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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 bioequivalence and generic drugs, please see the chapter,
"FDA Ensures Equivalence of Generic Drugs" in FDA's 1999 special report From Test Tube to Patient:
Improving Health Through Human Drugs.  |
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| Recent Federal
Register Notices |
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- Labeling Updates. This web page provides information on
recently approved labeling changes for Reference Listed Drug products from 1998 to the
present.
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- 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.
- Inactive Ingredient Guide
- Abbreviated New Drug Application web page.
This web page includes all the information needed to assist with preparing and submitting
ANDAs.
- Electronic ANDA Submissions. This
web page includes registration, software, user documentation and training information for
ANDA electronic submissions.
- 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 Database (1/18/2001)
CFR
319.94(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''.
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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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FDA/Center
for Drug Evaluation and Research
Last Updated:January 18, 2001
Originator: OTCOM/DLIS
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