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` DEPARTMENT OF HEALTH & HUMAN SERVICES
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` Food and Drug Administration
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` Rockville, MD 20857
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`ANDA 090856
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`Lupin Pharmaceuticals Inc.
`U.S. Agent for: Lupin Limited
`Attention: Leslie Sands
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` Director, Regulatory Affairs
`Harborplace Tower
`111 South Calvert Street, 21st Floor
`Baltimore, MD 21202
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`Dear Madam:
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`This is in reference to your abbreviated new drug application (ANDA) dated October 23, 2008,
`submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (the Act), for
`Fenofibrate Tablets, 48 mg and 145 mg.
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`Reference is also made to your amendments dated April 17, and April 29, 2009; January 29, and
`October 7, 2010; and February 21, July 29, August 26, and October 4, 2011. We also
`acknowledge receipt of your correspondence dated January 29, and March 24, 2009; and October
`7, 2011, addressing the patent issues associated with this ANDA.
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`We have completed the review of this ANDA and have concluded that adequate information has
`been presented to demonstrate that the drug is safe and effective for use as recommended in the
`submitted labeling. Accordingly the ANDA is approved, effective on the date of this letter. The
`Division of Bioequivalence has determined your Fenofibrate Tablets, 48 mg and 145 mg, to be
`bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), Tricor
`Tablets, 48 mg and 145 mg, respectively, of Abbott Laboratories (Abbott). Your dissolution
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` testing should be incorporated into the stability and quality control program using the same
`method proposed in your ANDA.
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`The RLD upon which you have based your ANDA, Abbott’s Tricor Tablets, is subject to periods
`of patent protection. The following unexpired patents and their expiration dates are currently
`listed in the agency’s publication titled Approved Drug Products with Therapeutic Equivalence
`Evaluations (the “Orange Book”) for this drug product:
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`6,277,405 (the '405 patent)
`6,375,986 (the '986 patent)
`6,652,881 (the '881 patent)
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`U.S. Patent Number
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`Expiration Date
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`January 9, 2018
`September 21, 2020
`January 9, 2018
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`Reference ID: 3063513
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`January 9, 2018
`7,037,529 (the '529 patent)
`January 9, 2018
`7,041,319 (the '319 patent)
`7,276,249 (the '249 patent) February 21, 2023
`7,320,802 (the '802 patent) February 21, 2023
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`Your ANDA contains paragraph IV certifications under section 505(j)(2)(A)(vii)(IV) of the Act
`stating that each of these seven patents is invalid, unenforceable, or will not be infringed by your
`manufacture, use, or sale of Fenofibrate Tablets, 48 mg and 145 mg, under this ANDA. You
`have notified the agency that Lupin Limited (Lupin) complied with the requirements of section
`505(j)(2)(B) of the Act, and that litigation for infringement of all seven patents was initiated
`against Lupin within the statutory 45-day period in the United States District Court for the
`District of New Jersey [Abbott Laboratories and Laboratories Fournier S.A. v. Lupin Limited
`and Lupin Pharmaceuticals, Inc., Civil Action No. 09-cv-01007-SDW-MCA, for the '405, '529,
`and '319 patents; and Abbott Laboratories and Laboratories Fournier S.A. v. Lupin Limited and
`Lupin Pharmaceuticals, Inc., Civil Action No. 09-cv-01008-SDW-MCA, for the '249 and '802
`patents]. You have also notified the agency that each case was dismissed.
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`Under section 506A of the Act, certain changes in the conditions described in this ANDA require
`an approved supplemental application before the change may be made.
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`Please note that if FDA requires a Risk Evaluation & Mitigation Strategy (REMS) for a listed
`drug, an ANDA citing that listed drug also will be required to have a REMS. See section 505-
`1(i) of the Act.
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`Postmarketing reporting requirements for this ANDA are set forth in 21 CFR 314.80-81 and
`314.98. The Office of Generic Drugs should be advised of any change in the marketing status of
`this drug.
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`Promotional materials may be submitted to FDA for comment prior to publication or
`dissemination. Please note that these submissions are voluntary. If you desire comments on
`proposed launch promotional materials with respect to compliance with applicable regulatory
`requirements, we recommend you submit, in draft or mock-up form, two copies of both the
`promotional materials and package insert directly to:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`5901-B Ammendale Road
`Beltsville, MD 20705
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`We call your attention to 21 CFR 314.81(b)(3) which requires that all promotional materials be
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`submitted to the Office of Prescription Drug Promotion with a completed Form FDA 2253 at the
`time of their initial use.
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`As soon as possible, but no later than 14 days from the date of this letter, submit, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling [21 CFR
`314.50(l)] in structured product labeling (SPL) format, as described at
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`Reference ID: 3063513
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical in content to the approved labeling (including the package insert, and any patient
`package insert and/or Medication Guide that may be required). Information on submitting SPL
`files using eLIST may be found in the guidance for industry titled “SPL Standard for Content of
`Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf. The SPL will be accessible via publicly available labeling repositories.
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`Sincerely yours,
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`{See appended electronic signature page}
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`Keith Webber, Ph.D.
`Deputy Director
`Office of Pharmaceutical Science
`Center for Drug Evaluation and Research
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`Reference ID: 3063513
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`ROBERT L WEST
`12/23/2011
`Deputy Director, Office of Generic Drugs
`for Keith Webber, Ph.D.
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`Reference ID: 3063513
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