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Generated: April 21, 2018

DrugPatentWatch Database Preview

Dexamethasone - Generic Drug Details

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What are the generic sources for dexamethasone and what is the scope of dexamethasone patent protection?

Dexamethasone
is the generic ingredient in thirty-two branded drugs marketed by Allergan Herbert, Merck, West-ward Pharms Int, Alpharma Us Pharms, Lyne, Sti Pharma Llc, Vintage Pharms, Wockhardt Bio Ag, Aspen Global Inc, Allergan, Watson Labs, Novartis Pharms Corp, Icon Bioscience, ECR, Fera Pharms Llc, Idt Australia Ltd, Impax Labs, Larken Labs Inc, Par Pharm, Phoenix Labs Ny, Pvt Form, Roxane, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Xspire Pharma, Solvay, Watson Labs Teva, Ucb Inc, Cent Pharms, Abraxis Pharm, Fresenius Kabi Usa, Akorn, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, Teva Parenteral, Wyeth Ayerst, Pharmafair, Alcon, Sola Barnes Hind, Bausch And Lomb, Sandoz Inc, Alcon Pharms Ltd, Novartis, and Perrigo Co Tennessee, and is included in one hundred and twenty-five NDAs. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dexamethasone has one hundred and thirty-seven patent family members in twenty-six countries.

There are thirty-nine drug master file entries for dexamethasone. Thirty-five suppliers are listed for this compound.
Summary for dexamethasone
Pharmacology for dexamethasone
Medical Subject Heading (MeSH) Categories for dexamethasone
Synonyms for dexamethasone
(11|A,16|A)-9-Fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)pregna-1,4-diene-3,20-dione
(11alpha,16alpha)-9-Fluoro-11,17-Dihydroxy-16-Methyl-3,20-Dioxopregna-1,4-Dien-21-Yl Dihydrogen Phosphate
(11beta,16alpha)-9-fluoro-11,17-dihydroxy-16-methyl-3,20-dioxopregna-1,4-dien-21-yl dihydrogen phosphate
(11beta,16alpha)-9-fluoro-11,17-dihydroxy-16-methyl-3,20-dioxopregna-1,4-dien-21-yl phosphate
[2-[(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] dihydrogen phosphate
{2-[(1R,2S,10S,11S,13R,14R,15S,17S)-1-FLUORO-14,17-DIHYDROXY-2,13,15-TRIMETHYL-5-OXOTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADECA-3,6-DIEN-14-YL]-2-OXOETHOXY}PHOSPHONIC ACID
1869-92-7
21-Disodium phosphate dexamethasone
2392-39-4
2BP70L44PR
312-93-6
392D394
3T5
3tc5
54302-EP2305219A1
54302-EP2308562A2
54302-EP2371811A2
55203-24-2
65184-38-5
9-Fluoro-11|A,17,21-trihydroxy-16|A-methylpregna-1,4-diene-3,20-dione 21-Phosphate
9-Fluoro-11beta,17,21-trihydroxy-16alpha-methylpregna-1,4-diene-3,20-dione 21-(dihydrogen phosphate)
9-Fluoro-11beta,17,21-trihydroxy-16alpha-methylpregna-1,4-diene-3,20-dione 21-(dihydrogen phosphate) disodium salt
A816989
A830522
AB1009274
AC-17992
AC1L1SYG
AC1L291E
AC1NTURW
AC1Q1UXS
AI9376Y64P
AJ-46482
AK-51738
Ak-Dex
AK103580
AKOS015896357
AKOS015951212
AKOS016007098
AM84812
AN-14018
AN-40448
AN-50017
AX8235119
Baldex
BC213122
BDBM235670
Betnelan phosphate
C08175
C22H28FNa2O8P
C22H28FO8P.2Na
CAS-2392-39-4
CHEBI:4462
CHEBI:68637
CHEBI:68638
CHEMBL1200637
CHEMBL1201302
CHEMBL2021430
Colvasone
CS-0013899
D00975
D07802
D0NA8U
Dalalone
Dalalone (TN)
Decadron Inhalation, Injection, Ophthalmic Solution and Ointment, and Topical Cream
Decadron phosphate
Decadron-phosphate (TN)
Decdan
Dex 21-P (red blood cell encapsulated), Urbino University/EryDel
Dexabene
Dexadreson
Dexagel
Dexagro
Dexaject SP
Dexamethason sodium phosphate
Dexamethasone 21-(dihydrogen phosphate)
Dexamethasone 21-(disodium phosphate)
Dexamethasone 21-(sodium hydrogen phosphate)
Dexamethasone 21-Dihydrogen Phosphate
Dexamethasone 21-orthophosphate
Dexamethasone 21-phosphate
Dexamethasone 21-phosphate disodium salt
Dexamethasone 21-phosphate disodium salt, >=98%
Dexamethasone disodium phosphate
Dexamethasone Orthophosphate
dexamethasone phosphate
Dexamethasone phosphate disodium
dexamethasone phosphate(2-)
DEXAMETHASONE PHOSPHORIC ACID
DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone sodium phosphate (erythrocyte encapsulated)
Dexamethasone sodium phosphate (erythrocyte encapsulated), Urbino University/EryDel
Dexamethasone sodium phosphate (JAN/USP)
Dexamethasone Sodium Phosphate [USAN:BAN:JAN]
Dexamethasone sodium phosphate [USP:BAN:JAN]
Dexamethasone sodium phosphate for peak identification, European Pharmacopoeia (EP) Reference Standard
Dexamethasone sodium phosphate, European Pharmacopoeia (EP) Reference Standard
Dexamethasone Sodium Phosphate, pharmaceutical secondary standard; traceable to USP, PhEur, BP
Dexamethasone sodium phosphate, United States Pharmacopeia (USP) Reference Standard
Dexamethasone-21-dihydrogen-phosphate
Dexamethasone-21-phosphate
Dexamethasone-21-phosphate disodium salt
dexamethasone;
Dexamethasone21-phosphatedisodiumsalt
DEXAMETHASONESODIUMPHOSPHATE
Dexamethazone sodium phosphate
disodium (1R,2S,10S,11S,13R,14R,15S,17S)-1-fluoro-14,17-dihydroxy-2,13,15-trimethyl-14-[2-(phosphonatooxy)acetyl]tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-3,6-dien-5-one
disodium (1R,2S,10S,11S,13R,14R,15S,17S)-1-fluoro-14,17-dihydroxy-2,13,15-trimethyl-14-[2-(phosphonatooxy)acetyl]tetracyclo[8.7.0.0?,?.0??,??]heptadeca-3,6-dien-5-one
disodium [2-[(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoranyl-10,13,16-trimethyl-11,17-bis(oxidanyl)-3-oxidanylidene-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxidanylidene-ethyl] phosphate
disodium [2-[(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxo-ethyl] phosphate
disodium [2-[(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] phosphate
disodium 9-fluoro-11beta,17-dihydroxy-16alpha-methyl-3,20-dioxopregna-1,4-dien-21-yl phosphate
Disodium dexamethasone phosphate
disodium;[2-[(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] phosphate
DSSTox_CID_27429
DSSTox_GSID_47429
DSSTox_RID_82342
DTXSID2047430
DTXSID3047429
EBD26577
EINECS 206-232-0
EINECS 217-487-2
EINECS 219-243-0
EN300-52795
erydex
FT-0603099
FT-0659571
FT-0666306
Hexadrol Injectable
Hexadrol phosphate
HMS2231O20
HY-B1829A
I06-1906
Intra-erythrocyte dexamethasone (inflammatory diseases), Urbino University/EryDel
J10230
KB-271918
KB-296233
KS-1150
LS-118469
LS-118471
LS-187216
Maxidex Ointment
Megacort
MFCD00079105
Micromethason
MLS000069568
MLS000863280
MLS001076081
MolPort-002-529-303
MolPort-005-937-094
MQRFYYBWKRACSJ-WKSAPEMMSA-M
NCGC00021226-03
NCGC00021226-04
NCGC00094644-01
NCGC00256783-01
Neodecadron
Onadron
Opera_ID_74
Oradexon phosphate
Orgadrone
Phosphoric acid hydrogen (9-fluoro-11beta,17-dihydroxy-16alpha-methyl-3,20-dioxopregna-1,4-dien-21-yl)=sodium ester salt
PL009466
PLCQGRYPOISRTQ-FCJDYXGNSA-L
Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-alpha-methyl-, 21-(dihydrogen phosphate)
Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-alpha-methyl-, 21-(dihydrogen phosphate) disodium salt
Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy- 16-methyl-21-(phosphonooxy)-, (11ss,16?)-
Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11beta,16alpha)-
Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-, sodium salt (1:2), (11beta,16alpha)-
Q-200940
s4028
SC-18764
SCHEMBL135283
SCHEMBL3694078
SCHEMBL7778
SMR000058813
sodium [2-[(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxo-ethyl] hydrogen phosphate
sodium [2-[(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] phosphate
Sodium dexamethasone phosphate
Soldesam
Solu-Decadron
Spersadox
STOCK1N-57166
TL8001979
Tox21_113181
Tox21_302586
UNII-2BP70L44PR
UNII-AI9376Y64P
VQODGRNSFPNSQE-CXSFZGCWSA-N
Wymesone
ZINC3876071

US Patents and Regulatory Information for dexamethasone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs DEXAMETHASONE dexamethasone SUSPENSION/DROPS;OPHTHALMIC 089170-001 May 9, 1989 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Akorn DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 084493-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
West-ward Pharms Int DEXAMETHASONE dexamethasone TABLET;ORAL 087916-001 Aug 26, 1982 BP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Watson Labs DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 087668-001 Jul 1, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for dexamethasone

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
7,090,681 Methods and apparatus for delivery of ocular implants ➤ Try a Free Trial
7,147,644 Apparatus for delivery of ocular implants ➤ Try a Free Trial
7,468,065 Apparatus for delivery of ocular implants ➤ Try a Free Trial
8,242,099 Implants and methods for treating inflammation-mediated conditions of the eye ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for dexamethasone

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0012 France ➤ Try a Free Trial PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
C/GB12/058 United Kingdom ➤ Try a Free Trial PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
C/GB12/047 United Kingdom ➤ Try a Free Trial PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
00552 Netherlands ➤ Try a Free Trial PRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Cantor Fitzgerald
Baxter
Fuji
Boehringer Ingelheim
Farmers Insurance
Teva
US Army
Moodys

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