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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Johnson and Johnson
Citi
Healthtrust
Covington
QuintilesIMS
US Department of Justice
Cipla
US Army

Generated: January 17, 2018

DrugPatentWatch Database Preview

RECLAST Drug Profile

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When do Reclast patents expire, and what generic alternatives 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-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-three suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
Summary for RECLAST
Drug patent expirations by year for RECLAST
Pharmacology for RECLAST
Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

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;IV (INFUSION) 021817-001 Apr 16, 2007 AP RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis RECLAST zoledronic acid INJECTABLE;IV (INFUSION) 021817-001 Apr 16, 2007 AP RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for RECLAST
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Injection 0.05 mg/mL, 100 mL vial ➤ Subscribe 8/29/2008

International Patents for RECLAST

Supplementary Protection Certificates for RECLAST

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB01/042 United Kingdom ➤ Subscribe 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
2013000031 Germany ➤ Subscribe 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
1591122/01 Switzerland ➤ Subscribe PRODUCT NAME: ZOLEDRONSAEURE; REGISTRATION NO/DATE: SWISSMEDIC 57363 27.09.2007
2013 00016 Denmark ➤ Subscribe
C/GB01/039 United Kingdom ➤ Subscribe 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
0582 Netherlands ➤ Subscribe PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003
00582 Netherlands ➤ Subscribe PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003
174 Luxembourg ➤ Subscribe PRODUCT NAME: ACIDE ZOLEDRONIQUE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE OU TOUT HYDRATE DE CELUI-CI
C0035 France ➤ Subscribe PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Citi
Teva
Chubb
Cantor Fitzgerald
Fish and Richardson
Chinese Patent Office
Argus Health
Covington

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