Lannett Company, Inc. today announced the launch of Cediprof, Inc.'s FDA approved Levothyroxine Sodium Tablets USP, under the companies' recently announced interim exclusive supply and distribution agreement.

The companies also said they have prevailed in separate legal challenges by Cediprof's previous distributor of the product. Judges in two courts denied a request by the previous distribution partner for a temporary restraining order that sought to enjoin Cediprof from terminating the prior agreement and transferring distribution rights to Lannett.

Lannett said the rulings removed a potential hurdle for it to commence distributing the product in the U.S., notwithstanding any ongoing dispute with Cediprof's prior partner on the earlier termination.Cediprof, Inc. is a part of the Neolpharma Pharmaceutical Group family of companies.

The company also recently announced that it will soon launch Levorphanol Tablets 2 mg, a partnered product.

Lannett entered into an exclusive U.S. distribution agreement for Levorphanol Tablets with Novitium Pharma, a U.S. based pharmaceutical company. Under the agreement, Lannett will primarily provide sales, marketing and distribution support for the product, for which it will receive a share of the profits. Other financial terms were not disclosed.

"We are pleased to establish a new strategic relationship with Novitium Pharma, a private company with a growing portfolio of commercial products," said Tim Crew, chief executive officer of Lannett. "Novitium received FDA approval earlier this month of its Abbreviated New Drug Application (ANDA) for Levorphanol Tablets 2 mg, a product currently with a small number of competitors. Levorphanol Tablets 2 mg is a solid addition to our product offering."

Total U.S. sales for the 12 months ended May 2020 of Levorphanol Tablets 2 mg were approximately $60.9 million, according to IQVIA, although actual generic market values are expected to be lower.

Levorphanol Tablets 2 mg is the therapeutic equivalent to the reference listed drug, Levorphanol Tartrate Tablets 2 mg of Sentynl Therapeutics, Inc.

Levorphanol Tablets are included in the Opioid Analgesic Risk Evaluation and Mitigation Strategies (REMS) program. The FDA has determined that a REMS is necessary for all opioid analgesics intended for outpatient use to ensure that the benefits of these drugs continue to outweigh the risks. The Opioid Analgesic REMS is one strategy among multiple national and state efforts to reduce the risk of abuse, misuse, addiction, overdose and deaths due to prescription opioid analgesics.

Neolpharma Pharmaceutical Group engages in the research, development, production and distribution of generic medicines in the following therapeutic areas: CNS, oncology, metabolic disease, rheumatology and infectious diseases. Based in Mexico City, Mexico, Neolpharma Group has affiliates and operations in Puerto Rico, the U.S. and Latin America. 

Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications.