RESTASIS MULTIDOSE Drug Patent Profile
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Which patents cover Restasis Multidose, and when can generic versions of Restasis Multidose launch?
Restasis Multidose is a drug marketed by Abbvie and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-three patent family members in twenty-six countries.
The generic ingredient in RESTASIS MULTIDOSE 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 Restasis Multidose
A generic version of RESTASIS MULTIDOSE was approved as cyclosporine by HIKMA on October 29th, 1999.
Summary for RESTASIS MULTIDOSE
| International Patents: | 63 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 4 |
| Clinical Trials: | 51 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RESTASIS MULTIDOSE |
| What excipients (inactive ingredients) are in RESTASIS MULTIDOSE? | RESTASIS MULTIDOSE excipients list |
| DailyMed Link: | RESTASIS MULTIDOSE at DailyMed |
Recent Clinical Trials for RESTASIS MULTIDOSE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| OphRx Ltd. | Early Phase 1 |
| Boston Sight | Phase 1/Phase 2 |
| Allergan | Phase 1/Phase 2 |
Pharmacology for RESTASIS MULTIDOSE
| Drug Class | Calcineurin Inhibitor Immunosuppressant |
| Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
Paragraph IV (Patent) Challenges for RESTASIS MULTIDOSE
| 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 RESTASIS MULTIDOSE
RESTASIS MULTIDOSE is protected by ten US patents.
Patents protecting RESTASIS MULTIDOSE
Dispensing device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dispensing device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods of providing therapeutic effects using cyclosporin components
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods of providing therapeutic effects using cyclosporin components
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: INCREASE TEAR PRODUCTION TO TREAT PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).
Methods of providing therapeutic effects using cyclosporin components
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods of providing therapeutic effects using cyclosporin components
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: INCREASE TEAR PRODUCTION IN PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).
Methods of providing therapeutic effects using cyclosporin components
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods of providing therapeutic effects using cyclosporin components
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: INCREASE TEAR PRODUCTION TO TREAT PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).
Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 |
International Patents for RESTASIS MULTIDOSE
See the table below for patents covering RESTASIS MULTIDOSE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2003231646 | LACRIMAL GLAND SPECIFIC EMULSION FOR TOPICAL APPLICATION TO OCULAR TISSUE | ⤷ Try a Trial |
| Japan | 5390420 | ⤷ Try a Trial | |
| South Korea | 102231385 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RESTASIS MULTIDOSE
| 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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