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
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
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:
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".
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- FDA has established Docket No. FDA-2008-N-0483 for comments regarding 180-day generic drug exclusivity for Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution. Anyone wishing to comment on this subject should submit their comments to the Federal Dockets Management System located at regulations.gov and reference the docket number. FDA will be accepting comments until September 19, 2008. You may contact the Public Reading Room of the Division of Dockets Management at 301-827-6860 if you have any questions.
- USP Chapter <467> Residual Solvents - Additional Information Additional information clarifying the Office of Generic Drugs expectations regarding implementation of USP <467>.
- Residual Solvents Acceptability Letter
- FDA and Generic Drugs: An Interactive Forum
A special FDA conference for industry, co-sponsored by the University of Rhode Island, College of Pharmacy, focusing on effective communications, addressing ANDA deficiencies and the current legal landscape regarding ANDAs.
- CDER issues "Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg"
- Decisions related to PUBLIC LAW 108–173, DEC. 8, 2003, Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003
- FDA requests comments regarding the forfeiture of 180-day generic-drug exclusivity for acarbose under Title XI of the MEDICARE PRESCRIPTION DRUG,IMPROVEMENT, AND MODERNIZATION ACT OF 2003 (MMA). All comments should be submitted to Docket No. 2007N-0417. FDA has extended the deadline for response until November 12, 2007.
- FDA has established Docket No. 2007N-0389 for comments regarding 180-day generic drug exclusivity for granisetron hydochloride injection. Anyone wishing to comment on this subject should submit their comments to the FDA's Division of Dockets Management and reference the docket number. FDA will be accepting comments until October 31th, 2007. The submission will be on public display in the Divison of Dockets Management, Room 1061, Mail Stop HFA-305, 5630 Fishers Lane, Rockville, MD 20852.
- Generic Initiative for Value and Efficiency (GIVE)
- FDA has established Docket No. 2007N-0382 for comments regarding 180-day generic drug exclusivity for ramipril capsules. Anyone wishing to comment on this subject should submit their comments to the FDA's Dockets Management Branch and reference the docket number. FDA will be accepting comments until October 19th, 2007. The submission will be on public display in the Dockets Management Branch, Room 1061, Mail Stop HFA-305, 5630 Fishers Lane, Rockville, MD 20852.
- Beginning October 1, 2007, all newly received Abbreviated New Drug Applications (ANDAs) will be numbered sequentially in the 90-000 series including those that previously would have been numbered in the 40-000, 60-000, 70-000 and 80-000 series. This will further streamline the receiving process for ANDAs.
- Guidance for Industry: Individual Product Bioequivalence Recommendations
- FDA addresses issues on Amlodipine Abbreviated New Drug Application Approvals
- Orange Book FR Safety or Effectiveness Determinations List (7/22/2008) The following is a list of approved drug products that have had Federal Register Citizen Petition Notices stating that the FDA has determined that the approved drug product was not discontinued for safety or effectiveness reasons. Under § 314.161(a)(1) [21 CFR 314.161(a)(1)], the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. The Federal Register Notice will allow FDA to approve applications (ANDAs) for the product if all other legal and regulatory requirements are met. The list is from 1995.
- FDA Notifies Pharmaceutical Companies to Confirm or Repeat Analytic Studies Used in the Approval of a Number of Drug Products. Information (1/10/2007)
- Manual of Policies and Procedures (MaPP): 5240.3R Review Order of Original ANDAs, Amendments, and Supplements
- FDA's Clarification of Aripiprazole Tablets' Bioequivalence Requirements
- FDA's Clarification of the Patent Status for Simvastatin
- FDA's Clarification of Pravastatin's Exclusivity
- Presentations from the Generic Pharmaceutical Association's 2006 Annual Meeting Business Exposition, February 16-18, 2006. (3/7/2006)
- "Update from the Office of Generic Drugs" , Gary J. Buehler, Director, Office of Generic Drugs.
- "Update to the GPhA Technical Advisory Committee" , Gary J. Buehler, Director, Office of Generic Drugs.
- "Regulatory Assessment of Pharmaceutical Quality for Generic Drugs" , Lawrence Yu, Ph.D., Director for Science, Office of Generic Drugs.
- "Generic Labeling 2006" , Koung Lee, Reviewer, Labeling Review Branch, Division of Labeling and Program Support, Office of Generic Drugs.
- Previous News items
- 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)
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
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- 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.
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- 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:
- (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.
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- 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
- 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.
- 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.
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.
|Code of Federal Regulations
- CFR 2.125 Use of chlorofluorocarbon propellants in self-pressurized containers
21 5.80 Approval of new drug applications and their supplements
21 10.30 Citizen Petition
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
310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications
314.70 Supplements and other changes to an approved application
- CFR 320 Bioavailability and bioequivalence requirements
|Federal Food, Drug, and Cosmetic Act
- Draft Guidance forIndustry: Applications Covered by Section 505(b)(2). Optional format: PDF. (Issued 10/1999)
- 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)
- Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. (Issued 3/2000)
- Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act. (Issued 9/1999). 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
...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.
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, email@example.com with feedback about this site.
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