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Fish and Richardson
McKesson
Chinese Patent Office
Moodys
Queensland Health
Argus Health
Accenture
Daiichi Sankyo
Julphar

Generated: December 14, 2018

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FOSAMAX Drug Profile

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When do Fosamax patents expire, and what generic alternatives are available?

Fosamax is a drug marketed by Merck and Merck And Co Inc and is included in three NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has ninety-one patent family members in forty countries.

The generic ingredient in FOSAMAX is alendronate sodium; cholecalciferol. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alendronate sodium; cholecalciferol profile page.

Drug patent expirations by year for FOSAMAX
Pharmacology for FOSAMAX
Drug ClassBisphosphonate
Synonyms for FOSAMAX
(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 (mono-hydrochloride salt, trihydrate)
129318-43-0
1yhm
376A361
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-DIYLDIPHOSPHONATE
4-Amino-1-hydroxybutylidene-1,1-bis(phosphonic acid)
4-Amino-1-hydroxybutylidene-1,1-bisphosphonate
4-AMINO-1-HYDROXYBUTYLIDENE-1,1-BISPHOSPHONIC ACID MONOSODIUM SALT
4-amino-1-hydroxybutylidene-bisphosphonic acid
4-Amino-1-hydroxybutylidine-1,1-bisphosphonate
4-amino-1,1-diphosphonobutan-1-ol
4988K7X26P
66376-36-1
68549-EP2270008A1
68549-EP2292617A1
68549-EP2295426A1
68549-EP2295427A1
68549-EP2308855A1
70013-EP2292592A1
70013-EP2295409A1
70013-EP2305640A2
70013-EP2308479A2
A805927
A835441
AB0008472
AB01274863-01
AB10152
ABDP
AC1L1CW3
AC1Q1W16
Acide alendronique
Acide alendronique [INN-French]
Acido alendronico
Acido alendronico [INN-Spanish]
Acidum alendronicum
Acidum alendronicum [INN-Latin]
AHBuBP
AHButBP
AHD
AJ-74282
AK117216
AKOS001015793
AKOS015895071
Alend
alendronate
Alendronate acid
ALENDRONATE SODIUM
Alendronate sodium anhydrous
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
Alendronic acid, Sodium aldendronate
Alendronicacid
Almerol
Aminohydroxybutane Bisphosphonate
AN-32438
AN-38504
ANW-43156
API0001401
API0005892
Arendal
AS-10963
Avalent
AX8002169
BB_SC-02791
BB_SC-2791
BDBM25313
BG0020
BIDD:GT0180
Binosto
bisphosphonate
bisphosphonate, 65
Bonalon
BPH 1
BRD-K75527158-323-01-3
C-15277
C07752
C4H12NNaO7P2
C4H13NO7P2
CAKRAHQRJGUPIG-UHFFFAOYSA-M
CC-00619
CCG-220631
CHEBI:2567
CHEMBL675
CHEMBL870
CTK8B3779
D07119
D09KLR
DB00630
DTXSID5022568
EX-101
Fosamac
Fosamax (TN)
FT-0641064
G-704650
GTH-42
GTH-42J
GTH-42V
GTH-42W
GTPL3141
HMS3604I12
HSCI1_000337
HSDB 7990
Hydrogen (4-amino-1-hydroxy-1-phosphonobutyl)phosphonate (Na+)
I04-9842
I06-0478
Indrol
J-005667
J10298
KS-1028
L-670452
LS-106421
LS-106423
M-1609
MER-103
MFCD00868112
MFCD01861681
MK 217
MK-0217
MK-217
Monosodium (4-Amino-1-hydroxy-1-phosphonobutyl)phosphonate
Monosodium alendronate
NCGC00096054-01
NCGC00096054-03
NCGC00096054-04
NeoBon
OGSPWJRAVKPPFI-UHFFFAOYSA-N
Onclast
Oprea1_422906
OR006545
Osteovan
P,P'-(4-Amino-1-hydroxybutylidene)bis-phosphonic acid monosodium salt
P,P'-(4-Amino-1-hydroxybutylidene)bisphosphonic acid
PHOSPHONATE, (4-AMINO-1-HYDROXY-1-PHOSPHONOBUTYL)-, SODIUM SALT
Phosphonic acid, (4-amino-1-hydroxybutylidene)bis
Phosphonic acid, (4-amino-1-hydroxybutylidene)bis-
Phosphonic acid, (4-amino-1-hydroxybutylidene)bis-, monosodium salt
Q-200607
SBI-0206778.P001
SC-17297
SC-22170
SCHEMBL18898
SCHEMBL328770
sodium (4-amino-1-hydroxy-1-phosphono-butyl)-hydroxy-phosphinate
sodium (4-amino-1-hydroxy-1-phosphonobutyl)-hydroxyphosphinate
sodium (4-azanyl-1-oxidanyl-1-phosphono-butyl)-oxidanyl-phosphinate
SODIUM ALDENDRONATE
Sodium alendronate
sodium alendronate(1-)
sodium hydrogen(4-amino-1-hydroxy-1-phosphonobutyl)phosphonate
SPECTRUM1505166
ST24034598
ST50036159
Steovess
Teiroc
UNII-4988K7X26P
UNII-X1J18R4W8P
VZ20111
X1J18R4W8P
Y-8756
Z56771118
ZINC3801919

US Patents and Regulatory Information for FOSAMAX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck FOSAMAX alendronate sodium SOLUTION;ORAL 021575-001 Sep 17, 2003 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-002 Sep 29, 1995 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-003 Apr 25, 1997 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-005 Oct 20, 2000 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck FOSAMAX alendronate sodium SOLUTION;ORAL 021575-001 Sep 17, 2003 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Merck FOSAMAX alendronate sodium SOLUTION;ORAL 021575-001 Sep 17, 2003 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-004 Oct 20, 2000 DISCN Yes 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

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Expired US Patents for FOSAMAX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-001 Sep 29, 1995 ➤ Sign Up ➤ Sign Up
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-001 Sep 29, 1995 ➤ Sign Up ➤ Sign Up
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-003 Apr 25, 1997 ➤ Sign Up ➤ Sign Up
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-001 Sep 29, 1995 ➤ Sign Up ➤ Sign Up
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-005 Oct 20, 2000 ➤ Sign Up ➤ Sign Up
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-002 Sep 29, 1995 ➤ Sign Up ➤ Sign Up
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-002 Sep 29, 1995 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for FOSAMAX
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 70 mg/2800 IU and 70 mg/5600 IU ➤ Subscribe ➤ Sign Up
➤ Subscribe Oral Solution 70 mg/75 mL ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for FOSAMAX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
222 Luxembourg ➤ Sign Up 91222, EXPIRES: 20200824
2006002,C0998292 Lithuania ➤ Sign Up PRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
1175904/01 Switzerland ➤ Sign Up FORMER OWNER: SCHERING CORPORATION, US
364 Luxembourg ➤ Sign Up 91364, EXPIRES: 20200826
2007007 Lithuania ➤ Sign Up PRODUCT NAME: ACIDUM ALENDRONICUM NATRIUM, COLECALCIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001 2005 08 24 EU/1/05/310/002 2005 08 24 EU/1/05/310/003 2005 08 24 EU/1/05/310/004 2005 08 24 EU/1/05/310/00 20050824
2007 00045 Denmark ➤ Sign Up PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
00292 Netherlands ➤ Sign Up PRODUCT NAME: ALENDRONINE ZUUR, BIJ VOORKEUR MET MONONATRIUMZOUT IN HET BIJZONDER HET MONONATRIUM TRIHYDRAATZOUT, EN COLECALCIFEROL, WAARIN 70MG ALENDRONINEZUUR AANWEZIG IS, GEBASSERD OP HET GEWICHT VAN ALENDRONINE; REGISTRATION NO/DATE: EU/1/05/310/001-005 20050824
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
McKesson
Chinese Patent Office
Moodys
Queensland Health
Argus Health
Accenture
Daiichi Sankyo
Julphar

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