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.
Drug companies spend more on marketing than R&D
The top 10 drug companies spent nearly three times more on marketing, public relations and administration than they did on research and development.
Newsroom
News about Drug Litigation cases in Indiana and nationwide:
Pending Generic Drug Applications
If a patent is listed in the "Orange Book," an applicant seeking approval for an ANDA must submit a certification to the patent. Even an applicant ... Read more >
Definition:
A Reference Listed Drug is an approved drug product to which new generic versions are compared to show that they are bioequivalent.
Pharmaceutical Equivalents
Definition:
FDA considers drug products to be pharmaceutical equivalents if they meet these three criteria: they contain the same active ingredient(s), they are of the same dosage form and route of administration and they are identical in strength or concentration.
Dosage Form
Definition:
A dosage form is the physical form in which a drug is produced and dispensed, such as a tablet, a capsule, or an injectable.
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?