`
`--
`
`ALLERGAN
`
`2525 Dupont Dnve, p 0 Box 19534 lrv1ne, Cal1forn1a, USA 92623-9534 Telephone (714) 246-4500 Webs1te www allergan com
`
`July 30, 2003
`
`U.S. Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Generic Drugs, HFD-610
`Orange Book Staff
`7500 Standish Place
`Metro Park North II
`Rockville, MD 20855-2773
`
`RE: NDA 50-790 (formerly 21-023)
`REST ASIS™ ( cyclosporine ophthalmic emulsion) 0.05%
`
`Dear Orange Book Staff:
`
`Allergan is notifying your office that the current Orange book shows no patent protection
`for Allergan's RESTASIS™ (cyclosporine ophthalmic emulsion) 0.05%. The following
`information is being supplied so that the omission can be corrected.
`
`Trade Name: RESTASIS™
`Active Ingredient: cyclosporine
`Strength: 0.05%
`Dosage Form: Ophthalmic emulsion
`Approval Date: December 23, 2002
`
`The following patents are place for RESTASIS™ (cyclosporine ophthalmic emulsion)
`0.05%:
`
`Expiration Date
`Patent Number Patent Title
`us 4,649,047
`Ophthalmic Treatment by Topical March 19, 2005
`Administration of Cyclosporin
`us 4,839,342 Method of Increasing Tear
`Production by Topical
`Administration of Cyclosporin
`Nonirritating Emulsion for
`Sensitive Tissue
`
`us 5,474,979
`
`August 2, 2009
`
`May 17,2014
`
`FAMY CARE - EXHIBIT 1026-0001
`
`
`
`NDA 50-790
`Orange Book Listing -Patent Information
`Page 2 of2
`
`Our original NDA stated an expiration date of June 13, 2006 for patent number
`4,839,342. Please note the term of this patent has been extended to the date listed in the
`table above. Allergan is requesting that this patent information be included in the Orange
`Book at your earliest opportunity.
`
`The undersigned declares that the above stated United States Patent Numbers 4,649,047;
`4,839,342 and 5,474,979 cover the formulation, composition, and/or method for use of
`cyclosporine A. This product is currently approved under section 505 of the Federal
`Food, Drug and Cosmetic Act.
`
`Should you require additional information, you may contact me by telephone at 714-246-
`4391, by fax at 714-246-4272, orE-mail at bancroft elizabeth@allergan.com.
`
`Sincerely,
`
`~_(}~
`/u, / Elizabeth Bancroft
`V -
`Senior Director
`Regulatory Affairs
`
`FAMY CARE - EXHIBIT 1026-0002
`
`
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