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Last Updated: July 26, 2021

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Cyclosporine - Generic Drug Details

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What are the generic sources for cyclosporine and what is the scope of patent protection?

Cyclosporine is the generic ingredient in seven branded drugs marketed by Apotex, Ivax Sub Teva Pharms, Mayne Pharma, Sandoz, Abbvie, Novartis, Allergan, Paddock Labs Llc, West-ward Pharms Int, Sun Pharma Global, Pharm Assoc, and Wockhardt Bio Ag, and is included in twenty NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cyclosporine has seventy-six patent family members in twenty-six countries.

There are eighteen drug master file entries for cyclosporine. Eleven suppliers are listed for this compound.

Drug Prices for cyclosporine

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Recent Clinical Trials for cyclosporine

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

SponsorPhase
National Medical Research Center for Children's Health, Russian FederationPhase 4
MorphoSys AGPhase 2
AllerganPhase 1/Phase 2

See all cyclosporine clinical trials

US Patents and Regulatory Information for cyclosporine

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 SOLUTION;ORAL 050716-001 Jul 14, 1995 AB1 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Allergan RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Abbvie CYCLOSPORINE cyclosporine SOLUTION;ORAL 065025-001 Mar 3, 2000 AB1 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Ivax Sub Teva Pharms CYCLOSPORINE cyclosporine CAPSULE;ORAL 065110-001 Mar 29, 2005 AB1 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis SANDIMMUNE cyclosporine CAPSULE;ORAL 050625-003 Nov 23, 1992 BX RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 cyclosporine

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

Supplementary Protection Certificates for cyclosporine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049079 LUC00006 Luxembourg ⤷  Free Forever 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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Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
AstraZeneca
McKesson
Express Scripts
Mallinckrodt

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.