RESTASIS Drug Patent Profile
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Which patents cover Restasis, and when can generic versions of Restasis launch?
Restasis is a drug marketed by Abbvie and is included in one NDA. There are ten patents protecting this drug.
The generic ingredient in RESTASIS 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
A generic version of RESTASIS 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?
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- What is Average Wholesale Price for RESTASIS?
Summary for RESTASIS
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 122 |
| Clinical Trials: | 51 |
| Patent Applications: | 4,380 |
| Drug Prices: | Drug price information for RESTASIS |
| Drug Sales Revenues: | Drug sales revenues for RESTASIS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RESTASIS |
| What excipients (inactive ingredients) are in RESTASIS? | RESTASIS excipients list |
| DailyMed Link: | RESTASIS at DailyMed |
Recent Clinical Trials for RESTASIS
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
| Drug Class | Calcineurin Inhibitor Immunosuppressant |
| Mechanism of Action | Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors |
US Patents and Regulatory Information for RESTASIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | RESTASIS | cyclosporine | EMULSION;OPHTHALMIC | 050790-001 | Dec 23, 2002 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Abbvie | RESTASIS MULTIDOSE | cyclosporine | EMULSION;OPHTHALMIC | 050790-002 | Oct 27, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 RESTASIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | RESTASIS | cyclosporine | EMULSION;OPHTHALMIC | 050790-001 | Dec 23, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | RESTASIS | cyclosporine | EMULSION;OPHTHALMIC | 050790-001 | Dec 23, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | RESTASIS | cyclosporine | EMULSION;OPHTHALMIC | 050790-001 | Dec 23, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | RESTASIS | cyclosporine | EMULSION;OPHTHALMIC | 050790-001 | Dec 23, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RESTASIS
See the table below for patents covering RESTASIS 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 | ⤷ Sign Up |
| Brazil | 1101071 | ⤷ Sign Up | |
| Austria | 234076 | ⤷ Sign Up | |
| Australia | 2421388 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RESTASIS
| 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 |
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.
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