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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
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You can search for generic equivalents by using the "Electronic Orange Book" at http://www.fda.gov/cder/ob/default.htm 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" at http://www.fda.gov/cder/ogd/approvals/default.htm.
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- (11/29/2005) On November 29, 2005, CDER rescinded the November 18, 2005 approval of Kali Laboratories' ANDA 76-506 for Ondansetron Orally Disintegrating Tablets, 4 mg and 8 mg. The reference listed drug for this ANDA is Zofran (GlaxoSmithKline), which is used to treat nausea and vomiting. CDER took this action because the U.S. District Court for the District of New Jersey issued a decision finding that this ANDA infringes a patent of GlaxoSmithKline that has not yet expired. Pediatric exclusivity attaches to this patent, and is not due to expire until December 24, 2006. Kali has informed CDER that Kali has appealed this court decision.
- Presentations from the Generic Pharmaceutical Association's Fall Technical Conference, October 24-26, 2005, Washington, DC. (11/8/2005)
- "OGD Perspectives," Gary J. Buehler, Director, Office of Generic Drugs. [PPT]
- "Question-Based Review: An Enhanced Pharmaceutical Quality Assessment System," Lawrence Yu, Ph.D., [PPT]
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| Recent Federal Register Notices |
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- 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)
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.
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- ANDA Checklist for Completeness and Acceptability [PDF] [Word] (
 1/17/2006)
- 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 web page. 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.
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| 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 |
- Draft Guidance for Industry: Applications Covered by Section 505(b)(2). Optional format: PDF. (Issued 10/1999, Posted 12/7/1999)
- Drug Price Competition and Patent Term Restoration Act of 1984
- Guidance for Industry: 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act
 (Issued 6/1998, Posted 6/22/1998)
- Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. (Posted 3/27/2000)
- Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act. (Issued 9/1999, Posted 10/4/1999). The FDA Modernization Act of 1997 permits certain applications to obtain an additional six months of marketing exclusivity (pediatric exclusivity) if, in accordance with the requirements of the statute, the sponsor submits requested information relating to the use of the drug in the pediatric population.
- Useful pediatric exclusivity links. This information is provided to assist generic drug applicants in determining whether a drug product might be or is subject to pediatric exclusivity.
| 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.
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- 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.
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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.
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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, amest@cder.fda.gov with feedback about this site.
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