You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 18, 2024

ZOMETA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Zometa patents expire, and when can generic versions of Zometa launch?

Zometa is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-nine patent family members in twenty-four countries.

The generic ingredient in ZOMETA 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Zometa

A generic version of ZOMETA was approved as zoledronic acid by DR REDDYS LABS LTD on March 4th, 2013.

  Sign Up

Drug patent expirations by year for ZOMETA
Drug Prices for ZOMETA

See drug prices for ZOMETA

Recent Clinical Trials for ZOMETA

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

SponsorPhase
Assiut UniversityPhase 3
Australian and New Zealand Intensive Care Research CentrePhase 2
Lithuanian University of Health SciencesN/A

See all ZOMETA clinical trials

Paragraph IV (Patent) Challenges for ZOMETA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZOMETA Injection zoledronic acid 4 mg/100 mL, 100 mL vial 021223 1 2012-01-31
ZOMETA Injection zoledronic acid 0.8 mg (base) /mL 021223 1 2008-06-11

US Patents and Regulatory Information for ZOMETA

ZOMETA is protected by one US patents.

Patents protecting ZOMETA

Pharmaceutical products comprising bisphosphonates
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-001 Aug 20, 2001 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-003 Jun 17, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-002 Mar 7, 2003 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-003 Jun 17, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ZOMETA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-002 Mar 7, 2003 ⤷  Sign Up ⤷  Sign Up
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-001 Aug 20, 2001 ⤷  Sign Up ⤷  Sign Up
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-003 Jun 17, 2011 ⤷  Sign Up ⤷  Sign Up
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-002 Mar 7, 2003 ⤷  Sign Up ⤷  Sign Up
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-001 Aug 20, 2001 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ZOMETA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Accord Healthcare S.L.U. Zoledronic Acid Accord zoledronic acid EMEA/H/C/002667
Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Authorised yes no no 2014-01-16
Actavis Group PTC ehf   Zoledronic acid Actavis zoledronic acid EMEA/H/C/002488
Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.Treatment of adult patients with tumour-induced hypercalcaemia.
Authorised yes no no 2012-04-20
Mylan Pharmaceuticals Limited Zoledronic acid Mylan zoledronic acid EMEA/H/C/002482
Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone;treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Authorised yes no no 2012-08-23
Pfizer Europe MA EEIG Zoledronic Acid Hospira zoledronic acid EMEA/H/C/002365
4 mg / 5 ml and 4 mg / 100 ml:Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.Treatment of adult patients with tumour-induced hypercalcaemia (TIH).5 mg / 100 ml:Treatment of osteoporosis:in post-menopausal women;in men;at increased risk of fracture, including those with a recent low-trauma hip fracture.Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy:in post-menopausal women;in men;at increased risk of fracture.Treatment of Paget's disease of the bone in adults.
Authorised yes no no 2012-11-19
Teva B.V. Zoledronic acid Teva zoledronic acid EMEA/H/C/002439
Prevention of skeletal-related events and treatment of tumour-induced hypercalcaemia.
Authorised yes no no 2012-08-16
Sandoz Pharmaceuticals d.d. Aclasta zoledronic acid EMEA/H/C/000595
Treatment of osteoporosis:, , , in post-menopausal women;, in men;, , , at increased risk of fracture, including those with a recent low-trauma hip fracture., , Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture., , Treatment of Paget's disease of the bone.,
Authorised no no no 2005-04-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ZOMETA

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

Country Patent Number Title Estimated Expiration
Norway 874856 ⤷  Sign Up
Taiwan 200522969 Pharmaceutical products comprising bisphosphonates ⤷  Sign Up
New Zealand 222610 5-MEMBERED-HETEROARYL DIPHOSPHONIC ACIDS, PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITIONS ⤷  Sign Up
Ecuador SP066419 PRODUCTOS FARMACÉUTICOS QUE COMPRENDEN BISFOSFONATOS ⤷  Sign Up
Portugal 85457 PROCESSO PARA A PREPARACAO DE NOVOS DERIVADOS DE ACIDOS ALQUILDIFOSFONICOS E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM ⤷  Sign Up
Colombia 5680461 PRODUCTOS FARMACEUTICOS QUE COMPRENDEN BISFOSFONATOS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZOMETA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0258618 26/2001 Austria ⤷  Sign Up PRODUCT NAME: ZOLEDRONSAEURE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: LI 55463 20001128
1591122 132013902140458 Italy ⤷  Sign Up PRODUCT NAME: ACIDO ZOLEDRONICO(ACLASTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/05/308/002, 20071003;57363, 20070927
0275821 C300058 Netherlands ⤷  Sign Up 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
0258618 SPC/GB01/042 United Kingdom ⤷  Sign Up 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
0275821 01C0035 France ⤷  Sign Up PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
0275821 2001C/035 Belgium ⤷  Sign Up PRODUCT NAME: ACIDE ZOLEDRONIQUE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001 20010321; FIRST REGISTRATION: CH 55463 20001128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.