ZOMETA Drug Patent Profile
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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-one 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 BRECKENRIDGE on March 4th, 2013.
Summary for ZOMETA
| International Patents: | 39 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 124 |
| Clinical Trials: | 113 |
| Patent Applications: | 2,772 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ZOMETA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ZOMETA |
| DailyMed Link: | ZOMETA at DailyMed |
Recent Clinical Trials for ZOMETA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assiut University | Phase 3 |
| Australian and New Zealand Intensive Care Research Centre | Phase 2 |
| Lithuanian University of Health Sciences | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for ZOMETA
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: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Novartis | ZOMETA | zoledronic acid | INJECTABLE;INTRAVENOUS | 021223-002 | Mar 7, 2003 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Novartis | ZOMETA | zoledronic acid | INJECTABLE;INTRAVENOUS | 021223-003 | Jun 17, 2011 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 ZOMETA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 |
| Novartis | ZOMETA | zoledronic acid | INJECTABLE;INTRAVENOUS | 021223-003 | Jun 17, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 | |
| >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 |
|---|---|---|---|
| South Korea | 960010752 | ⤷ Try a Trial | |
| Japan | 2012162531 | USE OF ZOLEDRONATE FOR PRODUCING CHEMICALS FOR TREATMENT OF METABOLIC BONE DISEASE | ⤷ Try a Trial |
| European Patent Office | 1286665 | SCHEMA DE TRAITEMENT DU ZOLEDRONATE POUR LES MALADIES DE METABOLISME OSSEUX (TREATMENT REGIMEN OF INTRAVENOUS ZOLEDRONATE FOR THE TREATMENT OF BONE METABOLISM DISEASES) | ⤷ Try a Trial |
| Austria | 72816 | ⤷ Try a Trial | |
| Ireland | 60233 | Diphosphonic acid derivatives, processes for the preparation thereof and pharmaceutical compositions containing them | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZOMETA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0258618 | C300059 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ZOLEDRONINEZUUR, DESGEWENST IN DE VORM VAN EEN FARMACOLOGISCH A ANVAARDBAAR ZOUT OF HYDRAAT OF VAN EEN FARMACOLOGISCH AANVAARDB ARE ESTER MET EEN ALKANOL MET DE FORMULE ROH, WAARIN R C1-C4 AL KYL VOORSTELT, IN HET BIJZONDER ZOLEDRONINEZUUR-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/01/176/001-EU/1/01/176/003 20010320 |
| 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 | 2001C/036 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ACIDE ZOLEDRONIQUE; NATL REGISTRATION NO/DATE: EU/1/01/176/001 20010321; FIRST REGISTRATION: CH 55463 20001128 |
| 0275821 | C300058 | Netherlands | ⤷ Try a Trial | 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 | ⤷ 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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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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