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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 azithromycin patent protection?

Azithromycin is the generic ingredient in five branded drugs marketed by Pfizer, Pf Prism Cv, Epic Pharma Llc, Lupin Ltd, Pliva, Sandoz, Teva Pharms, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Asi, Mylan Labs Ltd, Sun Pharm Inds Ltd, Teva Parenteral, Oak Pharms Inc, Apotex Corp, Mylan, Teva, and Wockhardt, and is included in forty-six NDAs. There are seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Azithromycin has one hundred and fifty-eight patent family members in fifty-nine countries.

There are thirty-two drug master file entries for azithromycin. Fifty-seven suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for azithromycin

International Patents:	158
US Patents:	7
Tradenames:	5
Applicants:	21
NDAs:	46
Drug Master File Entries:	32
Suppliers / Packagers:	57
Bulk Api Vendors:	50
Clinical Trials:	312
Patent Applications:	7,036
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for azithromycin
DailyMed Link:	azithromycin at DailyMed

Pharmacology for azithromycin

Ingredient-type	Macrolides
Drug Class	Macrolide Antimicrobial

Medical Subject Heading (MeSH) Categories for azithromycin

Anti-Bacterial Agents

Synonyms for azithromycin

(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-(((2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-2-ethyl-3,4,10-trihydroxy-13-(((2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)o

(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-((2S,3R,4S,6R)-

(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyl-tetrahydropyran-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyl-tetrahydropyran-2-yl]oxy-3,5,6,

(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6

(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1

(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-[(2S,3R,4S,6R)-4-dimethylamino-3-hydroxy-6-methyloxan-2-yl]oxy-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-o

(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-{[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy}-2-ethyl-3,4,10-trihydroxy-13-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy}-3,5,6,8,10,12,14-heptameth

(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-((2,6-Dideoxy-3-C-methyl-3-O-methyl-alpha-L-ribo-hexopyranosyl)oxy)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-((3,4,6-trideoxy-3-(dimethylamino)-beta-D-xylo-hexopyranosy

(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-15-oxo-11-{[3,4,6-trideoxy-3-(dimethylamino)-b-D-xylo-hexopyranosyl]oxy}-1-oxa-6-azacyclopentadecan-13-yl 2,6-dideoxy-3-C-methyl-3-O-

(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-15-oxo-11-{[3,4,6-trideoxy-3-(dimethylamino)-beta-D-xylo-hexopyranosyl]oxy}-1-oxa-6-azacyclopentadecan-13-yl 2,6-dideoxy-3-C-methyl-3

(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)13-((2,6-Dideoxy-3-C-methyl-3-O-methyl-alpha-L-ribo-hexopyranosyl)oxy)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-((3,4,6-trideoxy-3-(dimethylamino)-beta-D-xylo-hexopyranosyl

[2R-(2R*,3S*,4R*,5R*,8R*,10R*,11R*,12S*,13S*,14R*)]-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-.alpha.-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-

1-Oxa-6-azacyclopentadecan-15-one, 13-((2,6-dideoxy-3-C-methyl-3-O-methyl-alpha-L-ribo-hexopyranosyl)oxy)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-((3,4,6-trideoxy-3-(dimethylamino)-beta-D-xylo-hexopyranosyl)

104491-80-7

117772-70-0

117772-70-0 (dihydrate)

121470-24-4 (monohydrate)

142556-82-9

24238-EP2295402A2

24238-EP2314590A1

24238-EP2380874A2

83905-01-5

9-Deoxo-9a-aza-9a-methyl-9a-homoerythromycin A

9-Deoxy-9a-aza-9a-methyl-9a-homoerythromycin A

905A015

A-9940

A-9941

AB00698251_11

AB00698251-10

AC-16014

AC1L9KEG

ACT03224

AK144739

AKOS015895044

Aritromicina

Aritromicina [Spanish]

arzomicin

Aycin

Azasite

Azenil

Azifast

Azigram

Azimakrol

aziromycin

Azithromycin (AIDS Initiative)

Azithromycin (anhydrous)

Azithromycin (Zithromax)

Azithromycin [USAN:INN:BAN]

Azithromycin A

azithromycin anhydrous

AZITHROMYCIN DIHYDRATE

Azithromycin for peak identification, European Pharmacopoeia (EP) Reference Standard

Azithromycin for system suitability, European Pharmacopoeia (EP) Reference Standard

Azithromycin hydrate

Azithromycin Identity, United States Pharmacopeia (USP) Reference Standard

Azithromycin Monohydrate

Azithromycin, analytical standard

Azithromycin, Antibiotic for Culture Media Use Only

Azithromycin, European Pharmacopoeia (EP) Reference Standard

Azithromycine

Azithromycine [French]

Azithromycinum

Azithromycinum [Latin]

Azitrocin

Azitromax

Azitromicina

Azitromicina [Spanish]

Azitromicine

Azitromin

Aziwok

AZM

Aztrin

Azyter

Azythromycin

BC204085

BDBM50373918

BIDD:GT0792

Bio-0676

BRN 5387583

BSPBio_002285

BT001059

C38H72N2O12

CAS-83905-01-5

CCG-39360

CCRIS 1961

CHEBI:2955

CHEMBL3736045

CHEMBL529

CP 62993

CP-62993

CP-62993-3

CP62,993

CPD000471864

CS-2308

D03HJK

DB00207

DCH3

DivK1c_000233

DRG-0104

DSSTox_CID_10760

DSSTox_GSID_30760

DSSTox_RID_78858

DTXSID8030760

EBD2198275

EC 617-500-5

GTPL6510

Hemomycin

HMS1922G12

HMS2094M11

HMS2232M10

HMS3259D10

HMS500L15

HSDB 7205

HY-17506

IDI1_000233

J2KLZ20U1M

KBio1_000233

KBio2_000787

KBio2_003355

KBio2_005923

KBio3_001505

KBioGR_000731

KBioSS_000787

LS-1834

MCULE-8817893418

Misultina

Mixoterin

MLS001055353

MLS001066331

MLS001201763

MLS001304005

MLS001332499

MLS001332500

MolPort-002-507-426

MQTOSJVFKKJCRP-BICOPXKESA-N

NC00712

NCGC00090753-01

NCGC00090753-02

NCGC00090753-03

NCGC00090753-04

NCGC00258564-01

NINDS_000233

NSC643732

SAM002589961

SBI-0206706.P001

SCHEMBL23481

Setron

SMR000471864

SPBio_001544

Spectrum_000307

SPECTRUM1503679

Spectrum2_001582

Spectrum3_000653

Spectrum4_000186

Spectrum5_001867

Sumamed

SYN3010

Tobil

Tox21_111008

Tox21_201011

Tromix

Trulimax

UNII-F94OW58Y8V component MQTOSJVFKKJCRP-BICOPXKESA-N

UNII-J2KLZ20U1M

XZ-450

Z-Pak

Z-Pak (Azithromycin)

Z1563146014

Zentavion

Zeto

Zifin

ZINC85537026

ZIT

Zithrax

Zithromac

Zithromax

Zithromax IV

Zithromax, Azithrocin, Azin

Zithromycin

Zitrim

Zitromax

Zitromax Avium 600

Zitrotek

Zmas

Zmax

Zmax SR

Tentative approvals for AZITHROMYCIN

Applicant	Application No.	Strength	Dosage Form
		1%	SOLUTION; OPHTHALMIC
		500MG	INJECTABLE;INJECTION
		200MG/5ML	SUSPENSION;ORAL

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
Wockhardt	AZITHROMYCIN	azithromycin	TABLET;ORAL	065405-001	Feb 11, 2008	AB	RX	No	No
Pfizer	ZITHROMAX	azithromycin	TABLET;ORAL	050711-001	Jul 18, 1996	AB	RX	Yes	No				Y
Oak Pharms Inc	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007		RX	Yes	Yes
Teva	AZITHROMYCIN	azithromycin	TABLET;ORAL	065150-001	Nov 14, 2005	AB	RX	No	No

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Expired US Patents for azithromycin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Oak Pharms Inc	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
Oak Pharms Inc	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007

Non-Orange Book US Patents for azithromycin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,685,958	Quinolone carboxylic acid compositions and related methods of treatment
6,699,492	Quinolone carboxylic acid compositions and related methods of treatment
7,732,415	Topical treatment or prevention of ocular infections
7,749,970	Topical treatment of prevention of ocular infections

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International Patents for azithromycin

Country	Document Number	Estimated Expiration
Guatemala	200400183
Yugoslavia	132588
Czechoslovakia	8804896
Iceland	1540