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Generated: September 18, 2019

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Alendronate sodium - Generic Drug Details

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What are the generic sources for alendronate sodium and what is the scope of alendronate sodium freedom to operate?

Alendronate sodium is the generic ingredient in four branded drugs marketed by West-ward Pharms Int, Merck, Mission Pharma, Apotex, Aurobindo Pharma, Cipla, Hangzhou Binjiang, Impax Labs Inc, Jubilant Cadista, Mylan, Neopharma, Sun Pharm, Teva Pharms, Upsher Smith Labs, Watson Labs, and Merck And Co Inc, and is included in eighteen NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alendronate sodium has one hundred and two patent family members in forty countries.

There are twenty-five drug master file entries for alendronate sodium. Twenty-six suppliers are listed for this compound.

Pharmacology for alendronate sodium
Drug ClassBisphosphonate
Medical Subject Heading (MeSH) Categories for alendronate sodium
Synonyms for alendronate sodium
(4-amino-1-hydroxy-1-phosphono-butyl)phosphonic acid
(4-AMINO-1-HYDROXY-1-PHOSPHONOBUTYL)PHOSPHONIC ACI
(4-amino-1-hydroxy-1-phosphonobutyl)phosphonic acid
(4-Amino-1-hydroxy-1-phosphonobutyl)phosphonic Acid Monosodium Salt
(4-amino-1-hydroxybutane-1,1-diyl)bis(phosphonic acid)
(4-amino-1-hydroxybutane-1,1-diyl)bisphosphonic acid
(4-Amino-1-hydroxybutane-1,1-diyl)diphosphonic acid
(4-Amino-1-Hydroxybutylidene)-Bisphosphonic Acid
(4-Amino-1-hydroxybutylidene)bisphosphonic acid
(4-Amino-1-hydroxybutylidene)bisphosphonic acid monosodium salt
(4-Amino-1-hydroxybutylidene)diphosphonic acid
(4-azanyl-1-oxidanyl-1-phosphono-butyl)phosphonic acid
121268-17-5
121268-17-5 (mono-hydrochloride salt, trihydrate)
129318-43-0
129318-43-0 (anhyd.)
1yhm
2UY4M2U3RA
376A361
4-AMINO-1-HYDROXY-1-PHOSPHONOBUTYL PHOSPHONIC ACID
4-Amino-1-hydroxy-1-phosphonobutyl phosphonic acid monosodium trihydrate
4-amino-1-hydroxy-1-phosphonobutyl phosphonic acid, monosodium
4-Amino-1-hydroxy-1,1-butylidinediphosphonic acid
4-Amino-1-hydroxybutane-1,1-diphosphonate
4-Amino-1-hydroxybutane-1,1-diphosphonic Acid
4-amino-1-hydroxybutane-1,1-diyldiphosphonic acid
4-Amino-1-hydroxybutylidene-1,1-bis(phosphonic acid)
4-Amino-1-hydroxybutylidene-1,1-bisphosphonate
4-amino-1-hydroxybutylidene-bisphosphonic acid
4-Amino-1-hydroxybutylidine-1,1-bisphosphonate
4-amino-1,1-diphosphonobutan-1-ol
4988K7X26P
66376-36-1
66376-36-1 (Parent)
68549-EP2270008A1
68549-EP2292617A1
68549-EP2295426A1
68549-EP2295427A1
68549-EP2308855A1
70013-EP2292592A1
70013-EP2295409A1
70013-EP2305640A2
70013-EP2308479A2
A805927
A835441
AB0008472
AB0013933
AB01274863-01
AB09896
AB10152
ABDP
AC-8070
AC1L1CW3
AC1Q1W16
AC1Q1W17
Acide alendronique
Acide alendronique [INN-French]
Acido alendronico
Acido alendronico [INN-Spanish]
Acidum alendronicum
Acidum alendronicum [INN-Latin]
Adronat
AHBuBP
AHButBP
AHD
AJ-74282
AK117216
AK117569
AKOS001015793
AKOS015895071
AKOS015960820
AKOS016010492
Alend
alendronate
Alendronate (Fosamax)
Alendronate (sodium hydrate)
Alendronate acid
ALENDRONATE MONOSODIUM SALT TRIHYDRATE
Alendronate monosodium trihydrate
Alendronate sodium (USAN)
Alendronate sodium [USAN:USP]
Alendronate sodium [USAN]
Alendronate sodium anhydrous
Alendronate sodium hydrate
Alendronate sodium hydrate (JP17)
ALENDRONATE SODIUM SALT TRIHYDRATE
Alendronate sodium trihydrate
Alendronate sodium trihydrate, >=97% (NMR), powder
Alendronate Sodium, Pharmaceutical Secondary Standard; Certified Reference Material
Alendronate sodium, United States Pharmacopeia (USP) Reference Standard
Alendronate, Sodium Salt
Alendronate, Sodium, Trihydrate
ALENDRONIC ACID
Alendronic acid (INN)
Alendronic acid [INN:BAN]
Alendronic Acid Monosodium Salt
Alendronic acid sodium salt
Alendronic acid, Sodium aldendronate
Alendros
Almerol
Aminohydroxybutylidene biphosphonate monosodium salt trihydrate
AN-32438
AN-38504
AN-8360
ANW-43155
ANW-43156
API0001401
API0005892
Arendal
AS-10963
Avalent
AX8002169
AX8041220
BB_SC-02791
BCP22746
BDBM25313
BG0020
BIDD:GT0180
Binosto
Binosto (TN)
bisphosphonate
bisphosphonate, 65
Bonalon
BPH 1
BRD-K75527158-323-01-3
C-15277
C07752
C4H12NNaO7P2
C4H13NO7P2
C4H18NNaO10P2
CAKRAHQRJGUPIG-UHFFFAOYSA-M
CAS-121268-17-5
CC-00619
CCG-220631
CHEBI:2566
CHEBI:2567
CHEMBL2367465
CHEMBL675
CHEMBL870
CS-0431
CTK8B3778
CTK8B3779
D00939
D07119
DB00630
DCSBSVSZJRSITC-UHFFFAOYSA-M
Dronal
DS-2820
DSSTox_CID_27778
DSSTox_GSID_47801
DSSTox_RID_82554
DTXSID5022568
DTXSID7047801
Elandor
EX-101
Fosalan
Fosamac
Fosamax
Fosamax (TN)
FT-0601586
FT-0641064
G-704,650
G-704650
GP1402
GTH-42
GTH-42J
GTH-42V
GTH-42W
GTPL3141
HMS3604I12
HMS3713P04
HSCI1_000337
HSDB 7990
HY-11101
Hydrogen (4-amino-1-hydroxy-1-phosphonobutyl)phosphonate (Na+)
I04-9842
I06-0478
I914
Indrol
J-005667
J10154
J10298
KS-00000L1S
KS-1028
L-670452
LS-106421
LS-106423
LS-106424
M-1609
MER-103
MFCD00868112
MFCD01748233
MFCD01748233 (97%)
MK 217
MK-0217
MK-217
Monosodium (4-Amino-1-hydroxy-1-phosphonobutyl)phosphonate
Monosodium (4-amino-1-hydroxybutylidene)bisphosphonate trihydrate
Monosodium alendronate
NCGC00096054-01
NCGC00096054-03
NCGC00096054-04
NCGC00263967-02
NeoBon
OGSPWJRAVKPPFI-UHFFFAOYSA-N
Onclast
Oprea1_422906
Osteovan
P,P'-(4-Amino-1-hydroxybutylidene)bis-phosphonic acid monosodium salt
P,P'-(4-Amino-1-hydroxybutylidene)bisphosphonic acid
Phosphonic acid, (4-amino-1-hydroxybutylidene)bis
Phosphonic acid, (4-amino-1-hydroxybutylidene)bis-
Phosphonic acid, (4-amino-1-hydroxybutylidene)bis-, monosodium salt
Phosphonic acid, (4-amino-1-hydroxybutylidene)bis-, monosodium salt, trihydrate
Q-200606
Q-200607
RTR-003482
SBI-0206778.P001
SC-17297
SC-22170
SC-45997
SCHEMBL18898
SCHEMBL328770
sodium (4-amino-1-hydroxy-1-phosphono-butyl)-hydroxy-phosphinate
sodium (4-amino-1-hydroxy-1-phosphono-butyl)-hydroxy-phosphinate trihydrate
sodium (4-amino-1-hydroxy-1-phosphonobutyl)-hydroxyphosphinate
sodium (4-azanyl-1-oxidanyl-1-phosphono-butyl)-oxidanyl-phosphinate
Sodium alendronate
Sodium alendronate hydrate
SODIUM ALENDRONATE TRIHYDRATE
Sodium alendronate trihydrate, European Pharmacopoeia (EP) Reference Standard
sodium alendronate(1-)
sodium hydrogen (4-amino-1-hydroxy-1-phosphonobutyl)phosphonate trihydrate
sodium hydrogen-4-amino-1-hydroxy-1-phosphonobutylphosphonate
sodium hydrogen(4-amino-1-hydroxy-1-phosphonobutyl)phosphonate
sodium trihydrate alendronate(1-)
sodium trihydrate hydrogen (4-amino-1-hydroxy-1-phosphonobutyl)phosphonate
Sodium trihydrogen (4-amino-1-hydroxybutylidene)diphosphonate, trihydrate
sodium trihydrogen 4-amino-1-hydroxybutylidenediphosphonate trihydrate
sodium;(4-amino-1-hydroxy-1-phosphonobutyl)-hydroxyphosphinate;trihydrate
SPECTRUM1505166
SR-05000001906
SR-05000001906-1
ST24034598
ST2412625
ST50036159
Steovess
SY070842
Teiroc
TL8000566
Tox21_111553
Tox21_111553_1
TR-003482
UNII-2UY4M2U3RA
UNII-4988K7X26P
UNII-X1J18R4W8P
VZ20111
X1J18R4W8P
Y-8756
Z56771118
ZINC3801919

US Patents and Regulatory Information for alendronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jubilant Cadista ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 090557-001 Feb 18, 2010 AB RX No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Mission Pharma BINOSTO alendronate sodium TABLET, EFFERVESCENT;ORAL 202344-001 Mar 12, 2012 RX Yes Yes   Try a Free Trial   Try a Free Trial Y Y   Try a Free Trial
Cipla ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 076768-004 Aug 4, 2008 AB RX No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Sun Pharm ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 090022-001 Sep 10, 2008 AB RX No No   Try a Free Trial   Try a Free Trial   Try a Free Trial
Apotex ALENDRONATE SODIUM alendronate sodium TABLET;ORAL 077982-001 Aug 4, 2008 AB RX 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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Expired US Patents for alendronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-002 Sep 29, 1995   Try a Free Trial   Try a Free Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-002 Sep 29, 1995   Try a Free Trial   Try a Free Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-003 Apr 25, 1997   Try a Free Trial   Try a Free Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-004 Oct 20, 2000   Try a Free Trial   Try a Free Trial
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-005 Oct 20, 2000   Try a Free Trial   Try a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Supplementary Protection Certificates for alendronate sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1175904 CA 2007 00045 Denmark   Try a Free Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
1175904 91364 Luxembourg   Try a Free Trial 91364, EXPIRES: 20200826
1175904 C01175904/01 Switzerland   Try a Free Trial FORMER OWNER: SCHERING CORPORATION, US
0998292 CA 2006 00005 Denmark   Try a Free Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
0998292 91222 Luxembourg   Try a Free Trial 91222, EXPIRES: 20200824
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.