ZOLEDRONIC ACID Drug Patent Profile
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Which patents cover Zoledronic Acid, and when can generic versions of Zoledronic Acid launch?
Zoledronic Acid is a drug marketed by 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, Gland Pharma Ltd, 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-seven NDAs.
The generic ingredient in ZOLEDRONIC ACID 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 Zoledronic Acid
A generic version of ZOLEDRONIC ACID was approved as zoledronic acid by DR REDDYS LABS LTD on March 4th, 2013.
Summary for ZOLEDRONIC ACID
| US Patents: | 0 |
| Applicants: | 26 |
| NDAs: | 37 |
| Finished Product Suppliers / Packagers: | 21 |
| Raw Ingredient (Bulk) Api Vendors: | 128 |
| Clinical Trials: | 288 |
| Patent Applications: | 2,772 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
| Ludwig Boltzmann Institute for Traumatology _ The research center in cooperation with AUVA | Phase 2 |
| CCSRM Clinical Center for Studies in Regenerative Medicine in cooperation with the Ludwig Boltzmann Institute for Traumatology | Phase 2 |
Pharmacology for ZOLEDRONIC ACID
| Drug Class | Bisphosphonate |
Anatomical Therapeutic Chemical (ATC) Classes for ZOLEDRONIC ACID
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| 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 | |||
| Shilpa | ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 208513-001 | May 15, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mylan Labs Ltd | ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 203841-001 | Feb 14, 2017 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Accord Hlthcare | ZOLEDRONIC ACID | zoledronic acid | INJECTABLE;INTRAVENOUS | 205279-001 | Nov 28, 2016 | 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 | |||
| >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 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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
