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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 Pharma Global, 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.

Summary for alendronate sodium

International Patents:	102
US Patents:	5
Tradenames:	4
Applicants:	16
NDAs:	18
Drug Master File Entries:	25
Suppliers / Packagers:	26
Bulk Api Vendors:	79
Clinical Trials:	24
Patent Applications:	7,740
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for alendronate sodium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for alendronate sodium
DailyMed Link:	alendronate sodium at DailyMed

Pharmacology for alendronate sodium

Drug Class

Bisphosphonate

Medical Subject Heading (MeSH) Categories for alendronate sodium

Bone Density Conservation Agents

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 (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 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

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 alendronate sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	076584-001	Aug 4, 2008	AB	RX	No	No
Sun Pharma Global	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	090022-004	Sep 10, 2008	AB	RX	No	No
Upsher Smith Labs	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	075871-003	Apr 22, 2009		DISCN	No	No
Sun Pharma Global	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	090022-003	Sep 10, 2008	AB	RX	No	No

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	020560-004	Oct 20, 2000
Merck And Co Inc	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-004	Oct 20, 2000
Merck And Co Inc	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-003	Apr 25, 1997
Merck And Co Inc	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-003	Apr 25, 1997

International Patents for alendronate sodium

Country	Document Number	Estimated Expiration
Spain	2380924
Germany	69837450
Iceland	5315
European Patent Office	1151752

Supplementary Protection Certificates for alendronate sodium

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2006002,C0998292	Lithuania		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
2006002	Lithuania		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
2007 00045	Denmark		PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
364	Luxembourg		91364, EXPIRES: 20200826