Last Updated: June 24, 2026

Azithromycin - Generic Drug Details

Name: azithromycin Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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

Azithromycin is the generic ingredient in five branded drugs marketed by Pfizer, Pf Prism Cv, Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma Llc, Pliva, Sandoz, Taro, Teva Pharms, Zhejiang Poly Pharm, Zydus Lifesciences, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Pharmobedient, Rising, Slate Run Pharma, Sun Pharm Inds Ltd, Teva Parenteral, Thea Pharma, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Carlsbad, Cspc Ouyi, Extrovis, Lupin, Strides Pharma, Sunshine, Teva, and Zydus Pharms, and is included in seventy-three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for azithromycin. Fifty-nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for azithromycin

US Patents:	0
Tradenames:	5
Applicants:	35
NDAs:	73
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	59
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	603
Patent Applications:	2,908
Drug Prices:	Drug price trends for azithromycin
Drug Sales Revenues:	Drug sales revenues for azithromycin
What excipients (inactive ingredients) are in azithromycin?	azithromycin excipients list
DailyMed Link:	azithromycin at DailyMed

See drug prices for azithromycin

Drug Sales Revenue Trends for azithromycin

See drug sales revenues for azithromycin

Recent Clinical Trials for azithromycin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
DT&CRO	PHASE4
Korea National Institute of Health	PHASE4
Young June Choe	PHASE4

See all azithromycin clinical trials

Generic filers with tentative approvals for AZITHROMYCIN

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	1%	SOLUTION; OPHTHALMIC
⤷ Start Trial	⤷ Start Trial	EQ 200MG BASE/5ML	FOR SUSPENSION;ORAL
⤷ Start Trial	⤷ Start Trial	EQ 100MG BASE/5ML	FOR SUSPENSION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for azithromycin

Drug Class	Macrolide Antimicrobial

Medical Subject Heading (MeSH) Categories for azithromycin

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for azithromycin

J01FA	Macrolides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for AZITHROMYCIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AZASITE	Ophthalmic Solution	azithromycin	1%	050810	1	2011-03-03

US Patents and Regulatory Information for azithromycin

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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
Chartwell Rx	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	065488-001	May 15, 2015	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pliva	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	065246-002	Jul 5, 2006	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sunshine	AZITHROMYCIN	azithromycin	TABLET;ORAL	209043-001	Dec 6, 2018	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hikma	AZITHROMYCIN	azithromycin	INJECTABLE;INJECTION	065265-001	Jan 18, 2007		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Zhejiang Poly Pharm	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	217036-002	Jul 27, 2023	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Teva Pharms	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	065419-001	Jun 24, 2008		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>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 azithromycin

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	7,056,893	⤷ Start Trial
Pfizer	ZITHROMAX	azithromycin	TABLET;ORAL	050711-001	Jul 18, 1996	6,268,489	⤷ Start Trial
Pf Prism Cv	ZMAX	azithromycin	FOR SUSPENSION, EXTENDED RELEASE;ORAL	050797-001	Jun 10, 2005	7,887,844	⤷ Start Trial
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	6,239,113	⤷ Start Trial
Pfizer	ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050710-001	Oct 19, 1995	6,268,489	⤷ Start Trial
Pf Prism Cv	ZMAX	azithromycin	FOR SUSPENSION, EXTENDED RELEASE;ORAL	050797-001	Jun 10, 2005	6,068,859	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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