In its generics guidance for 2022, Hikma shared Jazz Pharmaceuticals’ update to its expectations for the launch timing of an authorized generic of Xyrem (sodium oxybate) as provided in its first-quarter 2022 earnings conference call.
Xyrem is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness in patients aged 7 years old and older with narcolepsy.
Jazz now expects authorized generic entry to occur in late 2022, or possibly even January 2023, Hikma said.
In 2017, the company entered into a settlement agreement with Jazz to sell an authorized generic of Xyrem. Under the terms of this agreement, Hikma has a certain launch date of Jan. 1, 2023 or earlier depending on certain market conditions, and 180 days of exclusivity.
To align with Jazz’s updated expectations, Hikma now conservatively assumes it will launch its authorized generic on Jan. 1, 2023, and that the revenue and profit contribution from the exclusivity period will shift to the first half of 2023.
Reflecting this, the company updated its guidance for its generics business. For 2022, Hikma now expects generics revenue to be in the range of $710 million to $750 million and core operating margin to be around 20%, with the lower end of the range reflecting the possibility of further price erosion in the U.S. generic market, should this materialize. This compares with Hikma’s previous guidance of generics revenue growth in the range of 8% to 10% over full-year 2021 revenue of $820 million and core operating margin in the range of 24% to 25%.
All other guidance remains unchanged, the company said.
The Food and Drug Administration has given Lupin permission for two new generics.
The FDA approved Iloperidone tablets, a generic of Vanda’s Fanapt tablets, in dosage strengths of 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg.
Fanapt is used for the treatment of schizophrenia in adults and will be manufactured at Lupin's facility in Goa, India.
Iloperidone tablets had a market value of roughly $162 million, according to March 2022 IQVIA data.
Lupin also received the FDA’s clearance for pregabalin capsules in dosage strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg.
The medication is the generic of Upjohn’s Lyrica, which is indicated to treat fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in adult patients, as well as partial-onset seizures in patients aged 1 month old and older with epilepsy who take one or more other drugs for seizures.
The product will be manufactured at Lupin's facility in Aurangabad, India.
Pregabalin capsules had a market value of approximately $263 million, according to IQVIA March 2022 data.
One Brands has a brand-new limited-edition protein bar variety that was inspired by a classic ice cream flavor.
The Boulder, Colo.-based company’s new rocky road-flavored bars contain a chocolatey center filled with almonds and marshmallow-flavored bits surrounded by a decadent icing-like coating, according to the brand.
“Summer and ice cream go hand in hand, and One is making it easy to enjoy the delicious flavor of rocky road in a convenient bar that includes 20 g of protein and only 1 g of sugar,” said Eric Clawson, One general manager. “One Brands is known for flavor innovation, and our proprietary blends not only capture the best flavors from cinnamon roll to chocolate brownie, but our soft, not chalky, bar texture is the reason to believe you can really have your sweets and protein too.”
Available for a limited time, One Brands’ rocky road bar can be found online at one1brands.com and Amazon.com, as well as in stores at The Vitamin Shoppe and Circle K among others.
Xiromed, the New Jersey-based generic division of Insud Pharmaceuticals — a global pharmaceutical group headquartered in Madrid, Spain — is offering progesterone injection 500 mg/10 ml (50 mg/ml) in a multiple-dose vial.
The medication is the generic of progesterone injection, which is used to restore normal menstrual periods (amenorrhea) or treat abnormal bleeding due to low hormone levels.
Progesterone injection 50 mg/ml and its generics had a market value of $20.4 million for the 12-month period ending February 2022, according to IQVIA.
“This is Xiromed’s second U.S. product launch from our dedicated hormonal injectable facility, Laboratorios Farmalan, located in Leon, Spain,” said Donna Genova, senior vice president of sales and commercial operations. “Xiromed continues to execute on our strategy to bring a robust portfolio of hormonal injectable products to the U.S. market.”
Kellogg’s Frosted Flakes celebrates ‘Obi-Wan Kenobi’ premiere with limited-edition cereal
Just weeks before the premiere of the “Obi-Wan Kenobi” series on Disney+, Kellogg’s Frosted Flakes joined forces with Lucasfilm on the launch of a new limited-edition cereal.
The new Kellogg’s Frosted Flakes Obi-Wan Kenobi cereal reflects the series’ dark and light side with a combination of the brand’s chocolate and classic flavors.
“For decades, ‘Star Wars’ has united fans across generations for movie nights, and we look forward to doing the same at the breakfast table with the release of our new Kellogg’s Frosted Flakes Obi-Wan Kenobi cereal,” said Sadie Garcia, director of brand marketing at Kellogg All Family Cereal.
In addition, the packaging even features Tony the Tiger sporting his best Obi-Wan Kenobi and Darth Vader attire in honor of the upcoming series, which premieres on May 27 on the streaming platform.
Kellogg’s Frosted Flakes Obi-Wan Kenobi cereal will be available at retailers nationwide beginning in July at the suggested retail price of $4.29 for a 10.7-oz. box and $5.29 for a 17.1-oz. box.