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, Mylan Asi, Rising, Slate Run Pharma, Sun Pharm Inds Ltd, Teva Parenteral, Thea Pharma, ACI, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Cspc Ouyi, Lupin Ltd, Mylan, 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-four 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:	64
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	560
Patent Applications:	6,913
Formulation / Manufacturing:	see details
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
Clinical Hospital Colentina	N/A
Infectious Diseases Clinical Research Consortium	Phase 4
Red Graphic	Phase 4

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
Bionpharma	AZITHROMYCIN	azithromycin	TABLET;ORAL	210001-001	Feb 26, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pf Prism Cv	ZMAX	azithromycin	FOR SUSPENSION, EXTENDED RELEASE;ORAL	050797-001	Jun 10, 2005		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Rising	AZITHROMYCIN	azithromycin	INJECTABLE;INJECTION	204732-001	Jan 26, 2017		DISCN	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
Mylan Asi	AZITHROMYCIN	azithromycin	INJECTABLE;INJECTION	065506-001	Mar 24, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	AZITHROMYCIN	azithromycin	TABLET;ORAL	065398-001	May 15, 2015	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
Pfizer	ZITHROMAX	azithromycin	INJECTABLE;INJECTION	050733-001	Jan 30, 1997	⤷ Sign Up	⤷ Sign Up
Pfizer	ZITHROMAX	azithromycin	TABLET;ORAL	050784-001	May 24, 2002	⤷ Sign Up	⤷ Sign Up
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	⤷ Sign Up	⤷ Sign Up
Pfizer	ZITHROMAX	azithromycin	TABLET;ORAL	050711-001	Jul 18, 1996	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	ZMAX	azithromycin	FOR SUSPENSION, EXTENDED RELEASE;ORAL	050797-001	Jun 10, 2005	⤷ Sign Up	⤷ Sign Up
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	⤷ 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
Slovenia	1537859		⤷ Sign Up
Argentina	045630	FORMAS DE DOSIFICACION DE AZITROMICINA CON EFECTOS SECUNDARIOS REDUCIDOS	⤷ Sign Up
Iceland	7464	Asíþrómýsín lyfjaskammtaform með minni hliðarverkanir	⤷ Sign Up
Iceland	2672		⤷ Sign Up
South Africa	200408075	Azithromycin dosage forms with reduced side effects	⤷ Sign Up
Poland	379984	Postacie dawkowane azytromycyny o zmniejszonym działaniu ubocznym (AZITHROMYCIN DOSAGE FORMS WITH REDUCED SIDE EFFECTS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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