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Last Updated: June 2, 2024

AZITHROMYCIN - Generic Drug Details

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What are the generic 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, 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-three 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:	63
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	560
Patent Applications:	6,071
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
NHS Sunderland Clinical Commissioning Group	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

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
Hospira	AZITHROMYCIN	azithromycin	INJECTABLE;INJECTION	065500-001	Jun 26, 2009	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	AZITHROMYCIN	azithromycin	INJECTABLE;INJECTION	090923-001	Apr 2, 2013	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aci	AZITHROMYCIN	azithromycin	TABLET;ORAL	215773-001	Jul 12, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma Llc	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	207531-002	Apr 9, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hainan Poly	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	217036-001	Jul 27, 2023	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	FOR SUSPENSION;ORAL	050710-002	Oct 19, 1995	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	ZMAX	azithromycin	FOR SUSPENSION, EXTENDED RELEASE;ORAL	050797-001	Jun 10, 2005	⤷ 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	FOR SUSPENSION;ORAL	050710-001	Oct 19, 1995	⤷ 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
Croatia	P20040865	AZITHROMYCIN DOSAGE FORMS WITH REDUCED SIDE EFFECTS	⤷ Sign Up
Japan	2010132700	AZITHROMYCIN DOSAGE FORM WITH REDUCED SIDE EFFECT	⤷ Sign Up
Netherlands	1026315	Azithromycinedoseringsvormen met verminderde bijwerkingen.	⤷ Sign Up
Chile	2004001501	FORMA DE DOSIFICACION ORAL DE AZITROMICINA QUE COMPRENDE (A) AGENTE ALCALINIZANTE Y (B) MULTIPARTICULADOS DE AZITROMICINA Y MONO, DI Y TRIBEHENATO DE GLICERILO; MULTIPARTICULADO DE AZITROMICINA; Y USO DE AZITROMICINA PARA PREPARAR UNA FORMA DE DOSIFI	⤷ Sign Up
China	1697648	Azithromycin dosage forms with reduced side effects	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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