Generic Product News: May 2021

Norelgestromin, Ethinyl Estradiol Transdermal System

Manufactured by Amneal Pharmaceuticals

Compare to: Ortho Evra
The FDA recently approved Amneal’s 150 μg/d norelgestromin and 35 μg/d ethinyl estradiol transdermal system, indicated for the prevention of pregnancy in women with a body mass index of less than 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. It may be less effective in women who weigh 198 lbs or more. The product carries a boxed warning regarding cigarette smoking and serious cardiovascular events.

Progesterone Capsules

Manufactured by Insud Pharmaceuticals

Compare to: Prometrium
Insud Pharmaceuticals is expanding its generic drug offerings with generic progesterone capsules in dosage strengths of 100 and 200 mg. The capsules are indicated for use in the prevention of endometrial hyperplasia in postmenopausal women who have not undergone a hysterectomy and who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.

Brinzolamide Ophthalmic Suspension, 1%

Manufactured by Teva Pharmaceuticals

Compare to: Azopt
In the first-to-market generic of Azopt, Teva Pharmaceuticals is debuting brinzolamide ophthalmic suspension, 1%, for the treatment of elevated pressure in the eye due to ocular hypertension or open-angle glaucoma. The suspension works by decreasing the amount of fluid within the eye, providing patients with another treatment option. Brinzolamide ophthalmic suspension 1% has a market value of more than $184 million, according to data from IQVIA in December 2020.

Everolimus Tablets

Manufactured by Breckenridge Pharmaceuticals

Compare to: Afinitor
Breckenridge has received FDA approval for everolimus tablets, a kinase inhibitor indicated for the treatment
of postmenopausal women with advanced hormone receptor–positive HER2-hormone receptor–positive, HER2- negative breast cancer in combination with exemestane after failure of treatment with anastrozole or letrozole. It is also indicated for adults with progressive neuroendocrine tumors of pancreatic origin and adults with progressive, well-differentiated, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin that are locally advanced, metastatic, or unresectable.