The generic name for Restasis is cyclosporine ophthalmic emulsion [1]. Cyclosporine is a calcineurin inhibitor immunosuppressant that is used to treat dry eye disease [2].
When is the generic version of Restasis expected?
The U.S. Food and Drug Administration (FDA) approved the first generic version of Restasis, cyclosporine ophthalmic emulsion 0.05%, in August 2022 [3]. This approval followed patent litigation, with a court ruling that the patents protecting Restasis were invalid [4].
What are the approved uses for generic cyclosporine eye drops?
Generic cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to inflammatory forms of chronic keratoconjunctivitis (dry eye disease) [1].
How does generic cyclosporine work for dry eye?
Cyclosporine works by reducing inflammation that can impair tear production. It targets T-cells, which are involved in the inflammatory process that contributes to dry eye disease [2].
What are the potential side effects of cyclosporine eye drops?
Common side effects of cyclosporine ophthalmic emulsion include stinging or burning upon instillation, redness, discharge, watering, eye pain, and blurred vision [1].
Where can I find information on drug patents and exclusivity?
Information on drug patents, exclusivity periods, and generic approvals can be found on DrugPatentWatch.com [5]. This resource tracks the patent landscape for pharmaceutical products, including when patents expire and when generic competition is anticipated or has occurred [5].
Who manufactures the generic version of Restasis?
The first generic version of Restasis was approved for manufacturing by Kissei Pharmaceutical Co., Ltd. [3].
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Sources:
1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050720s034,215093s002Lbl.pdf
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3105754/
3. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approvals-and-completeness-cder-reports
4. https://www.reuters.com/legal/litigation/us-court-invalidates-patent-abbvies-restasis-dry-eye-drug-2024-05-16/
5. https://drugpatentwatch.com/