Medicine rushed to market before patents are settled
By Julie Schmit USA TODAY
The launch at riskstrategy means the generic-drug maker would be liable for damages if it were to lose a patent case. Companies take that chance because of intense competition to be first with generics of blockbuster drugs and their increased confidence of winning patent disputes.
Drug Makers Introducing Generic Medications While Patent Claims Still Being Considered in Court
USA Today on Tuesday examined the increasing trend of generic drug companies releasing lower-cost versions of brand-name medicines while "fighting patent claims in court." The "launch at risk" strategy can result in a generic drug maker being liable for damages if it loses a patent case, but companies are accepting the risk because of the "intense competition" in the generic industry and their "increased confidence of winning patent disputes," USA Today reports. Drug companies usually have 20 years to develop and market a medication without facing generic competition, and 30 additional months during patent litigation when they can keep disputed generic drugs off the market. FDA-approved generics can be marketed after the 30-month period, even if the brand-name drugs' patents remain under dispute. The first generic drug launched for a brand-name version can win 70% of the market in the first six months, when other generics are prevented from release, according to USA Today.
Adams Respiratory Therapeutics Comments on Possible ANDA Filing of an Extended-Release Formulation of Guaifenesin Thursday August 17, 7:28 pm ET
CHESTER, N.J., Aug. 17 /PRNewswire-FirstCall/ -- Adams Respiratory Therapeutics, Inc. reports today that it has been contacted by a company claiming to have submitted an Abbreviated New Drug Application (ANDA) to the Food and Drug Administration (FDA) for a single-ingredient extended-release formulation of guaifenesin.
Mucinex® is the only FDA-approved, extended-release, single-ingredient guaifenesin product. Adams believes that there are at least two hurdles for this competitor to enter the OTC market. First, Adams' NDA approval of Mucinex® was based on rigorous scientific criteria. Adams will urge the FDA to apply these same scientific standards to this ANDA filing as it applied to the Company's NDA filing for Mucinex®.
Secondly, Adams has two patents that protect its suite of extended-release bi-layer tablet products. These patents are listed in the FDA Orange Book and expire in 2020.
