FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Drug Evaluation and Research
  HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER

horizonal rule
CDER Home About CDER Drug Information Regulatory Guidance CDER Calendar Specific Audiences CDER Achives
Office of Generic Drugs

The Office of Generic Drugs Mailing Address

What are Generic Drugs?

A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.  Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies.  Even more billions are saved when hospitals use generics.

Drug companies must submit an abbreviated new drug application (ANDA) for approval to market a generic product.  The Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, made ANDAs possible by creating a compromise in the drug industry. Generic drug companies gained greater access to the market for prescription drugs, and innovator companies gained restoration of patent life of their products lost during FDA's approval process.

New drugs, like other new products, are developed under patent protection.  The patent protects the investment in the drug's development by giving the company the sole right to sell the drug while the patent is in effect.  When patents or other periods of exclusivity expire, manufacturers can apply to the FDA to sell generic versions.  The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness.  This applies to drugs first marketed after 1962.

Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:

  • contain the same active ingredients as the innovator drug(inactive ingredients may vary)
  • be identical in strength, dosage form, and route of administration
  • have the same use indications
  • be bioequivalent
  • meet the same batch requirements for identity, strength, purity, and quality
  • be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products

For more information on the safety and effectiveness of generic drugs, please see:

Is a Generic Drug Available for a Brand Name Drug?

You can search for generic equivalents by using the "Electronic Orange Book" and search by proprietary "brand" name," then search again by using the active ingredient name. If other manufacturers are listed besides the "brand name" manufacturer when searching by the "active ingredient," they are the generic product manufacturers.

Since there is a lag time after generic products are approved and they appear in the "Orange Book," you should also consult the most recent monthly approvals for "First Generics".

Back to Top

News and Announcements

Recent Court Decisions

  • No recent court decisions

Recent Federal Register Notices

  • Food and Drug Administration [Docket No. 2005N-0331] Able Laboratories, Inc.; Withdrawal of Approval of Ten Abbreviated New Drug Applications [TXT] [PDF] (8/29/2005)

    Summary: The Food and Drug Administration (FDA) is withdrawing approval of ten abbreviated new drug applications (ANDAs) held by Able Laboratories, Inc. (Able Labs), One Able Dr., Cranbury, NJ 08512. Able Labs has initiated a class II recall of the products covered by these ANDAs. The company has requested that the applications be withdrawn and has waived its opportunity for a hearing.

  • Food and Drug Administration [Docket No. 2005D-0312] Draft Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability [TXT] [PDF] (8/29/2005)
    • The Draft Guidance [PDF]

Summary: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ''ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information.'' This draft guidance provides recommendations on what chemistry, manufacturing, and controls information sponsors should include regarding reporting, identification, qualification, and setting acceptance criteria for impurities that are classified as degradation products in drug products when submitting an abbreviated new drug application (ANDA) or supplement to support changes in drug substance synthesis or process, formulation of the drug product, the manufacturing process, or components of the container/closure system.

Back to Top

Generic Drug Approvals

List of Authorized Generic Drugs

  • The quarterly List of Authorized Generic Drugs includes the drug trade name, the brand company manufacturer, and the date the authorized generic drug entered the market.

Back to Top

Requesting an Electronic Common Technical Document (eCTD) Number

  • Step-by-step description of how to request an eCTD number from OGD.
  • You may request a pre-assigned number, ONLY when you are submitting a NEW eCTD ANDA. If you are converting an established ANDA to eCTD, you MUST use the original ANDA application number.
  • If submitting a paper ANDA, do NOT request a pre-assigned number.
  • If you have any comments or questions, please contact:
    Wendy Aaronson
  • wendy.aaronson@fda.hhs.gov

Therapeutic Equivalence of Generic Drugs

  • (8/9/2005) Therapeutic Equivalence between Levothyroxine Sodium drug products.  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. See Annual Edition . Select Bookmark 1.8 Description of Special Situations for a complete explanation of the therapeutic equivalencies and chart.

  • Therapeutic Equivalence of Generic Drugs Letter to Health Practitioners (2/4/1998) This letter addresses therapeutic equivalence between generic and innovator drug products.
  • Therapeutic Equivalence of Generic Drugs Response to National Association of Boards of Pharmacy (2/6/1998) This letter provides background information, and answers to questions on narrow therapeutic drugs and their substitutability.
  • Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) The Orange Book lists approved drug products that are bioequivalent, including new drugs, generic drugs, and antibiotics. Approved nonprescription products are also in the Orange Book along with information about patents and periods of marketing exclusivity.

Back to Top

Generic Drug Development, Abbreviated New Drug Application (ANDA) Submissions, and Review Information

  • Model Bioequivalence Data Summary Tables. [PDF] [Word]  The Division of Bioequivalence has developed new data summary tables so that data can be submitted to the Office of Generic Drugs in a concise format consistent with the Common Technical Document. ANDA applicants should complete these tables and send the completed tables along with the rest of the Bioequivalence submission of their ANDA. There are instructions with the tables explaining how to fill them out. Common Technical Document (CTD) Modules/Sections Corresponding to Summary Data Tables in Bioequivalence Submissions to ANDAs updated

  • ANDA Checklist for Completeness and Acceptability [PDF] [Word] Note: In Sections 3.2.S.2.1 and 3.2.P.3.1, it is critically important that the correct Name, Full Address and establishment contact information of the manufacturing or testing facility location be included (not the corporate address). Additionally, the correct FDA Establishment Identifier number (FEI) or Central File Number (CFN) for the exact facility must be included. updated

  • Inactive Ingredient Database The newly revised Inactive Ingredients Database provides information on inactive ingredients present in FDA-approved drug products. This information can be used by industry as an aid in developing drug products.
  • Bioequivalence Study Retention Samples. (1/12/2001)  Regulations state that applicants shall retain reserve samples of the tested products administered to study subjects and release these samples to FDA upon request. The Agency may then analyze these retention samples to ensure that the BA/BE results upon which FDA bases approval of New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDAs) are reliable.

  • Abbreviated New Drug Application Process. This web page includes all the information needed to assist with preparing and submitting ANDAs.

  • FDA Letters to Industry  This series of letters informs generic drug product manufacturers of policy and procedure developments with respect to the Drug Price Competition and Patent Term Restoration Act of 1984.

  • Generic Drug Review Process.  An interactive chart that provides an overview of CDER's abbreviated new drug application (ANDA) review process, and how CDER determines the safety and bioequivalence of generic drug products prior to approval for marketing.

Regulations for Abbreviated New Drug Application Submissions

Code of Federal Regulations
  • CFR 2.125  Use of chlorofluorocarbon propellants in self-pressurized containers
  • CFR 21 5.80  Approval of new drug applications and their supplements
  • CFR 21 10.30  Citizen Petition
  • CFR 21 10.45  Court review of final administrative action; exhaustion of administrative remedies
  • CFR 21 50  Protection of Human Subjects
  • CFR 21 56  Institutional Review Boards
  • CFR 310.305  Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications
  • CFR 314.70  Supplements and other changes to an approved application
  • CFR 320  Bioavailability and bioequivalence requirements
Federal Food, Drug, and Cosmetic Act
Food and Drug Administration Modernization Act of 1997
  • FDA Modernization Act of 1997: CDER-Related Documents.  The Food and Drug Administration Modernization Act (FDAMA), enacted Nov. 21, 1997, amended the Federal Food, Drug, and Cosmetic Act relating to the regulation of food, drugs, devices, and biological products.  The Act focuses on streamlining regulatory procedures, setting new priorities, entering into novel collaborative arrangements, and carrying out far-reaching managerial reforms within the Agency.  Please see the FDAMA Backgrounder for a summary of the most important provisions of the Act.  Please see the FDA Modernization Act home page for more information.

Back to Top

Paragraph IV Drug Product Applications: Generic Drug Patent Challenge Notifications

  • Paragraph IV List

    CFR 314.94(a)(12)(i)(A)(4)
    ...the applicant shall provide the patent number and certify, in its opinion and to the best of its knowledge, ...that the patent is invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the drug product for which the abbreviated application is submitted. The applicant shall entitle such a certification "Paragraph IV Certification".

Under the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, a company can seek approval from FDA to market a generic drug before the expiration of a patent relating to the brand name drug upon which the generic is based.  The first company to submit an Abbreviated New Drug Application (ANDA) with the FDA has the exclusive right to market the generic drug for 180 days.

To begin the FDA approval process, the generic applicant must: 1) certify in its ANDA that the patent in question is invalid or is not infringed by the generic product (known as "paragraph IV certification"); and 2) notify the patent holder of the submission of the ANDA.  If the patent holder files an infringement suit against the generic applicant within 45 days of the ANDA notification, FDA approval to market the generic drug is automatically postponed for 30 months, unless, before that time, the patent expires or is judged to be invalid or not infringed.  This 30-month postponement allows the patent holder time to assert its patent rights in court before a generic competitor is permitted to enter.

Back to Top

Generic Drug Petition Tracking

These petitions are submitted to FDA by drug companies seeking permission to file an abbreviated new drug application for a change from a listed drug in dosage form, strength, route of administration, or active ingredient in a combination product.   If FDA determines that the drug is suitable for a generic product, the petition is approved, if it is not suitable, the petition is denied.

Organization and Contact Information

Freedom of Information

  • The Freedom of Information web page provides access to information from advisory committees; clinical investigators; the Division of Drug Marketing, Advertising and Communications correspondence; drug approval packages; and warning letters.

How to Contact Us

OGD Mailing Address:

Office of Generic Drugs
Center for Drug Evaluation and Research
OGD Document Room
7500 Standish Place
Rockville, MD 20855

We highly recommend that firms consider submitting documents in electronic format. The OGD document room has limited space and resources to maintain paper documents.

We ask you to take time to communicate with CDER about this website. What information is and isn't useful to you?  Are there any additional items or categories of information you would like us to add?  Please e-mail Timothy W. Ames, timothy.ames@fda.hhs.gov with feedback about this site.

PDF symbol PDF requires the free Adobe Acrobat Reader

Back to Top     Back to Offices and Divisions

Updated: September 8, 2008
horizonal rule