Appendix 1

• Author: Kenneth Dorsney
• Pages: 551-556

551

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PARAGRAPH IV NOT IC E LETTER

CONFIDENTIAL—NOT TO BE DISCLOSED

OUTSIDE OF ADDRESSEES OR THEIR COUNSEL

[Date]

VIA FEDERAL EXPRESS

BRAND, Inc.

[Mailing Address]

Re: Generic, Inc. ANDA No. 00-001 for GenX; Notice of Certification of

U.S. Patent Nos. 1, 2, 3 and Offer of Confidential Access to Application

Dear President or Counsel:

As required by Sections 505(j)(2)(B)(i) and (ii) of the Federal Food, Drug and

Cosmetic Act (“Act”) (21 U.S.C. § 355(j)(2)(B)(i), (ii)(II)), (ii)), as amended by Title XI

of the Medicare Prescription Drug, Improvement and Modernization Act, Pub. L. No.

108-173, 117 Stat. 2066 (2003), notice is hereby given to Brand, Inc. (“Brand”)

respectively as the holder of approved New Drug Application (“NDA”) No. 00-001 for

BrandX (GenX Tablets) and the record owner of U.S. Patent Nos. 1 (“the ’001 Patent”); 2

(“the ’002 Patent”); 3 (“the ’003 Patent”), (collectively, "the Brand Patents") that the

Food and Drug Administration (“FDA”) has received an amended Abbreviated New

Drug Application (“amended ANDA”) No. 00-001, submitted by Generic, Inc.

(“Generic”) for BrandX 15, 30 and 45 mg Oral Tablets.

In accordance with 21 C.F.R. § 314.95, Generic hereby cites Section

505(j)(2)(B)(ii)(II) of the Act, and pursuant thereto the following information is hereby

provided:

1. Pursuant to 21 U.S.C. § 355(j)(2)(B)(iv)(I) and 21 C.F.R. § 314.95(c)(1),

Generic hereby notifies you that it submitted to the U.S. Food and Drug Administration

(“FDA”), and the FDA has received, an amended ANDA that contains data from

bioavailability or bioequivalence studies for, and which seeks approval to engage in the

commercial manufacture, use, and/or sale of BrandX 15, 30 and 45 mg Oral Tablets.

2. Pursuant to 21 C.F.R. § 314.95(c)(2), Generic’s amended ANDA has been

designated ANDA No. 00-001 by the FDA.

3. Pursuant to 21 C.F.R. 314.95(c)(3), the “established name” of the

proposed drug product is GenX.

4. Pursuant to 21 C.F.R. § 314.95(c)(4), the active ingredient, strength, and

dosage form of the drug product are as follows: BrandX 15, 30 and 45 mg Oral Tablets.

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