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RegisterEMA: Q&A on biphasic MR products [BE/BA News]
Dear HS,
Patents are not assessed to any degree resembling the assessment at NCAs. I meant to say that in spite of all the trouble with variability and SPC's and food and all the other fancy stuff that matters in the PK-approval-agency-world, originator companies could try and patent the cuttoff or profile. If they were successful it would be game over for the generic industry for any MR covered by the patent regardless of other patent expiry:
First approval of one MR or other, then a year or two before generic competition is possible do a line extension (which does not necessarily require equivalence) to a formulation principle which is patented and which entails a cutoff or other such thingy, then cancel the MA for the original formulation and enjoy another x effective years of protection.
Best regards,
EM.
❝ Can be very tough. Early partial AUCs are always highly variable. No scaling for EMA… See this one (slides 51–56). Besides the CV, have a look at the PEs of the two studies of slide 54. All formulations got approval as hybrids (MR vs. IR + clinical studies). Interchangeability: ¡nada!
Patents are not assessed to any degree resembling the assessment at NCAs. I meant to say that in spite of all the trouble with variability and SPC's and food and all the other fancy stuff that matters in the PK-approval-agency-world, originator companies could try and patent the cuttoff or profile. If they were successful it would be game over for the generic industry for any MR covered by the patent regardless of other patent expiry:
First approval of one MR or other, then a year or two before generic competition is possible do a line extension (which does not necessarily require equivalence) to a formulation principle which is patented and which entails a cutoff or other such thingy, then cancel the MA for the original formulation and enjoy another x effective years of protection.
Best regards,
EM.
Complete thread:
- EMA: Q&A on biphasic MR products Helmut 2012-03-06 15:23 [BE/BA News]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: Q&A on biphasic MR products ElMaestro 2012-03-06 19:09
- EMA: Q&A on biphasic MR products Helmut 2012-03-07 03:52
- EMA: Q&A on biphasic MR productsElMaestro 2012-03-07 19:20
- EMA: Q&A on biphasic MR products Helmut 2012-03-07 03:52
- EMA vs. FDA d_labes 2012-03-07 10:26
- MPH examples Helmut 2012-03-07 14:22
- MPH examples d_labes 2012-03-07 16:18
- MPH examples Helmut 2012-03-08 01:07
- FDA more straight? d_labes 2012-03-08 08:29
- and what about power? ElMaestro 2012-03-08 11:37
- and what about power? d_labes 2012-03-08 13:26
- and what about power? Helmut 2012-03-08 13:36
- FDA more straight? Helmut 2012-03-08 12:51
- FDA more straight? luvblooms 2012-03-09 06:55
- Multiphasic MR ≠ DR Helmut 2012-03-09 12:18
- Multiphasic MR ≠ DR jag009 2012-03-28 15:29
- Metadate CD (30/70) Helmut 2012-03-28 15:45
- Multiphasic MR ≠ DR jag009 2012-03-28 15:29
- Multiphasic MR ≠ DR Helmut 2012-03-09 12:18
- FDA more straight? luvblooms 2012-03-09 06:55
- and what about power? ElMaestro 2012-03-08 11:37
- FDA more straight? d_labes 2012-03-08 08:29
- MPH examples Helmut 2012-03-08 01:07
- MPH examples d_labes 2012-03-07 16:18
- MPH examples Helmut 2012-03-07 14:22
- EMA: Q&A on biphasic MR products ElMaestro 2012-03-06 19:09
Ing. Helmut Schütz