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Last Updated: March 28, 2024

NEORAL Drug Patent Profile


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Which patents cover Neoral, and when can generic versions of Neoral launch?

Neoral is a drug marketed by Novartis and is included in two NDAs.

The generic ingredient in NEORAL is cyclosporine. There are eighteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Neoral

A generic version of NEORAL was approved as cyclosporine by HIKMA on October 29th, 1999.

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Drug patent expirations by year for NEORAL
Drug Prices for NEORAL

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Recent Clinical Trials for NEORAL

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

SponsorPhase
ZonMw: The Netherlands Organisation for Health Research and DevelopmentN/A
Erasmus Medical CenterN/A
Brigham and Women's HospitalPhase 2

See all NEORAL clinical trials

US Patents and Regulatory Information for NEORAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-001 Jul 14, 1995 AB1 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis NEORAL cyclosporine SOLUTION;ORAL 050716-001 Jul 14, 1995 AB1 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-003 Jul 14, 1995 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-002 Jul 14, 1995 AB1 RX Yes Yes ⤷  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

Expired US Patents for NEORAL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-003 Jul 14, 1995 ⤷  Try a Trial ⤷  Try a Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-002 Jul 14, 1995 ⤷  Try a Trial ⤷  Try a Trial
Novartis NEORAL cyclosporine SOLUTION;ORAL 050716-001 Jul 14, 1995 ⤷  Try a Trial ⤷  Try a Trial
Novartis NEORAL cyclosporine SOLUTION;ORAL 050716-001 Jul 14, 1995 ⤷  Try a Trial ⤷  Try a Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-003 Jul 14, 1995 ⤷  Try a Trial ⤷  Try a Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-001 Jul 14, 1995 ⤷  Try a Trial ⤷  Try a Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-001 Jul 14, 1995 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NEORAL

See the table below for patents covering NEORAL around the world.

Country Patent Number Title Estimated Expiration
Spain 2227921 ⤷  Try a Trial
South Africa 9204719 ⤷  Try a Trial
Hungary 211685 ⤷  Try a Trial
Norway 943563 ⤷  Try a Trial
Finland 109454 ⤷  Try a Trial
Australia 7423794 ⤷  Try a Trial
European Patent Office 0953630 Produits de transestérification entre l'huile de mais et le glycérol et leur utilisation dans des compositions pharmaceutiques (Transesterification products of corn oil and glycerol and their use in pharmaceutical compositions) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NEORAL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049079 LUC00006 Luxembourg ⤷  Try a Trial PRODUCT NAME: CYCLOSPORINE (GOUTTES OCULAIRES SOUS FORME D'EMULSION); AUTHORISATION NUMBER AND DATE: EU/1/15/990 20150323
>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.