The trouble all started back in September 2011 when Warner Chilcott filed a citizen petition with FDA asking the agency not to accept generic applications for its severe acne treatment without the extra score line, which the company claimed made it easier for patients to divide and take the tablets in thirds [1].

In its citizen petition, Warner Chilcott said that approving generics with only one score ‘would raise public health concerns’. The drugmaker argued that doctors might instruct patients to divide the Doryx tablet into thirds, but a generic version with just one score would make it difficult to get the right dose, leading ‘to patient confusion and sub-optimal dosing’.

Mylan was just one of the generics companies reported to be ready to launch in September 2011 with single-score generics of the acne treatment.

The tactic from Warner Chilcott followed the release of new draft guidance from FDA in August 2011 on scoring tablets, which highlighted the importance of ‘consistent scoring’ in order to ‘ensure that the patient is able to adjust the dose, by splitting the tablet, in the same manner’ as the originator drug.

FDA denied the petition for reasons including those listed below:

• A generic single-scored product ‘would not raise any new public health concerns’, especially since the two products (single and dual-scored) would only be available ‘for a finite period of time’.
• In contrast with chronic diseases ‘where patients may need to titrate their dose of medication based on changing disease state or changing response to therapy over time’, the dose of doxycycline hyclate ‘would rarely be adjusted in this manner’.
• The risk of medication error because of different scoring configurations would be limited as doses of doxycycline hyclate are not typically adjusted based on a patient’s response after the initial prescription.
• The single- and dual-score products are currently being sold by the originator company.

FDA approved Mylan’s ANDA for generic doxycycline hyclate on 8 February 2012, with a post-approval requirement to comply with the new dual scoring of the reference product when it conducts its next manufacturing run.

The approval of Mylan’s ANDA comes amid ongoing patent litigation. On 22 September 2011, Warner Chilcott announced that it had been granted a preliminary injunction against generics giant Mylan by the US District Court in New Jersey preventing Mylan from launching a generic version of Doryx. Warner Chilcott alleges that Mylan is guilty of infringing on its ‘161 patent’ for Doryx which expires in 2022.

Mylan has agreed that it will not launch its generic Doryx product until after a decision is issued regarding the lawsuit. The trial is underway in the US District Court for the District of New Jersey and a decision is currently expected in March 2012.

There is much at stake. More than 383,000 patients in the US alone take Doryx. In 2011, Doryx had US sales of approximately US$264 million, according to IMS Health.

Editor’s Comment

FDA has clearly made a stand in this case, but what happens when the case involves a drug for a chronic disease where patients may need to adjust their dose of medication? Does this mean that originator companies can use this tactic to delay competition from generics?

Please feel free to share your thoughts via email or in the comments section below. What are your views on such tactics? Do you think that FDA should provide clearer guidance on this issue? 

Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Drawing score lines on pills to delay generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 24]. Available from: www.gabionline.net/Pharma-News/Drawing-score-lines-on-pills-to-delay-generics