Close
Blog & Resources Camargo Blog February 11th, 2013

No 5-Year Exclusivity for Combinations Drugs with an NCE

One anomaly to the exclusivity rules is that a combination drug product containing a new chemical entity (NCE) and one or more previously approved drugs does not receive the 5-year exclusivity that a single-component NCE drug would receive. Thus, Ferring Pharmaceuticals Prepopik (sodium picosulfate, citric acid and magnesium oxide) was approved as a 505(b)(2) in July, 2012, but was awarded 3 years of exclusivity, despite the NCE status of sodium picosulfate.

Ferring has filed a Citizen Petition (CP) challenging this determination. The thrust of the argument is a bit narrow, in that sodium picosulfate cannot be approved as a single agent since the FDA determined that it requires the presence of magnesium citrate (stemming from magnesium oxide and citric acid) to fully function.

Similarly, Gilead filed a Citizen Petition requesting 5-year exclusivity for its HIV treatment Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir). Neither elvitegravir or cobicistat have been previously approved by FDA, whether alone or in combination. Stribild was filed first, but Gilead has also filed NDA’s for the two actives. The CP shows that based on current FDA policy, Stribild and the individual active drugs will all receive 3-year exclusivity, a result, it is argued, that Congress did not intend.

The Gilead CP documents the genesis of the exclusivity provisions in 21 USC 355(c)(3)(E)(iii) and 355(j)(5)(iii), noting that FDA has always interpreted the law to mean that if a combination product contains any previously approved active moiety, then only 3-year exclusivity can apply. Gilead then goes on to request that FDA change this longstanding interpretation.



Get Our Expertise Working for You

To learn how you can benefit from our regulatory and strategic development expertise, view our solutions or contact us.


Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.


Contact
Headquarters
9825 Kenwood Road
Suite 203
Cincinnati OH, 45242
Durham Office
2505 Meridian Parkway
Suite 150
Durham NC, 27713
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights