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RECLAST Drug Profile

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Which patents cover Reclast, and what substitute generic drugs 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-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. Eighteen suppliers are listed for this compound. There are twelve 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
Bulk Api Vendors: see list86
Clinical Trials: see list4
Patent Applications: see list2,770
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:RECLAST at DailyMed

Pharmacology for Tradename: RECLAST

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
RECLAST
zoledronic acid
INJECTABLE;IV (INFUSION)021817-001Apr 16, 2007RXYesYes8,052,987► Subscribe ► Subscribe
Novartis
RECLAST
zoledronic acid
INJECTABLE;IV (INFUSION)021817-001Apr 16, 2007RXYesYes7,932,241*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: RECLAST

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► Subscribe
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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
New Zealand523086► Subscribe
Morocco28078► Subscribe
Cyprus1113740► Subscribe
MexicoPA02012682► Subscribe
China1852739► Subscribe
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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
1591122/01Switzerland► SubscribePRODUCT NAME: ZOLEDRONSAEURE; REGISTRATION NO/DATE: SWISSMEDIC 57363 27.09.2007
2013 00016Denmark► Subscribe
C0035France► SubscribePRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
C/GB01/042United Kingdom► SubscribePRODUCT 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
174Luxembourg► SubscribePRODUCT NAME: ACIDE ZOLEDRONIQUE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE OU TOUT HYDRATE DE CELUI-CI
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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