Today the last Advair Diskus patent expires
August 23, 2016
Great news: the last patent listed on the Orange book for Advair Diskus is expiring today!
The pediatric extension of US patent US5873360 is expiring today. There is therefore as of today no unexpired patent in the way of generic entry. Sadly, this is not saying that the development and filing of a generic Advair Diskus is any easier as of today. API know-how, unstable formulations, highly variable RLD are still significant hurdles. My recent post on the RLD variability (link to BE equivalence blog) showed documented evidence that the originator would itself not pass the stringent FDA bioequivalence requirements.
Although the patents have expired, residual I.P. exists on registered design of the device shapre and trademark on the original product color. This I.P. protection is not consistent across the globe allowing for easier filings in some geographies. It is a credit to GSK to have managed to fence off competition for so long, although it might have had a soupçon of chance.
Generic Advair Diskus runners up
Who has made it to the finish line on patent expiry? No one in the US, a few in Europe and the rest of the world. Some with products of dubious bio-equivalence profiles.
It is well known that no company has managed to have a 505j generic Advair Diskus approved in the US yet. Hikma/Vectura filed earlier this year, just a moment after Mylan. The rumor mill has it that Vectura filed a fanciful in vivo study, why Mylan rushed and is not ready to launch the product commercially. I have no idea if any of this is true, but aren’t rumors fun? I wish them fun all the same. Good luck to Walter and his team, he is a brilliant and delightful chap.
So we are left to look at Europe, where Celon filed a substitutable generic in Poland a few years back, Sandoz filed in Germany and other countries the Vectura (well done again) Gyrohaler, now known as Airflusal Forspiro. In Greece, Elpen launched the Elpenhaler, while in Turkey Neutec filed the Discair, and Sanovel filed the Cyplos Savohaler. Further afield, in India Cipla filed the Multihaler, and in Korea Korean United Pharmacy briefly had a product called Sereterol Activair on show. Let’s not forget the TEVA Spyromax filing in Europe.
Advair Diskus is not short of further competitors in the US and EU: TEVA/Actavis, Oriel, Lupin, Glenmark all dying to make a splash. Further afield in China Hisun, Synmosa and Sichuan Purity are all in the race. I shan’t mention Australia and other countries, as I am running out of space. There is much work to do to close in on Advair Diskus, I wish you all the best of luck and do be in touch, you know you need help to crack this and accelerate your filing.
The best device to use is of course Merxin MRX001: a very well kept secret. I shall entertain you with this story another time.
This is so exciting I can barely contain myself, so I shall put on the 2015 Bayreuth recording of Der Fliegende Hollander and think about the immortality of Love.
Love you all.
Will be back soon.
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