Ruling revives launch of Dr. Reddy’s generic Suboxone sublingual film
Dr. Reddy’s will resume its launch of generic Suboxone sublingual film, an opioid treatment drug, following a ruling by the United States Court of Appeals for the Federal Circuit in favor of the company.
The ruling concluded that Indivior had not shown that it is likely to succeed on the merits of its infringement case on U.S. Patent No. 9,931,305.
This decision vacates the District Court’s preliminary injunction that had prohibited Dr. Reddy’s from selling its generic version of Suboxone (buprenorphine and naloxone) sublingual film.
“We are pleased with the decision of the appellate court in Dr. Reddy’s favor, vacating the preliminary injunction that had prevented Dr. Reddy’s from bringing this important drug to the public. We are committed to providing affordable and innovative medicines that address the unmet and under-met needs of patients around the world and, in particular, look forward to taking the lead in helping to fight opioid use disorder,” a company spokesperson said.
In June, the FDA approved Dr. Reddy’s buprenorphine and naloxone sublingual film in four strengths, including 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg. The product was launched immediately after approval, with sales and commercialization activities halted as a result of a court imposed temporary restraining order, or TRO, against Dr. Reddy’s.
The TRO did not include a prohibition on commercial manufacturing of the product.
Lupin gets FDA nod for 2 generics
Lupin has received the Food and Drug Administration’s blessing for clomipramine hydrochloride capsules in 25-, 50- and 75-mg dosage strengths. The product is a generic version of SpecGx’ s Anafranil capsules.
It is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder
Anafranil capsules, 25 mg, 50 mg, and 75 mg had a market value of approximately $109.6 million, according to IQVIA September 2018 data.
The FDA also approved Lupin’s potassium chloride for oral solution, 20 mEq.
The product, which is a generic version of Pharma Research Software Solution’s potassium chloride for oral solution, 20 mEq, is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.
The product had a market value of approximately $105 million, according to September 2018 IQVIA data.
Perrigo gets tentative FDA approval for generic Ultravate lotion
Perrigo has received tentative approval from the Food and Drug Administration for the first to file generic version of Ultravate lotion (halobetasol propionate) 0.05%.
Perrigo previously announced a patent litigation suit with Sun Pharmaceutical Industries and MiCal Pharmaceutical for this product.
Ultravate lotion 0.05% is indicated for the topical treatment of plaque psoriasis in patients age 18 years old and older.
The product had a market value of about $17 million for the 12 months ending September 2018, according to IQVIA.
“Our R&D team continues its efforts to secure regulatory approvals for important new products. This tentative approval reflects our continued dedication to developing extended topical products for patients and further illustrates our commitment to advancing our new product pipeline,” Perrigo executive vice president and president of Rx pharmaceuticals Sharon Kochan said.