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Last Updated: July 6, 2020

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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 4th, 2013.

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Drug patent expirations by year for RECLAST
Drug Prices for RECLAST

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Recent Clinical Trials for RECLAST

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SponsorPhase
University of NebraskaPhase 1/Phase 2
University of California, San FranciscoPhase 4
National Institute on Aging (NIA)Phase 4

See all RECLAST clinical trials

Pharmacology for RECLAST
Drug ClassBisphosphonate
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   Start Trial   Start Trial   Start Trial
Novartis RECLAST zoledronic acid INJECTABLE;INTRAVENOUS 021817-001 Apr 16, 2007 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for RECLAST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1591122 132013902140458 Italy   Start Trial PRODUCT NAME: ACIDO ZOLEDRONICO(ACLASTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/05/308/002, 20071003;57363, 20070927
0275821 C300058 Netherlands   Start Trial 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   Start Trial 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   Start Trial PRODUCT NAME: ZOLEDRONSAEURE; REGISTRATION NO/DATE: SWISSMEDIC 57363 27.09.2007
1591122 300582 Netherlands   Start Trial 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   Start Trial PRODUCT NAME: ACIDE ZOLEDRONIQUE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001 20010321; FIRST REGISTRATION: CH 55463 20001128
1591122 122013000031 Germany   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
McKinsey
Express Scripts
Medtronic
Baxter

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