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 four patents protecting this drug and two Paragraph IV challenges.
This drug has sixty-two 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. Nineteen 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.
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Questions you can ask:
- What is the 5 year forecast for RESTASIS MULTIDOSE?
- What are the global sales for RESTASIS MULTIDOSE?
- What is Average Wholesale Price for RESTASIS MULTIDOSE?
Summary for RESTASIS MULTIDOSE
International Patents: | 62 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 5 |
Clinical Trials: | 51 |
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 | 2020-01-29 |
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 four US patents.
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 | 8,292,129 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | RX | Yes | Yes | 8,561,859 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | RX | Yes | Yes | 9,676,525 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | RX | Yes | Yes | 9,669,974 | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
>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 RESTASIS MULTIDOSE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | 9,248,191 | ⤷ Try for Free |
Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | 8,629,111 | ⤷ Try for Free |
Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | 8,648,048 | ⤷ Try for Free |
Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | 8,642,556 | ⤷ Try for Free |
Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | 8,685,930 | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RESTASIS MULTIDOSE
See the table below for patents covering RESTASIS MULTIDOSE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 112016013690 | TAMPA PROTETORA PARA UM DISPENSADOR, E DISPOSITIVO DE DESCARGA PARA DESCARREGAR LÍQUIDOS FARMACÊUTICOS E/OU COSMÉTICOS | ⤷ Try for Free |
Japan | 5390420 | ⤷ Try for Free | |
Germany | 69522104 | ⤷ Try for Free | |
World Intellectual Property Organization (WIPO) | 8901772 | ⤷ Try for Free | |
Japan | H03503159 | ⤷ Try for Free | |
>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 for Free | 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 |
Market Dynamics and Financial Trajectory for RESTASIS Multidose
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