APPROVED DRUG PRODUCTS
with
THERAPEUTIC EQUIVALENCE EVALUATIONS
24th EDITION
Cumulative Supplement9

Prepared By
Office of Pharmaceutical Science
Office of Generic Drugs
Center for Drug Evaluation and Research, FDA

September 2004

CONTENTS

1.0 INTRODUCTION

1.1  How to Use the Cumulative Supplement
1.2  Applicant Name Changes
1.3  Ribavirin 200mg Oral Capsule
1.4  Levothyroxine Sodium
1.5  Availability of the Edition
1.6  Report of Counts for the Prescription Drug Product List
1.7  Cumulative Supplement Legend

DRUG PRODUCT LISTS

Prescription Drug Product List  
OTC Drug Product List  
Drug Products with Approval under Section 505 of the Act Administered by the Center for Biologics
 Evaluation and Research List
Orphan Drug Product Designations  
Drug Products Which Must Demonstrate in vivo Bioavailability Only if Product Fails to Achieve Adequate  Dissolution

PATENT AND EXCLUSIVITY INFORMATION ADDENDUM

A. Patent and Exclusivity Lists   

B. Patent and Exclusivity Terms

1.0 INTRODUCTION

1.1 HOW TO USE THE CUMULATIVE SUPPLEMENT

This Cumulative Supplement is one of a series of monthly updates to the Approved Drug Products with Therapeutic Equivalence Evaluations, 24th Edition (the List). The List is composed of four parts: approved prescription drug products with therapeutic equivalence evaluations, over-the-counter (OTC) drug products that require approved applications as a condition of marketing, drug products with approval under Section 505 of the Act administered by the Center for Biologics Evaluation and Research and products that have never been marketed, are for exportation, have been discontinued from marketing or that have had their approvals withdrawn for other than safety or efficacy reasons.

The Cumulative Supplement provides, among other things, information on newly approved drugs and, if necessary, revised therapeutic equivalence evaluations and updated patent and exclusivity data. The Addendum contains appropriate drug patent and exclusivity information required of the Agency by the "Drug Price Competition and Patent Term Restoration Act of 1984" for the Prescription, OTC, and Drug Products with Approval under Section 505 of the Act Administered by the Center for Biologics Evaluation and Research Lists.

The Patent and Exclusivity Lists are arranged in alphabetical order by active ingredient name. For those products with multiple active ingredients, only the first active ingredient (in alphabetical sort) will appear. In addition, the trade name will be displayed to the right of the active ingredient name for each product. Also shown is the application number and product number (FDA's internal file number) for reference purposes. All patents with their expiration dates are displayed for each application number. Use patents are indicated with the symbol "U" followed by a number representing a specific use. Exclusivity information for a specific drug is indicated by an abbreviation followed by the date upon which the exclusivity expires. Refer to the Exclusivity Terms section in the Patent and Exclusivity Information Addendum for an explanation of all codes and abbreviations.

Because all parts of the publication are subject to changes, additions, or deletions, the List must be used in conjunction with the most current Cumulative Supplement. Users may wish to mark to the left of the ingredient(s) in the List to indicate that changes to that entry appear in the Cumulative Supplement.  Drug product information is provided in each Cumulative Supplement for completeness to assist in locating the proper place in the List for the revision.

The presence of any therapeutic equivalence code indicates that the drug product is multisource; the deletion of a therapeutic equivalence code indicates that the drug product has become single source. (An infrequent exception exists when a therapeutic equivalence code is revised. In that case the deletion of the therapeutic equivalence code is followed immediately by the addition of the revised one.)

New additions to the Prescription Drug Product List, OTC Drug Product List, and the Patent and Exclusivity Data are indicated by the symbol >ADD> to the left of the line on which new information exists. The >ADD> symbol is then dropped in subsequent Cumulative Supplements for that item.

New deletions to the Prescription Drug Product List and OTC Drug Product List are indicated by the symbol >DLT> (DELETE) to the left of the line. The >DLT> symbol is dropped in subsequent Cumulative Supplements for that item. The shaded print remains in the Prescription Drug Product List and OTC Drug Product Lists in all Cumulative Supplements (hard copy only) for this edition.

Products that have never been marketed, are for exportation, have been discontinued from marketing or that have had their approvals withdrawn for other than safety or efficacy reasons, will be flagged in this Cumulative Supplement with the "@" symbol to designate their non-marketed status. All products having a "@" symbol in the 12th Cumulative Supplement of the 23rd  Edition List will then be added to the "Discontinued Drug Product List" appearing in the 24th Edition.

1.2 APPLICANT NAME CHANGES

It is not practical to identify in the Cumulative Supplement each and every product involved when an applicant transfers its entire line of approved drug products to another applicant, or when an applicant changes its name. Therefore, the cumulation of these transfers and name changes will be identified in this section only. Where only partial lines of approved products are transferred between applicants, each approved product involved will appear as an applicant name change entry in the Cumulative Supplement.

It is also not practical to identify each and every product involved when an applicant name is changed to meet internal publication standards (e.g., MSD or Zenith [Former Abbreviated Names] are changed, respectively, to Merck Sharp Dohme or Zenith Labs [New Abbreviated Names]). When this occurs, each product involved (either currently in the Cumulative Supplement or in the following year's edition) will automatically reflect the new abbreviated name. Consequently, it will not appear as an applicant name change entry in the Cumulative Supplement nor will the cumulation of these name changes appear in this section. However, when the applicant name change is one which may not be easily recognized or located in the listing (e.g., White Towne Paulsen [Former Abbreviated Name] is changed to Whiteworth Towne [New Abbreviated Name], the name change will appear in this section and will be identified with an asterisk.

APPLICANT NAME CHANGES
 

BERLEX

   (BERLEX) 

BERLEX INC

   (BERLEX INC)

BERLEX LABORATORIES INC

    (BERLEX LABS)

BERLEX INC

    (BERLEX INC)

BERLEX LABORATORIES INC SUB SCHERING AG

   (BERLEX)

BERLEX INC

     (BERLEX INC) 

1.3  RIBAVIRIN 200MG ORAL CAPSULE

The footnote for Ribabvirin 200MG capsule product 001 was inadvertently omitted from the 24th Edition.  The footnote: Indicated for use and comarketed with interferon alfa-2b, recombinant (Intron A), as Rebetron Combination Therapy.

1.4 LEVOTHYROXINE SODIUM

Because there are multiple reference listed drugs of levothyroxine sodium tablets and some reference listed drugs' sponsors have conducted studies to establish their drugs' therapeutic equivalence to other reference listed drugs, FDA has determined that its usual practice of assigning two or three character TE codes may be potentially confusing and inadequate for these drug products. Accordingly, FDA provides the following explanation and chart of therapeutic equivalence evaluations for levothyroxine sodium drug products.

Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be therapeutically equivalent to corresponding strengths of Unithroid (Jerome Stevens NDA 021210) tablets.

Levo-T (Alara NDA 021342) and Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be therapeutically equivalent to corresponding strengths of Synthroid (Abbott NDA 021402) tablets.

Levo-T (Alara NDA 021342), Unithroid (Jerome Stevens NDA 021210) and Levothyroxine Sodium (Mylan ANDA 076187) tablets have been determined to be therapeutically equivalent to corresponding strengths of Levoxyl (King/Jones Pharma NDA 021301) tablets.

Novothyrox (Genpharm NDA 021292) requires further investigation and review to establish therapeutic equivalence to corresponding strengths of any other levothyroxine sodium drug products and is rated BX.

Thyro-Tabs (Lloyd NDA 021116) requires further investigation and review to establish therapeutic equivalence to corresponding strengths of any other levothyroxine sodium drug products and is rated BX.

Levolet (Vintage NDA 021137) requires further investigation and review to establish therapeutic equivalence to corresponding strengths of any other levothyroxine sodium drug products and is rated BX.

The chart outlines TE codes for all 0.025mg products with other products being similar. Therapeutic equivalence has been established between products that have the same AB+number TE code. More than one TE code may apply to some products. One common TE code indicates therapeutic equivalence between products.

 

1.5 AVAILABILITY OF THE EDITION

The 24th Edition of the Orange Book and its monthly cumulative supplements are available by subscription from  the Government Printing Office:

                                                                                        Superintendent of Documents
                                                                                        Government Printing Office
                                                                                        P.O. Box 371954
                                                                                        Pittsburgh, PA 15250-7954
 

The telephone number to charge your subscription is 202-512-1800 or toll free 866-512-1800. The cost is $110.00 annually.
 

The Approved Drug Products with Therapeutic Equivalence Evaluation (Orange Book) and related drug information is also available on the Internet at the Food and Drug Administration, Center for Drug Evaluation and Research, Drug Info page.
 

There is an Electronic Orange Book Query (EOB) at http://www.fda.gov/cder/ob. The Query provides searching of the approved drug list by active ingredient, proprietary name, applicant holder or applicant number. Product search categories are: prescription, over-the-counter, discontinued drugs. There are links to patent and exclusivity information that may be applicable to each product. The data is updated concurrently with the publication of the monthly cumulative supplements.
 

The Internet version of the Orange Book annual edition is at
http://www.fda.gov/cder/orange/adp.htm
 

The Internet version of the monthly supplement is at
http://www.fda.gov/cder/orange/supplement/cspreface.htm.
 

There are ASCII text files of the Orange Book drug product data at http://www.fda.gov/cder/orange/obreadme.htm.  The drug product text files are zipped into EOBZIP.EXE,  a self-extracting zip file.. The files are updated concurrently with the publication of the monthly cumulative supplements. Appendix A and Appendix B are updated quarterly.
 

The 24th annual edition of the 2002 Orange Book Patent and Exclusivity List is at
http://www.fda.gov/cder/orange/23bookpub.pdf

The Patent Term Extension and new Patents,  Docket Number *95S-0117, is at http://www.fda.gov/cder/orange/docket.pdf.   It is updated approximately weekly.

The current year Patent and Exclusivity cumulative supplement list that denotes the current month additions is at http://www.fda.gov/cder/orange/supplement/patents.pdf

(The Drug Price Competition and Patent Term Restoration Act requires that patent information be filed with all newly submitted Section 505 drug applications.  Effective August 18, 2003, patent submissions for publication in the Orange Book and Docket *95S-0117 need to be submitted on form FDA-3542 which may be downloaded from PSC Forms Download Website.)

The current listing of the Orphan Product Designations and Approvals is available at http://www.fda.gov/Orphan/designat/list.htm
 

 

1.6 REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST

DESCRIPTION OF REPORT

This report provides summary counts derived from the product information in the Prescription Drug Product List and the current Cumulative Supplement. Products included in the counts are domestically marketed drug products approved for both safety and effectiveness under section 505 of the Federal Food, Drug, and Cosmetic Act. Excluded are approved drug products marketed by distributors; those marketed solely abroad; and those now regarded as medical devices, biologics or foods.

The baseline column (Dec 2003) refers to the products in the Prescription Drug Product List. For each three-month period, a column of quarterly data is added which incorporates counts of product activity from the previous quarter(s) with those in the baseline count.

 

DEFINITIONS

Drug Product

For this report, a drug product is the representation in the Prescription Drug Product List of an active moiety (molecular entity and its salts, esters and derivatives) either as a single ingredient or as a combination product provided in a specific dosage form and strength for a given route of administration with approval for marketing by a firm under a particular generic or trade name.

New Molecular Entity

A new molecular entity is considered an active moiety that has not previously been approved (either as the parent compound or as a salt, ester or derivative of the parent compound) in the United States for use in a drug product either as a single ingredient or as part of a combination.

REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST COUNTS CUMULATIVE BY QUARTER

¹Amino acid-containing products of varying composition (see Introduction, page xx of the List).

1.7  CUMULATIVE SUPPLEMENT LEGEND

The List is sorted by Ingredient(s) and, within each grouping, by the Dosage Form;Route and then by trade name.

The individual product record contains the Therapeutic Equivalence Code, Reference Listed Drug symbol, applicant holder, strength(s), New Drug Approval number, product number, and approval date. The last two columns describe the action. The Action Month is the CS month the action occurred. The OB Action is the type of change that has occurred.

New ingredient(s), new dosage form;route(s), new trade names, and new product additions are preceded by >A> during the action month. The change month is the current CS month; the change code for new approvals is NEWA. Following months will display the same information without the >A>.

Changes to currently listed products will list two records. The deleted product record will be proceeded by >D>. The product record change addition being made will be preceded by >A>. Following months will display only the >A> record without the >A>. All changes that occur to the product through the Annual year will be listed. The change month and change code will document the change.

The change code and description:

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST CUMULATIVE SUPPLEMENT

NO SEPTEMBER 2004 APPROVALS

DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION

NO SEPTEMBER 2004 ADDITIONS

PATENT AND EXCLUSIVITY TERMS

Please refer to this page for an explanation of the patent and exclusivity abbreviations found in the Orange Book.

• Patent Use Codes
• Exclusivity Codes

Back to Top     Orange Book

Date created: February 17, 2004; Updated October 22,, 2004

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