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Generated: August 20, 2019

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FOSAMAX Drug Profile

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Which patents cover Fosamax, and when can generic versions of Fosamax launch?

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-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)diphosphonic acid
(4-azanyl-1-oxidanyl-1-phosphono-butyl)phosphonic acid
121268-17-5 (mono-hydrochloride salt, trihydrate)
1yhm
376A361
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-1,1-diphosphonobutan-1-ol
66376-36-1
68549-EP2270008A1
68549-EP2292617A1
68549-EP2295426A1
68549-EP2295427A1
68549-EP2308855A1
70013-EP2292592A1
70013-EP2295409A1
70013-EP2305640A2
70013-EP2308479A2
A835441
AB0008472
AB01274863-01
ABDP
AC1L1CW3
Acide alendronique
Acide alendronique [INN-French]
Acido alendronico
Acido alendronico [INN-Spanish]
Acidum alendronicum
Acidum alendronicum [INN-Latin]
AHD
AJ-74282
AK117216
AKOS001015793
alendronate
Alendronate acid
ALENDRONATE SODIUM
ALENDRONIC ACID
Alendronic acid (INN)
Alendronic acid [INN:BAN]
AN-38504
ANW-43156
API0005892
Arendal
AS-10963
AX8002169
BDBM25313
BIDD:GT0180
bisphosphonate
bisphosphonate, 65
BPH 1
BRD-K75527158-323-01-3
C-15277
C07752
C4H13NO7P2
CC-00619
CHEBI:2567
CHEMBL870
CTK8B3779
D07119
DB00630
DTXSID5022568
FT-0641064
GTPL3141
HSCI1_000337
HSDB 7990
I04-9842
J10298
LS-106421
M-1609
MK-217
NCGC00096054-01
NCGC00096054-03
NCGC00096054-04
OGSPWJRAVKPPFI-UHFFFAOYSA-N
Oprea1_422906
P,P'-(4-Amino-1-hydroxybutylidene)bisphosphonic acid
Phosphonic acid, (4-amino-1-hydroxybutylidene)bis
Phosphonic acid, (4-amino-1-hydroxybutylidene)bis-
Q-200607
SBI-0206778.P001
SC-17297
SCHEMBL18898
SPECTRUM1505166
SR-05000001906
SR-05000001906-1
ST24034598
ST50036159
UNII-X1J18R4W8P
VZ20111
X1J18R4W8P
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 ➤ 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 ➤ Sign Up
Merck FOSAMAX alendronate sodium SOLUTION;ORAL 021575-001 Sep 17, 2003 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ 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 020560-005 Oct 20, 2000 ➤ 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 020560-001 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 FOSAMAX alendronate sodium SOLUTION;ORAL 021575-001 Sep 17, 2003 ➤ Sign Up ➤ Sign Up
Merck And Co Inc FOSAMAX alendronate sodium TABLET;ORAL 020560-003 Apr 25, 1997 ➤ 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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1175904 2007C/048 Belgium ➤ Sign Up PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
1175904 C01175904/01 Switzerland ➤ Sign Up FORMER OWNER: SCHERING CORPORATION, US
0998292 PA2006002 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 C300292 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
0998292 PA2006002,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 PA2007007 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
1175904 CA 2007 00045 Denmark ➤ Sign Up PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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