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Azithromycin - Generic Drug Details

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What are the generic drug sources for azithromycin and what is the scope of patent protection?

Azithromycin is the generic ingredient in five branded drugs marketed by Pfizer, Pf Prism Cv, Amneal, Aurobindo Pharma Ltd, Epic Pharma Llc, Lupin Ltd, Pliva, Sandoz, Taro, Teva Pharms, Zydus, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly Pharm, Hikma Pharms, Hospira, Mylan Asi, Mylan Labs Ltd, Sun Pharm Inds Ltd, Teva Parenteral, Akorn, Alembic Pharms Ltd, Apotex Corp, Bionpharma Inc, Cspc Ouyi, Mylan, Sunshine, Teva, Wockhardt, and Yung Shin Pharm, and is included in sixty-seven 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. Fifty-seven 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:	30
NDAs:	67
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	57
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	512
Patent Applications:	6,583
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for azithromycin
Drug Sales Revenues:	Drug sales revenues for azithromycin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for azithromycin
What excipients (inactive ingredients) are in azithromycin?	azithromycin excipients list
DailyMed Link:	azithromycin at DailyMed

See drug prices for azithromycin

See drug sales revenues for azithromycin

Recent Clinical Trials for azithromycin

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

Sponsor	Phase
Iterum Therapeutics, International Limited	Phase 3
Copenhagen Studies on Asthma in Childhood	Phase 2
Waterbury Hospital	Phase 3

See all azithromycin clinical trials

Generic filers with tentative approvals for AZITHROMYCIN

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

Paragraph IV (Patent) Challenges for AZITHROMYCIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
AZASITE	SOLUTION/DROPS;OPHTHALMIC	azithromycin	050810	2011-03-03

US Patents and Regulatory Information for azithromycin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Labs Ltd	AZITHROMYCIN	azithromycin	INJECTABLE;INJECTION	204732-001	Jan 26, 2017		DISCN	No	No
Hospira	AZITHROMYCIN	azithromycin	INJECTABLE;INJECTION	065500-001	Jun 26, 2009	AP	RX	No	No
Lupin Ltd	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	065488-002	May 15, 2015		DISCN	No	No
Cspc Ouyi	AZITHROMYCIN	azithromycin	TABLET;ORAL	208250-001	Apr 17, 2019	AB	RX	No	No
Wockhardt	AZITHROMYCIN	azithromycin	TABLET;ORAL	065302-003	Feb 11, 2008	AB	RX	No	No
Teva	AZITHROMYCIN	azithromycin	TABLET;ORAL	065153-001	Nov 14, 2005		DISCN	No	No
Akorn	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007		RX	Yes	Yes

Expired US Patents for azithromycin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050693-001	Sep 28, 1994
Pfizer	ZITHROMAX	azithromycin	TABLET;ORAL	050730-001	Jun 12, 1996
Pfizer	ZITHROMAX	azithromycin	TABLET;ORAL	050711-001	Jul 18, 1996
Akorn	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007
Pf Prism Cv	ZMAX	azithromycin	FOR SUSPENSION, EXTENDED RELEASE;ORAL	050797-001	Jun 10, 2005
Pfizer	ZITHROMAX	azithromycin	INJECTABLE;INJECTION	050733-001	Jan 30, 1997
Akorn	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007

International Patents for azithromycin

Country	Patent Number	Estimated Expiration
Chile	2004001501
Poland	1537859
Japan	4602711
Peru	20050573
Eurasian Patent Organization	200401216
Tunisia	SN05319
South Korea	100906290