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Last Updated: March 29, 2024

SANDIMMUNE Drug Patent Profile


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When do Sandimmune patents expire, and what generic alternatives are available?

Sandimmune is a drug marketed by Novartis and is included in three NDAs.

The generic ingredient in SANDIMMUNE 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 Sandimmune

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

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Drug patent expirations by year for SANDIMMUNE
Drug Prices for SANDIMMUNE

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Recent Clinical Trials for SANDIMMUNE

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

SponsorPhase
Berinstein, JeffreyPhase 4
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase 2
Vanderbilt UniversityPhase 3

See all SANDIMMUNE clinical trials

US Patents and Regulatory Information for SANDIMMUNE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis SANDIMMUNE cyclosporine CAPSULE;ORAL 050625-001 Mar 2, 1990 AB2 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis SANDIMMUNE cyclosporine INJECTABLE;INJECTION 050573-001 Nov 14, 1983 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis SANDIMMUNE cyclosporine CAPSULE;ORAL 050625-003 Nov 23, 1992 BX RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis SANDIMMUNE cyclosporine CAPSULE;ORAL 050625-002 Mar 2, 1990 AB2 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis SANDIMMUNE cyclosporine SOLUTION;ORAL 050574-001 Nov 14, 1983 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 SANDIMMUNE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis SANDIMMUNE cyclosporine CAPSULE;ORAL 050625-001 Mar 2, 1990 ⤷  Try a Trial ⤷  Try a Trial
Novartis SANDIMMUNE cyclosporine CAPSULE;ORAL 050625-003 Nov 23, 1992 ⤷  Try a Trial ⤷  Try a Trial
Novartis SANDIMMUNE cyclosporine CAPSULE;ORAL 050625-002 Mar 2, 1990 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SANDIMMUNE

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

Country Patent Number Title Estimated Expiration
Hong Kong 149595 Novel cyclosporin galenic forms ⤷  Try a Trial
United Kingdom 8903804 ⤷  Try a Trial
Belgium 1005236 COMPOSITIONS PHARMACEUTIQUES A BASE DE CYCLOSPORINES. ⤷  Try a Trial
Japan H02255623 NOVEL CYCLOSPORINE DRUG ⤷  Try a Trial
United Kingdom 9003616 ⤷  Try a Trial
Germany 4005190 ⤷  Try a Trial
Switzerland 680650 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SANDIMMUNE

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.