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Last Updated: May 25, 2022

RECLAST Drug Patent 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-two suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.

DrugPatentWatch® 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

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

SponsorPhase
Australian and New Zealand Intensive Care Research CentrePhase 2
University of NebraskaPhase 1/Phase 2
San Francisco VA Health Care SystemPhase 4

See all RECLAST clinical trials

Paragraph IV (Patent) Challenges for RECLAST
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RECLAST Injection zoledronic acid 0.05 mg/mL, 100 mL vial 021817 1 2008-08-29

US Patents and Regulatory Information for RECLAST

RECLAST is protected by two US patents.

Patents protecting RECLAST

Pharmaceutical products comprising bisphosphonates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of administering bisphosphonates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT AND PREVENTION OF POSTMENOPAUSAL OR GLUCOCORTICOID-INDUCED OSTEOPOROSIS AND TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS

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

International Patents for RECLAST

See the table below for patents covering RECLAST around the world.

Country Patent Number Title Estimated Expiration
Cyprus 1827 Substituted alkanediphosphonic acids See Plans and Pricing
China 1272013 See Plans and Pricing
South Korea 960010752 See Plans and Pricing
World Intellectual Property Organization (WIPO) 0197788 See Plans and Pricing
Tunisia SN06084 PHARMACEUTICAL PRODUCTS COMPRISING BISPHOSPHONATES See Plans and Pricing
South Africa 8708698 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RECLAST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1591122 2013C/022 Belgium See Plans and Pricing PRODUCT NAME: ACIDE ZOLEDRONIQUE; AUTHORISATION NUMBER AND DATE: C(2007)4619 20071003
0275821 2001C/035 Belgium See Plans and Pricing PRODUCT NAME: ACIDE ZOLEDRONIQUE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001 20010321; FIRST REGISTRATION: CH 55463 20001128
0275821 01C0035 France See Plans and Pricing PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
0258618 SPC/GB01/042 United Kingdom See Plans and Pricing PRODUCT NAME: ZOLEDRONIC ACID 2-(IMIDAZOL-1-YL)-1-HYDROXYETHANE-1,1-DIPHOSPHONIC ACID; REGISTERED: CH 55463 20001128; UK EU/1/01/176/001 20010320; UK EU/1/01/176/002 20010320; UK EU/1/01/176/003 20010320
1591122 300582 Netherlands See Plans and Pricing PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003
0275821 C300058 Netherlands See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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