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Last Updated: December 2, 2022

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 eight branded drugs marketed by Apotex, Ivax Sub Teva Pharms, Mayne Pharma, Sandoz, Strides Pharma, Abbvie, Novartis, Mylan, Allergan, Santen, Hikma, Padagis Us, Sun Pharm, Pharm Assoc, and Wockhardt Bio Ag, and is included in twenty-three NDAs. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cyclosporine has one hundred and ninety-nine patent family members in thirty countries.

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

Drug Prices for cyclosporine

See drug prices for cyclosporine

Recent Clinical Trials for cyclosporine

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

SponsorPhase
Center for International Blood and Marrow Transplant ResearchPhase 3
North American Pediatric Aplastic Anemia ConsortiumPhase 3
National Institutes of Health (NIH)Phase 3

See all cyclosporine clinical trials

Paragraph IV (Patent) Challenges for CYCLOSPORINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RESTASIS MULTIDOSE Ophthalmic Emulsion cyclosporine 0.05% 050790 1 2014-01-13

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
Sandoz CYCLOSPORINE cyclosporine CAPSULE;ORAL 065017-001 Jan 13, 2000 AB1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Strides Pharma CYCLOSPORINE cyclosporine CAPSULE;ORAL 216046-003 Aug 2, 2022 AB1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Wockhardt Bio Ag CYCLOSPORINE cyclosporine SOLUTION;ORAL 065133-001 Sep 17, 2004 AB2 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Novartis NEORAL cyclosporine SOLUTION;ORAL 050716-001 Jul 14, 1995 See Plans and Pricing See Plans and Pricing
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for cyclosporine

Country Patent Number Title Estimated Expiration
Australia 2017227585 Topical cyclosporine-containing formulations and uses thereof See Plans and Pricing
Portugal 2404593 See Plans and Pricing
China 105813949 分配器的保护盖和排放药液和/或美容液体的排放装置 (Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cyclosporine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1809237 C300741 Netherlands See Plans and Pricing PRODUCT NAME: CICLOSPORINE (EYE DROP; REGISTRATION NO/DATE: EU/1/15/990 20150319
1809237 C01809237/01 Switzerland See Plans and Pricing PRODUCT NAME: CICLOSPORIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66093 08.09.2016
2049079 PA2017003,C2049079 Lithuania See Plans and Pricing PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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.