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Last Updated: December 9, 2019

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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 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, Cspc Ouyi, 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, Bionpharma Inc, Mylan, Sunshine Lake, Teva, and Wockhardt, and is included in sixty-one NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Azithromycin has eighty-one patent family members in forty-three countries.

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

Drug Prices for azithromycin

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

SponsorPhase
University of CopenhagenPhase 4
Patient-Centered Outcomes Research InstitutePhase 3
Allergy- and pulmonary Clinic, Vanloese.Phase 4

See all azithromycin clinical trials

Recent Litigation for azithromycin

Identify potential future generic entrants

District Court Litigation
Case NameDate
Insite Vision Incorporated v. Sandoz, Inc.2013-11-05
INSITE VISION INCORPORATED v. MYLAN PHARMACEUTICALS INC.2013-06-14
INSITE VISION INCORPORATED v. SANDOZ INC.2011-05-26

See all azithromycin litigation

Generic filers with tentative approvals for AZITHROMYCIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1%SOLUTION; OPHTHALMIC
  Start Trial  Start TrialEQ 200MG BASE/5MLFOR SUSPENSION;ORAL
  Start Trial  Start TrialEQ 100MG BASE/5MLFOR 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
Medical Subject Heading (MeSH) Categories for azithromycin
Synonyms for azithromycin
(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-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-(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-
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
AKOS015895044
Aritromicina
Aritromicina [Spanish]
Aycin
Azasite
Azenil
Azifast
Azigram
Azimakrol
Azithramycine
Azithromycin (AIDS Initiative)
Azithromycin (anhydrous)
Azithromycin (Zithromax)
Azithromycin [USAN:INN:BAN]
AZITHROMYCIN DIHYDRATE
Azithromycin for peak identification, European Pharmacopoeia (EP) Reference Standard
Azithromycin for system suitability, European Pharmacopoeia (EP) Reference Standard
Azithromycin Identity, United States Pharmacopeia (USP) Reference Standard
Azithromycin, analytical standard
Azithromycin, Antibiotic for Culture Media Use Only
Azithromycin, European Pharmacopoeia (EP) Reference Standard
Azithromycin,(S)
Azithromycine
Azithromycine [French]
Azithromycinum
Azithromycinum [Latin]
Azitrocin
Azitromax
Azitromicina
Azitromicina [Spanish]
Azitromicine
Azitromin
Aziwok
AZM
Aztrin
Azyter
Azythromycin
BC204085
BDBM50373918
BIDD:GT0792
BRD-K74501079-001-18-1
BRN 5387583
BSPBio_002285
C38H72N2O12
CAS-83905-01-5
CCG-39360
CCRIS 1961
CHEBI:2955
CHEMBL3736045
CHEMBL529
CP 62993
CP 62993; Zithromax
CP-62993
CP-62993-3
CP62,993
CPD000471864
CS-2308
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
SR-05000002067
SR-05000002067-1
SR-05000002067-2
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
Paragraph IV (Patent) Challenges for AZITHROMYCIN
Tradename Dosage Ingredient NDA Submissiondate
AZASITE SOLUTION/DROPS;OPHTHALMIC azithromycin 050810 2011-03-03

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
Sandoz AZITHROMYCIN azithromycin TABLET;ORAL 065211-001 Nov 14, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Pliva AZITHROMYCIN azithromycin TABLET;ORAL 065225-001 Nov 14, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Pfizer ZITHROMAX azithromycin TABLET;ORAL 050730-001 Jun 12, 1996 DISCN Yes No   Start Trial   Start Trial   Start Trial
Cspc Ouyi AZITHROMYCIN azithromycin TABLET;ORAL 208249-001 Oct 25, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd AZITHROMYCIN azithromycin INJECTABLE;INJECTION 090923-001 Apr 2, 2013 AP RX No No   Start Trial   Start Trial   Start Trial
Wockhardt AZITHROMYCIN azithromycin TABLET;ORAL 065405-001 Feb 11, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer ZITHROMAX azithromycin FOR SUSPENSION;ORAL 050710-002 Oct 19, 1995   Start Trial   Start Trial
Oak Pharms Inc AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007   Start Trial   Start Trial
Pf Prism Cv ZMAX azithromycin FOR SUSPENSION, EXTENDED RELEASE;ORAL 050797-001 Jun 10, 2005   Start Trial   Start Trial
Pfizer ZITHROMAX azithromycin INJECTABLE;INJECTION 050733-001 Jan 30, 1997   Start Trial   Start Trial
Pfizer ZITHROMAX azithromycin TABLET;ORAL 050784-001 May 24, 2002   Start Trial   Start Trial
Oak Pharms Inc AZASITE azithromycin SOLUTION/DROPS;OPHTHALMIC 050810-001 Apr 27, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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 verifification 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.