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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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 (Posted 10/18/2004)
In the absence of influenza vaccine, many health practitioners and
patients will turn to the use of drug products such as amantadine
hydrochloride and rimantadine hydrochloride which are approved for
the prophylaxis and treatment of illness caused by various strains
of the influenza virus. Fortunately, both of these drugs are
available from multiple generic sources.
In an effort to assure that adequate quantities of these products
will be available for use by the American public, the Office of
Generic Drugs (OGD) is granting "expedited review" status to all
pending supplements in the review queues for all dosage forms of
these two drug products. This policy will be in effect for 90 days
and will be reassessed as necessary.
- Presentations from the Generic Pharmaceutical Association's
Annual Meeting, February 29- March 2, 2004. (Posted 3/5/2004)
- Update from the Office of Generic Drugs, Gary J. Buehler,
Director, Office of Generic Drugs. [PPT
slides] or [HTML]
- Office of Generic Drugs: Some Scientific Initiatives, Lawrence
Yu, Ph.D., Director for Science, Office of Generic Drugs. [PPT
Slides] or [HTML]
- The Inactive
Ingredient Database has a new feature. On the main search page,
click on "About this Database." Question 11 has a downloadable
zipped text file, IIGZIP.EXE, that is used for the query. The file
can be downloaded, imported into Access or Excel, for sorting,
analysis, reports, etc. The link is:
http://www.fda.gov/cder/iig/iigfaqWEB.htm"
(2/9/2004)
- Previous News items
| Recent
Federal
Register Notices |
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- Determination That Serzone (Nefazodone
Hydrochloride) Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness, Notice [TXT]
[PDF]
- Summary: The Food and Drug Administration (FDA) has determined
that Serzone (nefazodone hydrochloride (HCl)) was not withdrawn from
sale for reasons of safety or effectiveness. This determination
means that FDA will not begin procedures to suspend approval of
abbreviated new drug applications (ANDAs) for nefazodone HCl, and
FDA may continue to approve ANDAs for nefazodone HCl. (Posted 10/26/2004)
Application of
30-Month Stays on Approval of Abbreviated New Drug Applications and
Certain New Drug Applications Containing a Certification That a
Patent Claiming the Drug Is Invalid or Will Not Be Infringed;
Technical Amendment. [TXT]
[PDF]
Effective date: March 10, 2004 (Posted
3/10/2004)
Over-the-Counter Drug Products; Safety and Effficacy Review;
Additional Dandruff Control Ingredient. [TXT]
[PDF]
Comments due May 18, 2004. (Posted
2/20/2004).
Determination That Chlorthalidone Tablets and Seven Other Drug
Products Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness. [TXT]
[PDF]
(Posted 2/20/2004).
Previous Federal Register
items
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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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You may now submit ANDAs in electronic format in place of paper. We have placed the ANDA on public docket 92S-0251 as a submission acceptable in electronic format as allowed under 21 CFR Part 11. It should be noted that Part 11 requires that datasets provided in electronic format and used in the review process meet the requirements for archiving, i.e., protection of those records to enable their accurate and ready retrieval throughout the records retention period.
Electronic datasets, including those accompanying a paper submission cannot be considered as official and used to support the application if they are submitted in a file format that is not
archivable. As FDA and industry progress in meeting the goals of use of electronic submissions, compliance with electronic submission regulations will be expected. Typically, electronic datasets accompany an ANDA application to support the review of bioequivalence studies. With the implementation of the guidance for industry Providing Regulatory Submissions in Electronic Format – ANDAs (June 2002), the submission of these dataset records for use in the review should be in archivable format. At this
time, the archival dataset format is SAS Transport. (Posted
7/15/2002)
- 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''.
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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: November 2, 2004
Originator: OTCOM/DLIS
HTML by SJW
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10/26/2004