Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

likely correct that Elite failed a BE study on Concerta years ago

Concerta is difficult to manufacture, and there are abuse-resistance issues. FDA may expect any generic to at least be as abuse-deterrent as the brand name comparator. So, there are at least two significant hurdles for any company trying to get approval and market generic Concerta.


https://www.fda.gov/drugs/drug-safety-and-availability/methylphenidate-hydrochloride-extended-release-tablets-generic-concerta-made-mallinckrodt-and-kudco

UPDATE [10-17-2016 and 11-4-16] FDA proposes to withdraw approval of two generic versions of Concerta (methylphenidate hydrochloride)

The FDA is proposing to withdraw approval of two generic versions of Concerta (methylphenidate hydrochloride) extended-release (ER) capsules, used to treat attention-deficit hyperactivity disorder. Mallinckrodt Pharmaceuticals and UCB/Kremers Urban (formerly Kudco) the companies that make the generic products, have failed to demonstrate that their products provide the same therapeutic effect as (are bioequivalent to) the brand-name drug they reference.

This action is related to steps the FDA took in November 2014. At that time, the FDA announced that, based on an analysis of data, it had concerns that the Mallinckrodt and Kudco (now UCB/Kremers Urban) products may not produce the same therapeutic effects as Concerta. At that time, the FDA requested that Mallinckrodt and Kudco either (1) voluntarily withdraw their products from the market and request that FDA withdraw approval of their product’s Abbreviated New Drug Applications (ANDAs) or (2) within six months, provide data to confirm that their products are bioequivalent to Concerta consistent with the revised draft guidance for industry for bioequivalence testing for these products.

At that time, the FDA changed the Orange Book therapeutic equivalence code for these two products from AB (indicating therapeutic equivalence) to BX (data are insufficient to determine therapeutic equivalence).

WeeZuhl 9/29/19:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151418370

Brand name Concerta (methylphenidate ER) has a special formulation called "OROS" (osmotic-release oral system), but the generic versions of Concerta do not use OROS. The manufacturer, Mannheim, has always inferred that the OROS formulation makes it very difficult to extract MPH for abuse. And I suspect it does. I would bet that brand name Concerta, without any further modification, could do pretty well in a HAL snorting study and would perform much better than its generic equivalents in extraction studies for simulation of IV abuse. I would bet brand name Concerta would qualify for an ADF label as it exists right now, and I would bet every one of the generic versions of Concerta would fail the exact same HAL studies. Under this scenario, it would not be far-fetched to see FDA keep brand name Concerta while discontinuing the generics.

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