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Dr. Reddy 's Laboratories' hopes of resuming sales of its generic version of the Indivior Suboxone in the United States have been reduced to nothing when a court has restricted it in the United States. pending litigation on the patent of the opioid dependence treatment drug
. spotlighting Dr. Reddy's certificate when markets reopen on Monday, the US District Court of New Jersey granted a preliminary injunction against the firm headquartered in Hyderabad.
statement issued by Indivior said with him restrictions of the previous restrictive temporary order (TRO) remain. DRL would be "unable to sell, offer to sell or import its generic sublingual buprenorphine / naloxone film product, pending the outcome of the recently filed DRL litigation related to US Patent No. 9,931,305 or a US Court of Appeals decision for "
Indivior CEO, Shaun Thaxter, said:" As a result of the court's decision, Dr.Reddy's is prevented from reviving its generic product until the 305 patent dispute is concluded or until the DRL overrides an appeal of this injunction. Although we do not know the timing of these events, we will continue to vigorously defend our intellectual property. "
In response to the developments, Dr.Reddy Laboratories said Saturday that" the company disagrees with the court's decision "
The company said that it had been the only company in the world. intends to appeal the US District Court's decision in a hearing regarding the new sales and commercialization of Dr. Reddy's Buprenorphine and Naloxone Sublingual film in the United States. announcing the approval of the USFDA for the generic version Dr.Reddy's had announced that he would introduce the product in the United States with an approved program of risk badessment and evaluation. Mitigation strategy
The Indivior claims that Dr.Reddy's had sold a quantity of his generic sublingual buprenorphine / naloxone film to the US market prior to the granting of TRO on June 15th. " The company does not know the exact amount of product sells u by DRL before the issuance of the TRO, but relying on the recent brutal loss of market share of his film Suboxone, the impact on the net revenue of the 2018 fiscal year should be d & # 39; At least $ 25 million. On July 16, Indivior ordered Indivior to post a bond to ensure the safety of DRL if the court concluded at the end of the patent litigation that the '305 patent is invalid and / or not infringed. The amount of the bond will be determined by the court at a later date
The court ruling does not prevent patients or payers from accessing sublingual generic buprenorphine / naloxone drugs, all currently available treatments not being affected by the decision. The US market for drug treatment is already very competitive with multiple therapies available, more than half of which are generic drugs, said Indivior.
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