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PHARMACY

Elite, Glenmark launch generic methadone tablets

BY Sandra Levy

Elite Pharmaceuticals, a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today announced the commercial launch of generic methadone hydrochloride 5-mg and 10-mg tablets by Glenmark Pharmaceuticals, Elite’s marketing alliance partner.

Methadone is indicated for the management of pain severe enough to require daily, around-the-clock long-term opioid treatment and for which alternative treatment options are inadequate. Methadone also can be used for detoxification treatment of opioid addiction — heroin or other morphine-like drugs — or maintenance treatment of opioid addiction in conjunction with appropriate social and medical services.

Glenmark will sell and distribute certain of Elite’s generic products, including methadone, for which Elite will receive manufacturing and license fees.

There are currently four Elite products that Glenmark will sell. The equivalent brand and generic products have a market value of approximately $34 million, according to IQVIA data.

The launch of the additional products is expected to follow shortly.

“We are excited to begin our Glenmark Pharmaceuticals alliance with the launch of our newly approved generic methadone,” Elite president and CEO Nasrat Hakim said.

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PHARMACY

Lupin receives FDA green light for generic Hectorol

BY Sandra Levy

Lupin has garnered the Food and Drug Administration’s clearance for doxercalciferol injection,in 4 mcg/2 mL (2 mcg/mL) multi-dose vials.

The product, which is a generic version of Sanofi Genzyme’s Hectorol injection is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

Doxercalciferol injection had a market value of approximately $133 million, according to September 2018 IQVIA data.

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Lannett to market 2 generics

BY Sandra Levy

Lannett announced that it has expanded its agreement with Sunshine Lake, the U.S. subsidiary of the HEC Pharm Group of China, to be the exclusive distributor in the U.S. of a generic of AbbVie’s Biaxin XL (clarithromycin) extended-release tablets 500 mg and Novartis’ Comtan (entacapone) immediate-release tablets 200 mg. The products have previously been approved by the Food and Drug Administration.

Lannett has commenced marketing clarithromycin and expects to market entacapone in early calendar year 2019. Financial terms were not disclosed.

“We continue to add market-ready products to our offering, including clarithromycin, where there are few suppliers,” said Lannett CEO Tim Crew. “HEC is an important strategic alliance partner, and we are thrilled to expand our agreement to now include clarithromycin and entacapone. These products advance our near-term objective of increasing our revenues, further strengthening our business.”

Clarithromycin ER tablets 500 mg and entacapone IR tablets 200 mg have a market value of about $8 million and $24 million respectively for the 12 months ended September 2018, according to IQVIA data, though the company said generic market values are expected to be lower.

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