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 nine branded drugs marketed by Apotex, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Sandoz, Strides Pharma, Abbvie, Novartis, Deva Holding As, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Harrow Eye, Hikma, Padagis Us, Sun Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in twenty-eight NDAs. There are twenty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Cyclosporine has three hundred and ten patent family members in thirty-four countries.
There are eighteen drug master file entries for cyclosporine. Nineteen suppliers are listed for this compound.
Summary for cyclosporine
International Patents: | 310 |
US Patents: | 27 |
Tradenames: | 9 |
Applicants: | 17 |
NDAs: | 28 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 19 |
Raw Ingredient (Bulk) Api Vendors: | 89 |
Clinical Trials: | 1,059 |
Patent Applications: | 7,398 |
Drug Prices: | Drug price trends for cyclosporine |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for cyclosporine |
What excipients (inactive ingredients) are in cyclosporine? | cyclosporine excipients list |
DailyMed Link: | cyclosporine at DailyMed |
Recent Clinical Trials for cyclosporine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Fred Hutchinson Cancer Center | Phase 2 |
National Cord Blood Network | Phase 2 |
Assiut University | Phase 1 |
Pharmacology for cyclosporine
Drug Class | Calcineurin Inhibitor Immunosuppressant |
Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Medical Subject Heading (MeSH) Categories for cyclosporine
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | RX | Yes | Yes | ⤷ Free Trial | ⤷ Free Trial | Y | ⤷ Free Trial | |||
Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | RX | Yes | Yes | ⤷ Free Trial | ⤷ Free Trial | Y | ⤷ Free Trial | |||
Harrow Eye | VEVYE | cyclosporine | SOLUTION;OPHTHALMIC | 217469-001 | May 30, 2023 | RX | Yes | Yes | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free Trial | ||||
Harrow Eye | VEVYE | cyclosporine | SOLUTION;OPHTHALMIC | 217469-001 | May 30, 2023 | RX | Yes | Yes | ⤷ Free Trial | ⤷ Free Trial | Y | ⤷ Free 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 |
---|---|---|---|---|---|---|---|
Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | ⤷ Free Trial | ⤷ Free Trial |
Novartis | NEORAL | cyclosporine | SOLUTION;ORAL | 050716-001 | Jul 14, 1995 | ⤷ Free Trial | ⤷ Free Trial |
Novartis | NEORAL | cyclosporine | SOLUTION;ORAL | 050716-001 | Jul 14, 1995 | ⤷ Free Trial | ⤷ Free Trial |
Novartis | NEORAL | cyclosporine | SOLUTION;ORAL | 050716-001 | Jul 14, 1995 | ⤷ Free Trial | ⤷ Free Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for cyclosporine
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2019529457 | ⤷ Free Trial | |
Japan | 6483131 | ⤷ Free Trial | |
Hong Kong | 1107938 | OPHTHALMIC OIL-IN-WATER TYPE EMULSION WITH STABLE POSITIVE ZETA POTENTIAL | ⤷ Free Trial |
World Intellectual Property Organization (WIPO) | 2005032577 | ⤷ Free Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for cyclosporine
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1809237 | CR 2015 00030 | Denmark | ⤷ Free Trial | PRODUCT NAME: CYCLOSPORIN; REG. NO/DATE: EU/1/15/990/001-002 20150323 |
1809237 | CA 2015 00030 | Denmark | ⤷ Free Trial | PRODUCT NAME: CYCLOSPORINOEJENDRABEEMULSION; REG. NO/DATE: EU/1/15/990/001-002 20150319 |
2049079 | PA2017003,C2049079 | Lithuania | ⤷ Free Trial | PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319 |
2049079 | PA2017003 | Lithuania | ⤷ Free Trial | PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Cyclosporine Market Dynamics and Financial Trajectory
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