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RECLAST Drug Profile

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

Reclast is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-nine patent family members in thirty-six countries.

The generic ingredient in RECLAST is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.

Summary for RECLAST

International Patents:	69
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	92
Clinical Trials:	9
Patent Applications:	2,772
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RECLAST
DailyMed Link:	RECLAST at DailyMed

Pharmacology for RECLAST

Ingredient-type	Diphosphonates
Drug Class	Bisphosphonate

Synonyms for RECLAST

(1-hydroxy-2-(1H-imidazol-1-yl)ethane-1,1-diyl)bis(phosphonic acid)

(1-Hydroxy-2-(1H-imidazol-1-yl)ethane-1,1-diyl)diphosphonic acid

(1-hydroxy-2-(1H-imidazol-1-yl)ethylidene)bisphosphonic acid

(1-HYDROXY-2-IMIDAZOL-1-YL-1-PHOSPHONO-ETHYL)-PHOSPHONIC ACID

(1-hydroxy-2-imidazol-1-yl-1-phosphono-ethyl)phosphonic acid

(1-hydroxy-2-imidazol-1-yl-1-phosphonoethyl)phosphonic acid

(1-hydroxy-2-imidazol-1-yl-phosphonoethyl)phosphonic acid monohydrate

(1-Hydroxy-2-imidazol-1-ylethylidene)diphosphonic acid

[1-hydroxy-(1H-imidazol-1-yl)-phosphonoethyl] phos

[1-hydroxy-2-(1H-imidazol-1-yl)-1-phosphonoethyl]phosphonic acid

[1-HYDROXY-2-(1H-IMIDAZOL-1-YL)-1,1-ETHANEDIYL]BIS(PHOSPHONIC ACID)

[1-HYDROXY-2-(1H-IMIDAZOL-1-YL)-ETHYLIDENE]BISPHOSPHONIC ACID

[1-hydroxy-2-(1H-imidazol-1-yl)ethane-1,1-diyl]bis(phosphonic acid)

[1-Hydroxy-2-(1H-imidazol-1-yl)ethylidene]bisphosphonic acid

072Z938

1-Hydroxy-2-(1-imidazolyl)ethane-1,1-diphosphonic Acid

1-hydroxy-2-(1H-imidazol-1-yl)ethane-1,1-diyldiphosphonic acid

118072-93-8

2-(imidazol-1-yl)-1-hydroxyethane-1,1-diphosphonic acid

2-(imidazol-1-yl)-1-hydroxyethylidene-1,1-bisphosphonic acid

42181-EP2270008A1

42181-EP2292617A1

42181-EP2295426A1

42181-EP2295427A1

42181-EP2308855A1

42181-EP2311808A1

42181-EP2311829A1

4CH-021386

70HZ18PH24

AB0013187

AB01273947_04

AB01273947-01

AB01273947-02

AB01273947-03

AB07564

AC-1092

AC1L2ACJ

AC1Q6RN3

Aclasta

Aclasta (TN)

Aclasta and Reclast

AK-81486

AKOS005145739

AN-5259

Anhydrous Zoledronic Acid

ANW-57498

API0004654

BC206233

BDBM12578

BIDD:GT0292

BIDD:PXR0134

Bio-0112

Bisphosphonate 3

BPH 91

C-17113

C5H10N2O7P2

CAS-118072-93-8

CGP 42'446

CGP 42446

CGP-42'446

CGP-42446

CGP-42446A

CHEBI:46557

CHEMBL924

CS-1829

CTK8A6898

D08689

D0VM2L

DB00399

DSSTox_CID_22668

DSSTox_GSID_42668

DSSTox_RID_80065

DTXSID0042668

EBD33252

FT-0082657

FT-0601384

GP9100

GTPL3177

HE004088

HE299812

HMS2089O09

HS-0091

HY-13777

I06-0710

JMC515594 Compound 55

KB-62427

KS-00000NZ4

KS-1132

LS-181815

MCULE-1604726355

MFCD00867791

MolPort-002-885-874

NCGC00159521-02

NCGC00159521-03

NCGC00159521-04

NCGC00159521-05

Novartis brand of zoledronic acid

NSC-721517

NSC721517

Orazol

PHO012

Phosphonic acid, (1-hydroxy-2-(1H-imidazol-1-yl)ethylidene)bis-

Phosphonic acid, [1-hydroxy-2-(1H-imidazol-1-yl)ethylidene]bis-

Phosphonic acid, P,P'-[1-hydroxy-2-(1H-imidazol-1-yl)ethylidene]bis-

PubChem14894

Q-201946

Reclast (TN)

RP06507

RTA-01011

S00092

s1314

SC-14082

SCHEMBL19054

SR-05000001436

SR-05000001436-1

ST24033505

STL452893

Tox21_111739

UNII-70HZ18PH24

XRASPMIURGNCCH-UHFFFAOYSA-N

Y1607

Z-1463

Z1691545083

ZINC3803652

ZOL

ZOL 446

Zoledronate

ZOLEDRONIC

Zoledronic acid

Zoledronic acid (INN)

Zoledronic Acid (Zoledronate)

Zoledronic acid [USAN:INN:BAN]

Zoledronic acid [USAN:INN]

Zoledronic Acid Anhydrous

Zoledronic Acid, Anhydrous

Zoledronic acid, Zoledronate

Zomera

Zomera (TN)

Zometa

Zometa (Novartis)

Zometa (TN)

Zometa Concentrate

Zometa, Zomera, Aclasta and Reclast, Zoledronic Acid

US Patents and Regulatory Information for RECLAST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	RECLAST	zoledronic acid	INJECTABLE;IV (INFUSION)	021817-001	Apr 16, 2007	AP	RX	Yes	Yes
Novartis	RECLAST	zoledronic acid	INJECTABLE;IV (INFUSION)	021817-001	Apr 16, 2007	AP	RX	Yes	Yes					Y

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Expired US Patents for RECLAST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	RECLAST	zoledronic acid	INJECTABLE;IV (INFUSION)	021817-001	Apr 16, 2007

Paragraph IV (Patent) Challenges for RECLAST

Drugname	Dosage	Strength	RLD	Submissiondate
	Injection	0.05 mg/mL, 100 mL vial		2008-08-29

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International Patents for RECLAST

Country	Document Number	Estimated Expiration
Iceland	8351
New Zealand	523086
Japan	2003535889
Norway	20026117

Supplementary Protection Certificates for RECLAST

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1591122/01	Switzerland		PRODUCT NAME: ZOLEDRONSAEURE; REGISTRATION NO/DATE: SWISSMEDIC 57363 27.09.2007
174	Luxembourg		PRODUCT NAME: ACIDE ZOLEDRONIQUE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE OU TOUT HYDRATE DE CELUI-CI
2013 00016	Denmark
C/GB01/039	United Kingdom		PRODUCT NAME: ZOLEDRONIC ACID OPTIONALLY IN THE FORM OF A SALT THEREOF; NATIONAL REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: CH 55463 20001128