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RESTASIS MULTIDOSE Drug Profile
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» See Plans and PricingWhich patents cover Restasis Multidose, and when can generic versions of Restasis Multidose launch?
Restasis Multidose is a drug marketed by Allergan and is included in one NDA. There are ten patents protecting this drug.
This drug has fifty-seven patent family members in twenty-four countries.
The generic ingredient in RESTASIS MULTIDOSE is cyclosporine. There are eighteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.
US ANDA Litigation and Generic Entry Outlook for Restasis Multidose
A generic version of RESTASIS MULTIDOSE was approved as cyclosporine by WEST-WARD PHARMS INT on October 29th, 1999.
Summary for RESTASIS MULTIDOSE
| International Patents: | 57 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Clinical Trials: | 42 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RESTASIS MULTIDOSE |
| DailyMed Link: | RESTASIS MULTIDOSE at DailyMed |
Recent Clinical Trials for RESTASIS MULTIDOSE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Huons Co., Ltd. | Phase 3 |
| Health Science Authority Singapore | Early Phase 1 |
| Singapore National Eye Centre | Early Phase 1 |
Pharmacology for RESTASIS MULTIDOSE
| Drug Class | Calcineurin Inhibitor Immunosuppressant |
| Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
US Patents and Regulatory Information for RESTASIS MULTIDOSE
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Allergan | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Allergan | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Allergan | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Allergan | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Allergan | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for RESTASIS MULTIDOSE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2640995 | Start Trial |
| South Korea | 20160097369 | Start Trial |
| Australia | 2421388 | Start Trial |
| Spain | 2012116 | Start Trial |
| Serbia | 56922 | Start Trial |
| European Patent Office | 0759773 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
