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RESTASIS MULTIDOSE Drug Profile
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When do Restasis Multidose patents expire, and what generic alternatives are available?
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-five patent family members in twenty-three countries.
The generic ingredient in RESTASIS MULTIDOSE is cyclosporine. There are eighteen drug master file entries for this compound. Eleven 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 January 24th, 2020.
Summary for RESTASIS MULTIDOSE
| International Patents: | 55 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Clinical Trials: | 41 |
| 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 |
|---|---|
| Singapore National Eye Centre | Early Phase 1 |
| Health Science Authority Singapore | Early Phase 1 |
| Pavly Moawd | Phase 3 |
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 | ||||
| >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 |
|---|---|---|
| Denmark | 3083432 | Start Trial |
| Singapore | 11201604963Y | Start Trial |
| Canada | 2933069 | Start Trial |
| Japan | 2010168118 | Start Trial |
| Mexico | 2016007852 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
