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RECLAST Drug Profile

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

This drug has sixty-three patent family members in thirty-five countries.

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

Summary for Tradename: RECLAST

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: RECLAST

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Clinical Trials for: RECLAST

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
RECLAST
zoledronic acid
INJECTABLE;IV (INFUSION)021817-001Apr 16, 2007RXYes8,052,987<disabled> <disabled>
Novartis
RECLAST
zoledronic acid
INJECTABLE;IV (INFUSION)021817-001Apr 16, 2007RXYes7,932,241*PED<disabled>Y<disabled>
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Expired Patents for Tradename: RECLAST

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
RECLAST
zoledronic acid
INJECTABLE;IV (INFUSION)021817-001Apr 16, 20074,939,130*PED<disabled>
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Paragraph IV activity for: RECLAST

Drugname Dosage Strength RLD Submissiondate
zoledronic acidInjection0.05 mg/mL, 100 mL vialReclast8/29/2008

International Patent Family for Tradename: RECLAST

Country Document Number Estimated Expiration
Canada2536206<disabled in preview>
Japan2007505861<disabled in preview>
Morocco28078<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: RECLAST

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00582Netherlands<disabled>PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003
1591122/01Switzerland<disabled>PRODUCT NAME: ZOLEDRONSAEURE; REGISTRATION NO/DATE: SWISSMEDIC 57363 27.09.2007
C/GB01/039United Kingdom<disabled>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
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