Elite Pharmaceuticals Inc (ELTP)

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$ELTP SequestOx and ADF Patents

Elite Announces U.S. FDA Priority Review Designation for SequestOx™ NDASequestOx™ NDA Submission Accepted for Review
GLOBENEWSWIRE 7:00 AM ET 3/17/2016
Symbol Last Price Change
ELTP 0.2995down 0 (0%)
QUOTES AS OF 03:59:37 PM ET 03/16/2016
NORTHVALE, N.J., March 17, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc.(ELTP) ("Elite" or the “Company") today announced that the New Drug Application (NDA) for SequestOXTM (ELI-200), Elite’s lead opioid abuse-deterrent candidate for the management of moderate to severe pain where the use of an opioid analgesic is appropriate, has been accepted and granted priority review by the United States Food and Drug Administration (“FDA”). The FDA has set a target action date under the Prescription Drug User Fee Act (“PDUFA”) of July 14, 2016.

SequestOxTM is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone which incorporates 5 mg, 10 mg, 15 mg, 20 mg and 30 mg doses of oxycodone into capsules.

“The FDA’s decision to grant Priority Review to the SequestOxTM submission is an important milestone for Elite and an important step toward providing a new treatment option for physicians and patients that may deter some of the common methods of opioid abuse,” said Nasrat Hakim, President and Chief Executive Officer of Elite. “I am pleased with the targeted PDUFA date and we look forward to the FDA’s review of our submission.”


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Elite’s 1st Generation ADF Patents and their Purpose

Many Shareholders have asked that I post a simple easy to read non-technical clarification of $ELTP 1st generation 3 Patents.



Elite’s 1st Generation Patents

8,182,836 Patent….Patent Application 12/478,952
8,425,933 Patent….Patent Application 12/640,344
8,703,186 Patent….Patent Application 13/863,764



8,182,836 Patent….Patent Application 12/478,952

This is the 1st of the Triple Patents and has been awarded to $ELTP based on its ADT Pharmacological approach of neutralizing opioid agonist abuse with an opioid antagonist that have been administered together.



8,425,933 Patent….Patent Application 12/640,344

This is the 2nd of the Triple Patents and has been awarded to $ELTP based on its 2-bead modular approach of identical physical attributes for separate agonist bead and an antagonist bead. This 2-bead tech is $ELTP Preferred Embodiment and is graphically illustrated on $ELTP website.



8,703,186 Patent….Patent Application 13/863,764

This is the 3rd of the Triple Patents and has been awarded to $ELTP based specifically on the manufacturer details for the 50 mg Naltrexone bead and its sequestering polymer to absolutely minimize Naltrexone leakage. The 50 mg Naltrexone bead is premade and can be used with any agonist opioid both type and expected dosage ranging up to 24 HR ER. The Preferred Embodiment supports the 2-bead modular technology outlined in $ELTP’s 8,425,933 Patent where unidentifiable agonist and antagonist beads are mixed together in one capsule.

In addition general broad-brush reference is made to a non-modular single bead technology manufactured with layering the agonist on to the antagonist but no specific manufacturing illustrations are given that can actually be patented. So it remains as a trade-secret or basis for a possible future single bead patent or simply $ELTP keeping its R&D “possibilities” open


Elite’s 2nd Generation ADF Patents and Patent Applications

Patent 9,056,054

http://patft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=9056054.PN.&OS=PN/9056054&RS=PN/9056054

Patent Application 13/379486

http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20120189693.PGNR.&OS=DN/20120189693&RS=DN/20120189693


Patent Application 14/714,552

http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20150250732.PGNR.&OS=DN/20150250732&RS=DN/20150250732