RECLAST Drug Patent Profile
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When do Reclast patents expire, and when can generic versions of Reclast launch?
Reclast is a drug marketed by Sandoz and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has twenty-six patent family members in twenty-two countries.
The generic ingredient in RECLAST 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 Reclast
A generic version of RECLAST was approved as zoledronic acid by DR REDDYS LABS LTD on March 4th, 2013.
Summary for RECLAST
International Patents: | 26 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 128 |
Clinical Trials: | 26 |
Patent Applications: | 2,772 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for RECLAST |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RECLAST |
What excipients (inactive ingredients) are in RECLAST? | RECLAST excipients list |
DailyMed Link: | RECLAST at DailyMed |
Recent Clinical Trials for RECLAST
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Australian and New Zealand Intensive Care Research Centre | Phase 2 |
University of Nebraska | Phase 1/Phase 2 |
San Francisco VA Health Care System | Phase 4 |
Pharmacology for RECLAST
Drug Class | Bisphosphonate |
Anatomical Therapeutic Chemical (ATC) Classes for RECLAST
Paragraph IV (Patent) Challenges for RECLAST
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
RECLAST | Injection | zoledronic acid | 0.05 mg/mL, 100 mL vial | 021817 | 1 | 2008-08-29 |
US Patents and Regulatory Information for RECLAST
RECLAST is protected by one US patents.
Patents protecting RECLAST
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | ||
>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 RECLAST
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 |
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 RECLAST
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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for RECLAST
See the table below for patents covering RECLAST around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2247123 | ⤷ Try a Trial | |
Luxembourg | 90838 | ⤷ Try a Trial | |
Cyprus | 1113740 | ⤷ Try a Trial | |
Canada | 2410201 | ACIDE ZOLEDRONIQUE ET SES SELS UTILISES POUR LE TRAITEMENT DES AFFECTIONS CARACTERISEES PAR UN RENOUVELLEMENT EXAGERE DES CELLULES OSSEUSES (ZOLEDRONIC ACID OR SALTS THEREOF FOR USE IN THE TREATMENT OF CONDITIONS OF ABNORMALLY INCREASED BONE TURNOVER) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RECLAST
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0275821 | 27/2001 | Austria | ⤷ Try a Trial | PRODUCT NAME: ZOLEDRONSAEURE UND DEREN SALZE UND HYDRATE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320; FIRST REGISTRATION: LI 55463.01 20001128 |
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 |
0275821 | 2001C/035 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ACIDE ZOLEDRONIQUE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001 20010321; FIRST REGISTRATION: CH 55463 20001128 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |