How To Delay Generics? Draw A Line On A Pill
October 10th, 2011 // 3:16 pm @ jmpickett
Here is a novel way to thwart generic competition. Simply add a so-called score, or line, across a tablet and the FDA may force generic rivals to rework their own versions, which amounts to a delay in approval. Meanwhile, the cash register at the brand-name drugmaker offices will keep ringing. That’s what Warner Chilcott hopes to accomplish by adding a score to its Doryx acne med.
The use of these lines would supposedly make it easier for patients to divide a Doryx tablet into thirds. And if Warner Chilcott succeeds, this may be the first time such a maneuver will have delayed generic rivals, according to The Wall Street Journal. “This is a new one,†Eileen Wood, vp of pharmacy and health-quality programs at CDPHP, a health plan in New York state, tells the paper.
The Doryx tablets had one score, which generic rivals planned to copy and sell by September 30, RBC Capital Markets analyst Shibani Malhotra tells the paper. However, on September 21, Warner Chilcott added a second score to its tablet and just two days later, filed a citizen’s petition asking the FDA to reject any copycat that lacked the new design.
In its petition filed, Warner Chilcott wrote that approving a generic with one score “would raise public health concerns.†The drugmaker argued that doctors might write a prescription for Doryx and instruct patients to divide its 150mg tablet into thirds, but patients would find it difficult to obtain the correct dose from a table with one score. “This could lead to patient confusion and sub-optimal dosing,†according to the petition (read it here).
Of course, timing is everything. In August, the FDA had just issued new draft guidance on scoring tablets and the sort of data that drugmakers need to submit on their applications to support scored tablets. The guidance was issued, in part, because a growing number of insurers and doctors are encouraging cash-strapped patients to split their meds.
“Consistent scoring ensures that the patient is able to adjust the dose, by splitting the tablet, in the same manner as the (brand-name drug), the FDA wrote. “This enables the patient to switch between products made by different manufacturers without encountering problems related to the dose. In addition, consistent scoring ensures that neither the generic product nor the (brand-name drug) has an advantage in the marketplace because one is scored and one is not†(read here).
Not surprisingly, this comes amid patent litigation in which Warner Chilcott has, so far, prevented Mylan Laboratories from selling a generic, the Journal notes. Last year, Doryx generated $172 million in sales and more than 383,000 patients in the US take the med, according to Wolters Kluwer Pharma Solutions data provided to the paper.
Source: Pharmalot
