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Last Updated: July 20, 2024

RECLAST Drug Patent Profile


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Which patents cover Reclast, 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.

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Drug patent expirations by year for RECLAST
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Recent Clinical Trials for RECLAST

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SponsorPhase
Australian and New Zealand Intensive Care Research CentrePhase 2
University of NebraskaPhase 1/Phase 2
San Francisco VA Health Care SystemPhase 4

See all RECLAST clinical trials

Pharmacology for RECLAST
Drug ClassBisphosphonate
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  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 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

Supplementary Protection Certificates for RECLAST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0275821 SPC/GB01/039 United Kingdom ⤷  Sign Up 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 122013000031 Germany ⤷  Sign Up PRODUCT NAME: ZOLEDRONSAEURE ODER PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON ODER BELIEBIGES HYDRAT DAVON; NAT. REGISTRATION NO/DATE: EU/1/05/308/001-002 20071003; FIRST REGISTRATION: SCHWEIZ 57363 20070927
1591122 C300582 Netherlands ⤷  Sign Up PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003
1591122 2013C/022 Belgium ⤷  Sign Up PRODUCT NAME: ACIDE ZOLEDRONIQUE; AUTHORISATION NUMBER AND DATE: C(2007)4619 20071003
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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