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Last Updated: March 29, 2024

RECLAST Drug Patent Profile


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Which patents cover Reclast, and what generic alternatives are available?

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
Drug Prices for RECLAST

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Recent Clinical Trials for RECLAST

Identify potential brand extensions & 505(b)(2) entrants

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: ⤷  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

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
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
Phoenix Labs Unlimited Company Zometa zoledronic acid EMEA/H/C/000336
Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone;treatment of tumour-induced hypercalcaemia (TIH);prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone;treatment of tumour-induced hypercalcaemia (TIH);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 no no no 2001-03-20
>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 2038692 ⤷  Try a Trial
Greece 3003895 ⤷  Try a Trial
South Africa 200210361 Method of administering bishosphonates. ⤷  Try a Trial
Israel 153229 ⤷  Try a Trial
Japan 2744238 ⤷  Try a Trial
Taiwan I289451 ⤷  Try a Trial
Japan 2005247873 METHOD OF ADMINISTERING BISPHOSPHONATES ⤷  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
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
1591122 300582 Netherlands ⤷  Try a Trial PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003
1591122 92174 Luxembourg ⤷  Try a Trial PRODUCT NAME: ACIDE ZOLEDRONIQUE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE OU TOUT HYDRATE DE CELUI-CI
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
1591122 C300582 Netherlands ⤷  Try a Trial PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003
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
1591122 C01591122/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ZOLEDRONSAEURE; REGISTRATION NO/DATE: SWISSMEDIC 57363 27.09.2007
>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.