NEORAL Drug Patent Profile
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Which patents cover Neoral, and when can generic versions of Neoral launch?
Neoral is a drug marketed by Novartis and is included in two NDAs.
The generic ingredient in NEORAL is cyclosporine. There are eighteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Neoral
A generic version of NEORAL was approved as cyclosporine by HIKMA on October 29th, 1999.
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Summary for NEORAL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 89 |
| Clinical Trials: | 129 |
| Patent Applications: | 4,337 |
| Drug Prices: | Drug price information for NEORAL |
| What excipients (inactive ingredients) are in NEORAL? | NEORAL excipients list |
| DailyMed Link: | NEORAL at DailyMed |
Recent Clinical Trials for NEORAL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fred Hutchinson Cancer Center | Phase 2 |
| National Cord Blood Network | Phase 2 |
| Erasmus Medical Center | N/A |
Pharmacology for NEORAL
| Drug Class | Calcineurin Inhibitor Immunosuppressant |
| Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
US Patents and Regulatory Information for NEORAL
| 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 | CAPSULE;ORAL | 050715-001 | Jul 14, 1995 | AB1 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novartis | NEORAL | cyclosporine | SOLUTION;ORAL | 050716-001 | Jul 14, 1995 | AB1 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novartis | NEORAL | cyclosporine | CAPSULE;ORAL | 050715-003 | Jul 14, 1995 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | NEORAL | cyclosporine | CAPSULE;ORAL | 050715-002 | Jul 14, 1995 | AB1 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 NEORAL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 | SOLUTION;ORAL | 050716-001 | Jul 14, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NEORAL
See the table below for patents covering NEORAL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Czech Republic | 281790 | Farmaceutický přípravek (PHARMACEUTICAL PREPARATION) | ⤷ Sign Up |
| Norway | 20020629 | ⤷ Sign Up | |
| Denmark | 0539319 | ⤷ Sign Up | |
| Hungary | T62201 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NEORAL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2049079 | LUC00006 | Luxembourg | ⤷ Sign Up | 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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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.
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