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Azithromycin - Generic Drug Details

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, Amneal Pharms Llc, Aurobindo Pharma Ltd, Epic Pharma Llc, Lupin Ltd, Pliva, Sandoz, Teva Pharms, Zydus Worldwide, Cspc Ouyi Pharm Co, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly Pharm, 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 fifty-four 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. Sixty 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:	24
NDAs:	54
Drug Master File Entries:	32
Suppliers / Packagers:	60
Bulk Api Vendors:	49
Clinical Trials:	337
Patent Applications:	7,004
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for azithromycin
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
➤ Sign Up	➤ Sign Up	1%	SOLUTION; OPHTHALMIC
➤ Sign Up	➤ Sign Up	500MG	INJECTABLE;INJECTION
➤ Sign Up	➤ Sign Up	200MG/5ML	SUSPENSION;ORAL

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
Aurobindo Pharma Ltd	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	209201-002	Oct 9, 2018	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Epic Pharma Llc	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	207531-001	Apr 9, 2018	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Aurobindo Pharma Ltd	AZITHROMYCIN	azithromycin	FOR SUSPENSION;ORAL	209201-001	Oct 9, 2018	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	050693-001	Sep 28, 1994	➤ Sign Up	➤ Sign Up
Oak Pharms Inc	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	➤ Sign Up	➤ Sign Up
Pf Prism Cv	ZMAX	azithromycin	FOR SUSPENSION, EXTENDED RELEASE;ORAL	050797-001	Jun 10, 2005	➤ 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	Document Number	Estimated Expiration
Poland	379984	➤ Sign Up
Canada	2445408	➤ Sign Up
African Intellectual Property Organization (OAPI)	8743	➤ Sign Up
Country	Document Number	Estimated Expiration