Azithromycin - Generic Drug Details

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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, Hainan Poly, Pliva, Sandoz, Taro, Teva Pharms, Zydus Lifesciences, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Norvium Bioscience, Rising, Slate Run Pharma, Sun Pharm Inds Ltd, Teva Parenteral, Thea Pharma, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Cspc Ouyi, Lupin Ltd, Pharmobedient, Strides Pharma, Sunshine, Teva, Yung Shin Pharm, and Zydus Pharms, and is included in seventy-three NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Azithromycin has fifty-one patent family members in forty-three countries.

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

Summary for azithromycin

International Patents:	51
US Patents:	2
Tradenames:	5
Applicants:	35
NDAs:	73
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	68
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	570
Patent Applications:	6,913
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
Mahidol Oxford Tropical Medicine Research Unit	Phase 2/Phase 3
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit	Phase 2/Phase 3
Medical University of Vienna	N/A

See all azithromycin clinical trials

Generic filers with tentative approvals for AZITHROMYCIN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	1%	SOLUTION; OPHTHALMIC
⤷ Sign Up	⤷ Sign Up	EQ 200MG BASE/5ML	FOR SUSPENSION;ORAL
⤷ Sign Up	⤷ Sign Up	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
Epic Pharma Llc	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	207531-001	Apr 9, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	AZITHROMYCIN	azithromycin	TABLET;ORAL	065193-001	Nov 14, 2005	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex Corp	AZITHROMYCIN	azithromycin	TABLET;ORAL	065507-001	Jul 13, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	AZITHROMYCIN	azithromycin	TABLET;ORAL	211793-001	Jan 27, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	AZITHROMYCIN	azithromycin	TABLET;ORAL	065302-003	Feb 11, 2008	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

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	⤷ Sign Up	⤷ Sign Up
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	⤷ Sign Up	⤷ Sign Up
Pfizer	ZITHROMAX	azithromycin	INJECTABLE;INJECTION	050733-001	Jan 30, 1997	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	ZMAX	azithromycin	FOR SUSPENSION, EXTENDED RELEASE;ORAL	050797-001	Jun 10, 2005	⤷ Sign Up	⤷ Sign Up
Pfizer	ZITHROMAX	azithromycin	TABLET;ORAL	050784-001	May 24, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for azithromycin

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Country	Patent Number	Title	Estimated Expiration
Norway	20043903		⤷ Sign Up
Taiwan	200518784	Azithromycin dosage forms with reduced side effects	⤷ Sign Up
Canada	2467611	FORMES PHARMACEUTIQUES D'AZITHROMYCINE AYANT MOINS D'EFFETS SECONDAIRES (AZITHROMYCIN DOSAGE FORMS WITH REDUCED SIDE EFFECTS)	⤷ Sign Up
Poland	1537859		⤷ Sign Up
New Zealand	535464	Azithromycin dosage forms with reduced side effects	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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