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RECLAST Drug Profile

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

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-six suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.

US ANDA Litigation and Generic Entry Outlook for Reclast

A generic version of RECLAST was approved as zoledronic acid by BRECKENRIDGE on March 4^th, 2013.

Summary for RECLAST

International Patents:	69
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	101
Clinical Trials:	11
Patent Applications:	2,772
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RECLAST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RECLAST
DailyMed Link:	RECLAST at DailyMed

See drug prices for RECLAST

Recent Clinical Trials for RECLAST

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Nebraska	Phase 1/Phase 2
University of California, San Francisco	Phase 4
National Institute on Aging (NIA)	Phase 4

See all RECLAST clinical trials

Pharmacology for RECLAST

Drug Class

Bisphosphonate

Paragraph IV (Patent) Challenges for RECLAST

Tradename	Dosage	Ingredient	NDA	Submissiondate
RECLAST	INJECTABLE;INTRAVENOUS	zoledronic acid	021817	2008-08-29

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;INTRAVENOUS	021817-001	Apr 16, 2007	AP	RX	Yes	Yes
Novartis	RECLAST	zoledronic acid	INJECTABLE;INTRAVENOUS	021817-001	Apr 16, 2007	AP	RX	Yes	Yes					Y

Expired US Patents for RECLAST

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

International Patents for RECLAST

Country	Patent Number	Estimated Expiration
Taiwan	I345977
Japan	5005188
Spain	2038692
China	1272013
Canada	1338937
Germany	10199052
Hungary	0301164

Supplementary Protection Certificates for RECLAST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1591122	132013902140458	Italy		PRODUCT NAME: ACIDO ZOLEDRONICO(ACLASTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/05/308/002, 20071003;57363, 20070927
0275821	C300058	Netherlands		PRODUCT NAME: ZOLEDRONINEZUUR, DESGEWENST IN DE VORM VAN EEN ZOUT OF SOLVAAT, IN HET BIJZONDER ZOLEDRONINE-ZUUR-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320
1591122	CA 2013 00016	Denmark		PRODUCT NAME: ZOLEDRONSYRE ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER ET VILKARLIGT HYDRAT DERAF; NAT. REG. NO/DATE: EU/1/05/308, C(2007)4619 20071003; FIRST REG. NO/DATE: CH 57363 20070927
1591122	C01591122/01	Switzerland		PRODUCT NAME: ZOLEDRONSAEURE; REGISTRATION NO/DATE: SWISSMEDIC 57363 27.09.2007
1591122	300582	Netherlands		PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003
0275821	2001C/035	Belgium		PRODUCT NAME: ACIDE ZOLEDRONIQUE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001 20010321; FIRST REGISTRATION: CH 55463 20001128
1591122	122013000031	Germany		PRODUCT NAME: ZOLEDRONSAEURE ODER PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON ODER BELIEBIGES HYDRAT DAVON; NAT. REGISTRATION NO/DATE: EU/1/05/308/001-002 20071003; FIRST REGISTRATION: SCHWEIZ 57363 20070927