Eighteen states and the District of Columbia have filed suit against Abbott Laboratories and Solvay’s Fournier Industrie et Santé and Laboratories Fournier for allegedly entering into a scheme to block the generic version of the cholesterol lowering drug TriCor® (fenofibrate), indicated for the treatment of hypercholesterolemia and hypertriglyceridemia.
According to the AGs in the states, the companies made trivial changes to the formulations of TriCor, and marketed those while withdrawing the original drug from the market. The companies deleted references to the original forms of the drug from national drug databases, according to prosecutors, making it more difficult for a generic version of TriCor to obtain generic status
The states filed their lawsuit in federal court in Wilmington, Delaware, accusing Abbott and of undermining efforts to bring generic drugs to market by patenting new formulations of TriCor with only minor changes to the drug.
TriCor, which costs more than $3 a pill, generated sales of $1.2 billion for Abbott in 2007, but the company, according to the lawsuit, has tried to maintain a monopoly on the market by obtaining term-extending patents. Abbott denies the allegations saying it has not prevented other fenofibrate drugs from being marketed.
The prosecutors say Fournier obtained patents covering the variations of TriCor and then filed patent infringement lawsuits against generic companies that tried to compete. The litigation meant that the Food and Drug Administration could not approve generic versions of TriCor.
In a long-running battle with Teva Pharmaceutical, Abbott has tried to stay one step ahead of the generic entry. Originally, Teva filed an ANDA for ANDA for a TriCor capsule formulation and made a Paragraph IV certification that U.S. Pat. No. 4,895,726 was invalid so not infringed. A bbott sued and initiated a 30-month stay of FDA approval.
While the capsule battle was continuing, Abbott filed a new NDA for 54 mg and 160 mg TriCor in a tablet formulation arguing that the tablet was bioequivalent to the capsule. After this was approved, Abbott stop selling the capsules and bought back all the capsules from the market.
The Abbott, in a move that was probably too smart for their own good, changed the code for TriCor capsules in the National Drug Data File (NDDF) to “obsolete.” The NDDF is a private database that provides information about FDA-approved drugs. Changing the code to obsolete then removed the TriCor capsule drug formulation from the NDDF, which prevented pharmacies from filling TriCor prescriptions with a generic capsule formulation.
Needless to say, Teva took it kind of hard and added antitrust counterclaims to its suit against Abbott. Abbott is no longer marketing the 54 mg and 160 mg strength tablets because it has now changed its Tricor product to 48 mg and 145 mg strength tablets. Abbott even filed a new NDA for 48 mg and 145 mg TriCor tablets looking to change the label to state that the new tablets do not need to be taken with food (the dissolvable version).
Teva claims that Abbott’s actions have frustrated generic competition in Fenofibrate products through a combination of two market conversions and the gaming of the Hatch-Waxman Act, denying consumers access to a generic alternative to Abbott’s products.
The dissolvable version of TriCor retains patent protection until 2018.
In the current suit by various AGs, the states involved are Arizona, Arkansas, California, Connecticut, the District of Columbia, Florida, Iowa, Kansas, Maine, Maryland, Minnesota, Missouri, Nevada, New York, Oregon, Pennsylvania, South Carolina, Washington, and West Virginia.
No word yet on when Abbott’s new magic orange-colored TriCor comes out.
[…] despite having previously granted …http://www.smu.edu/csr/articles/2003/Winter/Gratton.pdfAGs Feel Chest Pains Over Generic TriCor – Patent BaristasThe dissolvable version of TriCor retains patent protection until 2018. In the current suit by […]
Hi guys have few questions
What kind of approval did Abbot take for tricor tablets, the fda site says it was an NDA does that mean 505b2 or actual patent, and how long is the exclusivity?
Abbott’s Tricor@ fenofibrate tablets were approved for sale by the FDA under NDA No. 21-203 as a 505(b). I believe that it was a 505(b)(1).
The difference between a 505(b)(1) and 505(b)(2) NDA is that while the standard for approval (substantial evidence of safety and effectiveness) is the same, the source of the data is different.
Under 505(b)(1), the source of data is your data (you did the studies or own the data) or you have right of reference (permission) to use the data.
Under 505(b)(2) 505(b)(2) the applicant relies upon data you don’t own or have right of reference to, including published literature
Can anyone confirm if this was 505(b)(1)?
Thanks Stephen for your so quick response, I apperecite it!I was wondeering how does one get to know that the filling was a 505 b ..is there any pointer to that in fda site or orange book?
thanks again
[…] Over generic tricor &8221 … pdfAGs Feel Chest Pains Over generic tricor – Patent BaristasThe …https://patentbaristas.com/archives/2008/03/21/ags-feel-chest-pains-over-generic-tricorPro-Life Doctors Need Not Apply Are we advancing or regressing as a culture? abilify price accutane […]
Re: 505(b)(1) or (b)(2), Abbott licensed the product from Laboratories Fournier. Thus, Abbott had the rights to the data, making this a (b)(1). as Stephen indicates, a (b)(2) is used when data that is needed for approval is not owned by the applicant.
For 505(b)(2) fans, this saga provides instructive support to the idea that small changes to an innovator product a) can be patented and b) can have a healthy market.
[…] Recall that fenofibrate is a 30+ year-old drug. Abbott introduced the product as a capsule. Teva filed an ANDA and Abbott sued, triggering the 30-month stay. During this stay, Abbott introduced a tablet version and withdrew the capsules, nullifying Teva’s generic. Teva then filed an ANDA for the tablets. Abbott sued, again triggering the 30-month stay during which it changed the dose, nullifying, once again, Teva’s generic. Teva enlisted 25* state attorneys general to file a suit in federal court in Delaware alleging that Abbott has illegally used “product switching” to avoid generic competition. A more legal-based review is here. […]
[…] As of July 2008, twenty-five states and the District of Columbia have filed antitrust suits against Abbott Laboratories and Solvay’s Fournier Industrie et Santé and Laboratories Fournier in Delaware District Court, charging them with blocking generic competition by engaging in product hopping, among other “anti-generic strategies.” Patent Baristas reported the initial filing here. […]