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Serving leading biopharmaceutical companies globally:

Accenture
Farmers Insurance
Daiichi Sankyo
QuintilesIMS
Covington
Cantor Fitzgerald
Moodys
Fuji
Teva
Harvard Business School

Generated: January 21, 2018

DrugPatentWatch Database Preview

Zoledronic acid - Generic Drug Details

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What are the generic drug sources for zoledronic acid and what is the scope of zoledronic acid patent protection?

Zoledronic acid
is the generic ingredient in three branded drugs marketed by Novartis, Accord Hlthcare, Acs Dobfar Info Sa, Actavis Inc, Akorn, Akorn Inc, Apotex Inc, Aurobindo Pharma Ltd, Breckenridge Pharm, Cipla Ltd, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira Inc, Mylan Labs Ltd, Sagent Pharms, Sun Pharma Global, and Usv North America, and is included in thirty-two NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Zoledronic acid has sixty-nine patent family members in thirty-six countries.

There are twenty-five drug master file entries for zoledronic acid. Twenty-three suppliers are listed for this compound. There are eleven tentative approvals for this compound.
Pharmacology for zoledronic acid
Ingredient-typeDiphosphonates
Drug ClassBisphosphonate
Tentative approvals for ZOLEDRONIC ACID
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe4MG/5ML(0.8MG/ML)INJECTABLE;INJECTION
➤ Subscribe➤ SubscribeEQ 4MG BASE/5MLINJECTABLE; IV (INFUSION)
➤ Subscribe➤ SubscribeEQ 4MG BASE/VIALINJECTABLE; IV (INFUSION)

US Patents and Regulatory Information for zoledronic acid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 091516-001 Apr 23, 2015 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sagent Pharms ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 091493-001 Nov 24, 2014 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Breckenridge Pharm ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 202571-001 May 7, 2013 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hikma Farmaceutica ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 202182-001 Jun 3, 2013 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apotex Inc ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 204367-001 Dec 24, 2015 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sun Pharma Global ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 090018-001 Mar 4, 2013 AP RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis RECLAST zoledronic acid INJECTABLE;IV (INFUSION) 021817-001 Apr 16, 2007 AP RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Emcure Pharms Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 201783-001 Mar 12, 2013 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Cipla Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 210174-001 Oct 27, 2017 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gland Pharma Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 202930-001 Aug 5, 2013 AP RX No No ➤ Subscribe ➤ Subscribe ➤ 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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Expired US Patents for zoledronic acid

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-002 Mar 7, 2003 ➤ Subscribe ➤ Subscribe
Novartis RECLAST zoledronic acid INJECTABLE;IV (INFUSION) 021817-001 Apr 16, 2007 ➤ Subscribe ➤ Subscribe
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-002 Mar 7, 2003 ➤ Subscribe ➤ Subscribe
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-001 Aug 20, 2001 ➤ Subscribe ➤ Subscribe
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-001 Aug 20, 2001 ➤ Subscribe ➤ Subscribe
Novartis ZOMETA zoledronic acid INJECTABLE;IV (INFUSION) 021223-003 Jun 17, 2011 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for zoledronic acid

Supplementary Protection Certificates for zoledronic acid

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
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
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
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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
UBS
Johnson and Johnson
Cipla
Farmers Insurance
Cerilliant
Cantor Fitzgerald
AstraZeneca
Accenture

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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