Universitaire, Amiens	424	2018-02-05 → 2029-02-05

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$2.07

per ea

Lowest NADAC/Unit

$2.07

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00069306075ZITHROMAX 250 MG Z-PAK TABLET	$2.07	EA	Brand	$0.2777	2025-08-20
00069406101ZITHROMAX 250 MG TABLET	$2.07	EA	Brand	$0.2777	2025-08-20

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 (2 FSS, 2 Big4)

Lowest Price

$10.05

Highest Price

$63.74

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00069-3060-75ZITHROMAX TABLETS	$10.05	FSS	Pfizer Inc.	06/30/2029
00069-3060-75ZITHROMAX TABLETS	$10.05	Big4	Pfizer Inc.	06/30/2029
00069-4061-01ZITHROMAX TABLETS	$63.74	FSS	Pfizer Inc.	06/30/2029
00069-4061-01ZITHROMAX TABLETS	$48.42	Big4	Pfizer Inc.	06/30/2029

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

API Supply Chain24 active DMFs13 inactive

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

TAPI NL BVAZITHROMYCIN MONOHYDRATE

DMF 152612001

TAPI NL BVAZITHROMYCIN DIHYDRATE

DMF 159722002

TAPI NL BVAZITHROMYCIN N

DMF 159852002

ALEMBIC PHARMACEUTICALS LTDAZITHROMYCIN MONOHYDRATE USP

DMF 187192005

JUBILANT BIOSYS LTDAZITHROMYCIN MONOHYDRATE USP

DMF 188682005

ALEMBIC PHARMACEUTICALS LTDAZITHROMYCIN DIHYDRATE USP

DMF 207542007

CSPC OUYI PHARMACEUTICAL CO LTDAZITHROMYCIN

DMF 223312008

ALEMBIC PHARMACEUTICALS LTDAZITHROMYCIN MONOHYDRATE USP (PROCESS-II)

DMF 247542011

LUPIN MANUFACTURING SOLUTIONS LTDAZITHROMYCIN MONOHYDRATE USP (PROCESS B)

DMF 258202012

CALYX CHEMICALS AND PHARMACEUTICALS LTDAZITHROMYCIN MONOHYDRATE

DMF 277132013

MAHIMA LIFE SCIENCES PRIVATE LTDAZITHROMYCIN USP (DIHYDRATE)

DMF 278852013

TARO PHARMACEUTICAL INDUSTRIES LTDAZITHROMYCIN MONOHYDRATE USP

DMF 282942015

HEC PHARM CO LTDAZITHROMYCIN DIHYDRATE NON-STERILE DRUG SUBSTANCE BULK FORM

DMF 288372014

STERILE INDIA PVT LTDAZITHROMYCIN (LYOPHILIZED BULK STERILE)

DMF 299862016

JIANGSU WEIQIDA PHARMACEUTICAL CO LTDAZITHROMYCIN DIHYDRATE

DMF 308872016

JUBILANT BIOSYS LTDAZITHROMYCIN DIHYDRATE USP

DMF 309662016

LUPIN MANUFACTURING SOLUTIONS LTDAZITHROMYCIN DIHYDRATE USP

DMF 334842019

CENTURY PHARMACEUTICALS LTDAZITHROMYCIN DIHYDRATE USP

DMF 345832020

KOPRAN RESEARCH LABORATORIES LTDAZITHROMYCIN DIHYDRATE USP

DMF 348532020

ALEMBIC PHARMACEUTICALS LTDAZITHROMYCIN DIHYDRATE USP (ADF PROCESS)

DMF 350342020

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDAZITHROMYCIN DIHYDRATE

DMF 368952022

CALYX CHEMICALS AND PHARMACEUTICALS LTDAZITHROMYCIN DIHYDRATE

DMF 374102022

HUANGSHI SHIXING PHARMACEUTICAL CO LTDAZITHROMYCIN AMINE DRUG SUBSTANCE INTERMEDIATE

DMF 434742026

ZHEJIANG JINHUA CONBA BIO-PHARM CO LTDAZITHROMYCIN, USP

DMF 438782026

WOCKHARDT LTDInactiveAZITHROMYCIN USP

DMF 144801999

SANDOZ INDUSTRIAL PRODUCTS SAInactiveAZITHROMYCIN MONOHYDRATE (NON-STERILE BULK)

DMF 163902003

ITF CHEMICAL LTDAInactiveAZITHROMYCIN MONOHYDRATE

DMF 170102005

ALEMBIC LTD API DIVInactiveAZITHROMYCIN MONOHYDRATE

DMF 170912003

QUIMICA SINTETICA SAInactiveAZITHROMYCIN HYDROGENCITRATE

DMF 179512004

LUPIN LTDInactiveAZITHROMYCIN MONOHYDRATE USP

DMF 193262006

SHIJIAZHUANG PHARMACEUTICAL GROUP HUASHENG PHARMA CO LTDInactiveAZITHROMYCIN USP (API)

DMF 200742006

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDInactiveAZITHROMYCIN MONOHYDRATE

DMF 202582007

HEC PHARM CO LTDInactiveAZITHROMYCIN MONHYDRATE, NON-STERILE BULK DRUG SUBSTANCE

DMF 208522007

HAINAN POLY PHARMACEUTICAL CO LTDInactiveAZITHROMYCIN GRANULES FOR ORAL SUSPENSION

DMF 234862010

PJ HEALTHCAREInactiveAZITHROMYCIN TASTE MASKING GRANULES 7.5%

DMF 270672013

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveAZITHROMYCIN MONOHYDRATE

DMF 272952013

RUYUAN HEC PHARM CO LTDInactiveAZITHROMYCIN MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE

DMF 284532014

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

Approval Letters

19 letters from Drugs@FDA

Date	Submission	Document
Nov 24, 2021	SUPPL -50	View Letter (PDF)
Apr 24, 2019	SUPPL -47	View Letter (PDF)
Apr 3, 2017	SUPPL -43	View Letter (PDF)
Feb 13, 2017	SUPPL -41	View Letter (PDF)
May 25, 2016	SUPPL -40	View Letter (PDF)
Jun 11, 2014	SUPPL -34	View Letter (PDF)
Feb 21, 2013	SUPPL -36	View Letter (PDF)
Nov 6, 2012	SUPPL -32	View Letter (PDF)
Jun 8, 2012	SUPPL -35	View Letter (PDF)
Feb 3, 2011	SUPPL -31	View Letter (PDF)
Aug 17, 2010	SUPPL -30	View Letter (PDF)
Mar 3, 2009	SUPPL -24	View Letter (PDF)
Nov 8, 2007	SUPPL -19	View Letter (PDF)
Jan 22, 2004	SUPPL -17	View Letter (PDF)
Jan 22, 2004	SUPPL -15	View Letter (PDF)
Dec 22, 2003	SUPPL -16	View Letter (PDF)
Oct 16, 2002	SUPPL -8	View Letter (PDF)
Jul 22, 2002	SUPPL -12	View Letter (PDF)
May 24, 2002	SUPPL -9	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 250MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 18, 1996

No patent or exclusivity listings for this strength.