UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
January 14, 2014 (January 14, 2014)
Date of Report (Date of Earliest Event Reported)
ALLERGAN, INC.
(Exact Name of Registrant as Specified in its Charter)
| Delaware | 1-10269 | 95-1622442 | ||
| (State of Incorporation) | (Commission File Number) | (IRS Employer Identification Number) |
2525 Dupont Drive
Irvine, California 92612
(Address of Principal Executive Offices) (Zip Code)
(714) 246-4500
(Registrant’s Telephone Number, Including Area Code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01. Regulation FD Disclosure.
On January 14, 2014, the United States Patent and Trademark Office (the “USPTO”) issued U.S. patent number 8,629,111 (the “‘111 Patent”), which covers the specific formulation of Allergan, Inc.’s (the “Company”) Restasis® (cyclosporine ophthalmic emulsion) 0.05% product. The Company has submitted the ‘111 Patent for listing in the United States Food and Drug Administration (the “FDA”) publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book. The ‘111 Patent will expire in August 2024.
In addition, on or about January 15, 2014, the Company plans to submit a Citizen Petition to the FDA regarding the FDA’s published draft guidance that proposes certain approaches for demonstrating bioequivalence in abbreviated new drug applications referring to the new drug application related to the Restasis® product.
This report contains “forward-looking statements,” including the statements related to U.S. patent number 8,629,111 and the Citizen Petition. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company’s expectations and projections. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of the action, or inaction, of the USPTO or the FDA, and risks and uncertainties associated with the timing of governmental actions and the protection of the Company’s intellectual property rights. The Company expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risks can be found in press releases issued by the Company, as well as the Company’s public filings with the United States Securities and Exchange Commission, including the discussion under the heading “Risk Factors” in Allergan’s most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. Copies of Allergan’s press releases and additional information about Allergan are available at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ALLERGAN, INC. | ||||
| Date: January 14, 2014 | By: | /s/ Matthew J. Maletta | ||
| Name: | Matthew J. Maletta | |||
| Title: | Vice President, Associate General Counsel and Secretary | |||