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, Chartwell Rx, Epic Pharma Llc, Pliva, Sandoz, Taro, Teva Pharms, Zydus, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly Pharm, Hikma, Hospira, Mylan Asi, Rising, Sun Pharm Inds Ltd, Teva Parenteral, Thea Pharma, ACI, Alembic Pharms Ltd, Apotex Corp, Bionpharma Inc, Cspc Ouyi, Lupin Ltd, Mylan, Sunshine, Teva, Wockhardt, and Yung Shin Pharm, and is included in seventy 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-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:	33
NDAs:	70
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	58
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	552
Patent Applications:	5,799
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

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
Rambam Health Care Campus	Phase 2
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
Rajavithi Hospital	N/A

See all azithromycin clinical trials

Generic filers with tentative approvals for AZITHROMYCIN

Applicant	Application No.	Strength	Dosage Form
See Plans and Pricing	See Plans and Pricing	1%	SOLUTION; OPHTHALMIC
See Plans and Pricing	See Plans and Pricing	EQ 200MG BASE/5ML	FOR SUSPENSION;ORAL
See Plans and Pricing	See Plans and Pricing	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
Teva Pharms	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	065419-001	Jun 24, 2008		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Bionpharma Inc	AZITHROMYCIN	azithromycin	TABLET;ORAL	210000-001	Feb 26, 2019	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Pfizer	ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050710-002	Oct 19, 1995	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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	See Plans and Pricing	See Plans and Pricing
Pfizer	ZITHROMAX	azithromycin	FOR SUSPENSION;ORAL	050693-001	Sep 28, 1994	See Plans and Pricing	See Plans and Pricing
Pf Prism Cv	ZMAX	azithromycin	FOR SUSPENSION, EXTENDED RELEASE;ORAL	050797-001	Jun 10, 2005	See Plans and Pricing	See Plans and Pricing
>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
Denmark	1537859		See Plans and Pricing
Poland	1537859		See Plans and Pricing
Germany	602004016444		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.