Selecting an attorney for legal cases is a very important decision. Please enter your information below to receive a Free Consultation from an attorney in your area:
Drug Litigation News
Applicant Submits A Patent Covering The Formulation, Composition, Or Method Of Using An Approved Drug
Only certain types of patent information can be submitted to FDA. FDA publishes patent information on approved drug products in the Agency's publication Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book." The Orange Book is available on FDA's website and is updated every few weeks. The book is also printed yearly by the Government Printing Office, updated monthly, and is available to the public. It lists all approved drug products with their therapeutic equivalence codes in addition to the products' patent and exclusivity information (if such information exists).
Concerns have been expressed over FDA's role in the listing of patents in the "Orange Book." Under the FD&C Act, pharmaceutical companies seeking to market innovator drugs must submit information on any patent that: 1) claims the pending or approved drug or a method of using the approved drug, and 2) for which a claim of patent infringement could reasonably be asserted against an unauthorized party. Patents that may be submitted are drug substance (active ingredient) patents, drug product (formulation and composition) patents, and method of use patents. Process (or manufacturing) patents may not be submitted to FDA. FDA's final rule published on June 18, 2003, clarified the types of patents that must be listed in the Orange Book.
When an NDA applicant submits a patent covering the formulation, composition, or method of using an approved drug, the applicant must also submit a signed declaration stating that the patent covers the formulation, composition, or use of the approved product. The current required text of the declaration is described in FDA's regulations. The final rule replaces the signed declaration with a declaration form that must be used for the submission of patent information.
Many over the counter drugs were once prescription drugs
Americans buy about 5 billion over-the-counter drugs each year, according to government estimates, to treat their headaches, heartburn, coughs and colds, and other routine health problems. According to the Consumer Healthcare Products Association, a trade
Newsroom
News about Drug Litigation cases in Indiana and nationwide:
Study Shows Lag Time Study Shows Lag Time in Reporting Drug Withdrawal Decisions to Healthcare Professionals
Charlottesville, Va., May 23, 2006... Read more >
Drugs Into The U.S. Marketplace
It will focus in particular on whether certain "later-listed" patents or inappropriate patent submissions by the sponsors of innovator drug product... Read more >
Definition:
The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety
Over-the-Counter Drugs (OTC)
Definition:
FDA defines OTC drugs as safe and effective for use by the general public without a doctor's prescription.
Drug
Definition:
A drug is defined as a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Legal Disclaimers All attorney listings are a paid attorney advertisement, and do not in any way constitute a referral or endorsement by an approved or authorized lawyer referral service. The information provided on Indiana Drug Litigation.com is not intended to be legal advice, but merely conveys
general information related to legal issues commonly encountered. Your access
to and use of this website is subject to additional Terms
and Conditions.
Local Professional? Generate new business today
Call 866-227-9356 or contact a sales rep
Did You Know?