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.
Summary for zoledronic acid
| International Patents: | 39 |
| US Patents: | 3 |
| Tradenames: | 4 |
| Applicants: | 28 |
| NDAs: | 40 |
| Drug Master File Entries: | 25 |
| Finished Product Suppliers / Packagers: | 23 |
| Raw Ingredient (Bulk) Api Vendors: | 128 |
| Clinical Trials: | 288 |
| Patent Applications: | 4,901 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for zoledronic acid |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for zoledronic acid |
| What excipients (inactive ingredients) are in zoledronic acid? | zoledronic acid excipients list |
| DailyMed Link: | zoledronic acid at DailyMed |
Recent Clinical Trials for zoledronic acid
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sun Yat-sen University | Phase 3 |
| CCSRM Clinical Center for Studies in Regenerative Medicine in cooperation with the Ludwig Boltzmann Institute for Traumatology | Phase 2 |
| AUVA Traumazentrum Vienna Site UKH Meidling | Phase 2 |
Generic filers with tentative approvals for ZOLEDRONIC ACID
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | 4MG/5ML(0.8MG/ML) | INJECTABLE;INJECTION |
| ⤷ Try a Trial | ⤷ Try a Trial | EQ 4MG BASE/5ML | INJECTABLE; IV (INFUSION) |
| ⤷ Try a Trial | ⤷ Try a Trial | EQ 4MG BASE/VIAL | INJECTABLE; 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 Class | Bisphosphonate |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Avet Lifesciences | ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 201801-001 | Mar 29, 2013 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | ZOMETA | zoledronic acid | INJECTABLE;INTRAVENOUS | 021223-001 | Aug 20, 2001 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | ZOMETA | zoledronic acid | INJECTABLE;INTRAVENOUS | 021223-003 | Jun 17, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Hospira | ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 090621-001 | Mar 19, 2015 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sagent Pharms Inc | ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 091493-001 | Nov 24, 2014 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sandoz | RECLAST | zoledronic acid | INJECTABLE;INTRAVENOUS | 021817-001 | Apr 16, 2007 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Gland | ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 204217-001 | Aug 18, 2016 | 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 |
|---|---|---|---|---|---|---|---|
| Novartis | ZOMETA | zoledronic acid | INJECTABLE;INTRAVENOUS | 021223-001 | Aug 20, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | ZOMETA | zoledronic acid | INJECTABLE;INTRAVENOUS | 021223-001 | Aug 20, 2001 | ⤷ 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 | 021223-003 | Jun 17, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sandoz | RECLAST | zoledronic acid | INJECTABLE;INTRAVENOUS | 021817-001 | Apr 16, 2007 | ⤷ 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 | |
| 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 | |
| Phoenix Labs Unlimited Company | Zometa | zoledronic acid | EMEA/H/C/000336 Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone;treatment of tumour-induced hypercalcaemia (TIH);prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone;treatment of tumour-induced hypercalcaemia (TIH);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 | no | no | no | 2001-03-20 | |
| >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 |
|---|---|---|---|
| Colombia | 5680461 | PRODUCTOS FARMACEUTICOS QUE COMPRENDEN BISFOSFONATOS | ⤷ Try a Trial |
| Spain | 2409033 | ⤷ Try a Trial | |
| Japan | 2004501104 | ⤷ Try a Trial | |
| Taiwan | 200522969 | Pharmaceutical products comprising bisphosphonates | ⤷ Try a Trial |
| Argentina | 045670 | PRODUCTOS FARMACEUTICOS QUE COMPRENDEN BISFOSFONATOS | ⤷ Try a Trial |
| Peru | 20050468 | PRODUCTOS FARMACEUTICOS QUE COMPRENDEN BISFOSFONATOS | ⤷ Try a Trial |
| South Korea | 101015718 | ⤷ 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 |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 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.
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