Replies to post #247757 on Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

So Epic/PuraCap and whatever other handful of companies already had their OxyContin ADT ANDAs filed with the FDA, right? And now that the patent litigation (11/2016) is no longer an obstacle, they could theoretically get approval at any time? Any way to know when their ANDA was filed?

Furthermore, if that's the case... if Elite and PuraCap worked out a deal to sell PuraCap's version, wouldn't Elite and PuraCap end up competing with each other once Elit

I don't know the details of any of the ANDAs. OxyContin has some remaining FDA exclusivity until 2018/9, granted for a pediatric safety study that added additional information to the official label. FDA could theoretically start giving approvals any day, but they would have to allow for the pediatric safety information to be left off the label. Sometimes FDA will not give any approvals until the pediatric exclusivity has expired. I think OxyContin is exactly that kind of situation. However, FDA did allow for a "carved out label" with Collegium Xtampza. It says that safety has not been established in the pediatric population, even though it really has. That is usually a no-no with pediatric data.


Xtampza was an NDA not ANDA, so different rules apply, and totally different review cycles. But like Collegium, the handful of companies who have successful Paragraph IV patent challenges can reasonably expect their ANDAs to be approved soon. This is because the Hatch-Waxman Act says pediatric exclusivity cannot be used against an application with a favorable court decision. The pediatric section of their label will look like Xtampza's until the pediatric exclusivity expires (see below).


I am not convinced Elite will file a generic OxyContin ANDA in the near future. I don't think Purdue is done filing lawsuits against challengers (see Amneal suit 3/1/17). That may not be the most efficient use of capital at this time. But I do think Elite's new factory is a finely-tuned OxyContin machine. Nasrat and Doug Plassche are ready to start pumping out PuraCap's generic OxyContin as soon as the Epic ANDA is approved. If that happens, no one will care about when they get around to filing their own ANDA and picking a fight with Purdue.


In my lunatic opinion, Elite's new factory is going to be busy soon. Generic OxyContin, generic Norco, generic Percocet and SequestOx all could potentially come on-line within the next year. And it could start at any time. Short-term outlook is great with pending FDA ANDA approvals upcoming SequestOx results, but I am also hoping to hear about a new agreement with PuraCap in the near future.




Xtampza's carved-out label:


http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208090s000lbl.pdf

8.4 Pediatric Use
Safety and effectiveness of XTAMPZA ER in pediatric patients below the age of 18 years have not been
established.

OxyContin Label:

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022272s027lbl.pdf

8.4 Pediatric Use
The safety and efficacy of OXYCONTIN have been established in pediatric patients ages 11 to
16 years. Use of OXYCONTIN is supported by evidence from adequate and well-controlled
trials with OXYCONTIN in adults as well as an open-label study in pediatric patients ages 6 to
16 years. However, there were insufficient numbers of patients less than 11 years of age enrolled
in this study to establish the safety of the product in this age group.
The safety of OXYCONTIN in pediatric patients was evaluated in 155 patients previously
receiving and tolerating opioids for at least 5 consecutive days with a minimum of 20 mg per
day of oxycodone or its equivalent on the two days immediately preceding dosing with
OXYCONTIN. Patients were started on a total daily dose ranging between 20 mg and 100 mg
depending on prior opioid dose.
The most frequent adverse events observed in pediatric patients were vomiting, nausea,
headache, pyrexia, and constipation [see Dosage and Administration (2.1), Adverse Reactions
(6.1), Clinical Pharmacology (12.3) and Clinical Trials (14)].