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Last Updated: March 28, 2024

Zoledronic acid - Generic Drug Details


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

Zoledronic acid is the generic ingredient in four branded drugs marketed by Sandoz, Gland Pharma Ltd, Accord Hlthcare, Actavis Inc, Amneal, Apotex, Avet Lifesciences, Bpi Labs, Breckenridge, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma Farmaceutica, Hospira, Hospira Inc, Inforlife, Meitheal, Mylan Labs Ltd, Novast Labs, Sagent Pharms Inc, Shilpa, Sun Pharma Global, USV, and Novartis, and is included in forty NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Zoledronic acid has thirty-nine patent family members in twenty-four 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.

Drug Prices for zoledronic acid

See drug prices for zoledronic acid

Recent Clinical Trials for zoledronic acid

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

SponsorPhase
Sun Yat-sen UniversityPhase 3
AUVA Traumazentrum Vienna Site UKH MeidlingPhase 2
Ludwig Boltzmann Institute for Traumatology _ The research center in cooperation with AUVAPhase 2

See all zoledronic acid clinical trials

Generic filers with tentative approvals for ZOLEDRONIC ACID
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial4MG/5ML(0.8MG/ML)INJECTABLE;INJECTION
⤷  Try a Trial⤷  Try a TrialEQ 4MG BASE/5MLINJECTABLE; IV (INFUSION)
⤷  Try a Trial⤷  Try a TrialEQ 4MG BASE/VIALINJECTABLE; IV (INFUSION)

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for zoledronic acid
Drug ClassBisphosphonate
Paragraph IV (Patent) Challenges for ZOLEDRONIC ACID
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZOMETA Injection zoledronic acid 4 mg/100 mL, 100 mL vial 021223 1 2012-01-31
RECLAST Injection zoledronic acid 0.05 mg/mL, 100 mL vial 021817 1 2008-08-29
ZOMETA Injection zoledronic acid 0.8 mg (base) /mL 021223 1 2008-06-11

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
Mylan Labs Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 202650-001 Mar 4, 2013 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira Inc ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 202837-001 Apr 5, 2013 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Inforlife ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 202828-001 Sep 23, 2013 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 091516-001 Apr 23, 2015 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gland Pharma Ltd ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 209578-001 Aug 8, 2019 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 zoledronic acid

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sandoz RECLAST zoledronic acid INJECTABLE;INTRAVENOUS 021817-001 Apr 16, 2007 ⤷  Try a Trial ⤷  Try a Trial
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-002 Mar 7, 2003 ⤷  Try a Trial ⤷  Try a Trial
Sandoz RECLAST zoledronic acid INJECTABLE;INTRAVENOUS 021817-001 Apr 16, 2007 ⤷  Try a Trial ⤷  Try a Trial
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-002 Mar 7, 2003 ⤷  Try a Trial ⤷  Try a Trial
Novartis ZOMETA zoledronic acid INJECTABLE;INTRAVENOUS 021223-001 Aug 20, 2001 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for zoledronic acid

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for zoledronic acid

Country Patent Number Title Estimated Expiration
Australia 2001261283 ⤷  Try a Trial
Taiwan I345977 ⤷  Try a Trial
New Zealand 545343 Pharmaceutical products comprising bisphosphonates ⤷  Try a Trial
Russian Federation 2358739 ФАРМАЦЕВТИЧЕСКИЕ ПРОДУКТЫ, СОДЕРЖАЩИЕ БИФОСФОНАТЫ (PHARMACEUTICAL PRODUCTS CONTAINING BIPHOSPHONATES) ⤷  Try a Trial
Peru 20050468 PRODUCTOS FARMACEUTICOS QUE COMPRENDEN BISFOSFONATOS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for zoledronic acid

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0275821 01C0035 France ⤷  Try a Trial PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
0275821 SPC/GB01/039 United Kingdom ⤷  Try a Trial 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
1591122 132013902140458 Italy ⤷  Try a Trial PRODUCT NAME: ACIDO ZOLEDRONICO(ACLASTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/05/308/002, 20071003;57363, 20070927
0258618 SPC/GB01/042 United Kingdom ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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