SANDIMMUNE Drug Patent Profile
✉ Email this page to a colleague
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.
Summary for SANDIMMUNE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 89 |
Clinical Trials: | 98 |
Patent Applications: | 4,326 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for SANDIMMUNE |
What excipients (inactive ingredients) are in SANDIMMUNE? | SANDIMMUNE excipients list |
DailyMed Link: | SANDIMMUNE at DailyMed |
Recent Clinical Trials for SANDIMMUNE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Berinstein, Jeffrey | Phase 4 |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Phase 2 |
Vanderbilt University | Phase 3 |
Pharmacology for SANDIMMUNE
Drug Class | Calcineurin Inhibitor Immunosuppressant |
Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
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 |