Abuse Deterrent Products on the market: 6 and some things to consider when thinking of Elite's BE Studies:
1) Suboxone
2) Embeda (WHOOPS NO ITS NOT LOL LOL)
3) Opana
4) Oxycontin
5) Oxecta
6) Exalgo
The question becomes what would Elite most likely try to submit an Anda for???
Given the below I would have to go with Suboxone, followed by Opana and then Oxecta with an agreement that Actavis distributes the product exclusively. The interesting thing with this would be if Mik001 is a Hydromorph/Nal product this would leave Elite wide open to submit a generic Embdeda Anda. Though Elite would not want to do battle with Pfizer over legal matters. I stand with Suboxone and Mik001 being a Better Embeda.
1) Suboxone:
Regular Suboxone patent expired in 2009 and there is currently no generic version of it on the market. BioDelivery Science is in FDA NDA trials related to its own version of Suboxone and has shown good results so far. Given Elite's ART technology Elite may decide to put out a Better Suboxone with either Naltrexone and/or Nalaxone.....as Elite could do both in theory. In the interim, the originator of Suboxone, Reckitt Benckiser, interestingly removed its sublingual tablets from the market and put out Suboxone Film and has patent protection to around 2022. Reckitt stated that their Suboxone Film, as opposed to sublingual tablets, would be much less abused by children. They further asked the FDA to require any pharmaceutical company that is applying for a Suboxone Anda to ensure they have child safety measures accompanied (See Link). Clearly, this measure has more to do with curtailing competition than any ethical moral imperative. The FDA will surely be able to ask the question of why to discontinue the tablets when they did...AFTER their patent expired as opposed to earlier. Clear ploy as Reckitt still sells their sublingual tablets in Canada and the UK.
1) Suboxone
2) Embeda (WHOOPS NO ITS NOT LOL LOL)
3) Opana
4) Oxycontin
5) Oxecta
6) Exalgo
The question becomes what would Elite most likely try to submit an Anda for???
Given the below I would have to go with Suboxone, followed by Opana and then Oxecta with an agreement that Actavis distributes the product exclusively. The interesting thing with this would be if Mik001 is a Hydromorph/Nal product this would leave Elite wide open to submit a generic Embdeda Anda. Though Elite would not want to do battle with Pfizer over legal matters. I stand with Suboxone and Mik001 being a Better Embeda.
1) Suboxone:
Regular Suboxone patent expired in 2009 and there is currently no generic version of it on the market. BioDelivery Science is in FDA NDA trials related to its own version of Suboxone and has shown good results so far. Given Elite's ART technology Elite may decide to put out a Better Suboxone with either Naltrexone and/or Nalaxone.....as Elite could do both in theory. In the interim, the originator of Suboxone, Reckitt Benckiser, interestingly removed its sublingual tablets from the market and put out Suboxone Film and has patent protection to around 2022. Reckitt stated that their Suboxone Film, as opposed to sublingual tablets, would be much less abused by children. They further asked the FDA to require any pharmaceutical company that is applying for a Suboxone Anda to ensure they have child safety measures accompanied (See Link). Clearly, this measure has more to do with curtailing competition than any ethical moral imperative. The FDA will surely be able to ask the question of why to discontinue the tablets when they did...AFTER their patent expired as opposed to earlier. Clear ploy as Reckitt still sells their sublingual tablets in Canada and the UK.
