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Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Novartis
AstraZeneca
Farmers Insurance
McKesson
Fish and Richardson
Merck
Dow
Baxter

Generated: February 23, 2018

DrugPatentWatch Database Preview

Cyclosporine - Generic Drug Details

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What are the generic drug sources for cyclosporine and what is the scope of cyclosporine freedom to operate?

Cyclosporine
is the generic ingredient in six branded drugs marketed by Apotex, Ivax Sub Teva Pharms, Mayne Pharma, Sandoz, Abbvie, Novartis, Allergan, Luitpold, West-ward Pharms Int, Apotex Inc, and Wockhardt Bio Ag, and is included in eighteen NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cyclosporine has thirty-one patent family members in eleven countries.

There are seventeen drug master file entries for cyclosporine. Fourteen suppliers are listed for this compound.

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
Allergan RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Ivax Sub Teva Pharms CYCLOSPORINE cyclosporine CAPSULE;ORAL 065110-002 Mar 29, 2005 AB1 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Allergan RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis NEORAL cyclosporine SOLUTION;ORAL 050716-001 Jul 14, 1995 AB1 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc CYCLOSPORINE cyclosporine SOLUTION;ORAL 065167-001 Jan 5, 2005 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis SANDIMMUNE cyclosporine CAPSULE;ORAL 050625-001 Mar 2, 1990 AB2 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis SANDIMMUNE cyclosporine INJECTABLE;INJECTION 050573-001 Nov 14, 1983 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Sign Up ➤ Sign Up
Novartis NEORAL cyclosporine SOLUTION;ORAL 050716-001 Jul 14, 1995 ➤ Sign Up ➤ Sign Up
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-003 Jul 14, 1995 ➤ Sign Up ➤ Sign Up
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-003 Jul 14, 1995 ➤ Sign Up ➤ Sign Up
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-001 Jul 14, 1995 ➤ Sign Up ➤ Sign Up
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 ➤ Sign Up ➤ Sign Up
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-001 Jul 14, 1995 ➤ Sign Up ➤ Sign Up
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-001 Jul 14, 1995 ➤ Sign Up ➤ Sign Up
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-003 Jul 14, 1995 ➤ Sign Up ➤ Sign Up
Novartis NEORAL cyclosporine SOLUTION;ORAL 050716-001 Jul 14, 1995 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for cyclosporine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,618,064 Methods of providing therapeutic effects using cyclosporin components ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for cyclosporine

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
McKinsey
McKesson
Dow
Covington
AstraZeneca
Fuji
Federal Trade Commission
Teva

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 verifification 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.

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