ZOLEDRONIC Drug Patent Profile
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Which patents cover Zoledronic, and what generic alternatives are available?
Zoledronic is a drug marketed by 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, and USV. and is included in thirty-eight NDAs.
The generic ingredient in ZOLEDRONIC is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zoledronic
A generic version of ZOLEDRONIC was approved as zoledronic acid by DR REDDYS LABS LTD on March 4th, 2013.
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Summary for ZOLEDRONIC
| US Patents: | 0 |
| Applicants: | 26 |
| NDAs: | 38 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 232 |
| Clinical Trials: | 290 |
| Patent Applications: | 71 |
| Drug Prices: | Drug price information for ZOLEDRONIC |
| DailyMed Link: | ZOLEDRONIC at DailyMed |
Recent Clinical Trials for ZOLEDRONIC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Aksaray University | Phase 4 |
| Lund University Hospital | Phase 4 |
| Sun Yat-sen University | Phase 3 |
Pharmacology for ZOLEDRONIC
| Drug Class | Bisphosphonate |
US Patents and Regulatory Information for ZOLEDRONIC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novast Labs | ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 208968-001 | Feb 19, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Meitheal | ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 213371-001 | Jun 5, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sagent Pharms Inc | ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 091493-001 | Nov 24, 2014 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Labs Ltd | ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 202650-001 | Mar 4, 2013 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland Pharma Ltd | ZOLEDRONIC | zoledronic acid | INJECTABLE;INTRAVENOUS | 205749-001 | Jun 29, 2018 | AP | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eugia Pharma | ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 209125-001 | Dec 8, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for ZOLEDRONIC
| 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 |
