Generics

DUBLIN — The United States is the biggest generic drugs market in the world, with nearly 80% of prescriptions in American written for generics, according to Research and Markets’ “Analyzing the Generic Drugs Sector of the U.S. Pharmaceutical Industry 2017.”

MUMBAI, India — The U.S. Food and Drug Administration gave final approval for Lupin’s Tobramycin Inhalation Solution USP, 300 mg/5 ml, a generic version of Novartis Pharmaceuticals’ TOBI 300 mg/5 ml.

Lupin’s Tobramycin Inhalation Solution USP, 300 mg/5 ml is the AN rated generic equivalent of Novartis Pharmaceuticals’ TOBI 300 mg/5 ml. It is indicated for the management of cystic fibrosis patients with P. aeruginosa.

Tobramycin Inhalation Solution USP, 300 mg/5 ml had U.S. sales of $133.6 million (IMS MAT December 2016).

MAPLE GROVE, Minn. — Upsher-Smith Laboratories on Wednesday launched Clomipramine Hydrochloride Capsules USP, 25 mg, 50 mg and 75 mg, the generic equivalent to Mallinckrodt Pharmaceuticals’ Anafranil (clomipramine hydrochloride) Capsules USP in the United States.

The clomipramine hydrochloride capsules market had U.S. sales of approximately $172 million for the 12 months ending December 2016, according to IMS Health.

BATON ROUGE, La. — OncBioMune Pharmaceuticals signed a non-binding term sheet with Teva Pharmaceuticals to acquire norepinefrine in Mexico. This agreement can also extend to other Latin American countries.

JERUSALEM — Teva Pharmaceutical Industries on Monday launched an authorized Generic of Minastrin 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) 1 mg/20 mcg in the United States.

The authorized generic is an estrogen/progestin combined oral contraceptive indicated for use by women to prevent pregnancy.

Minastrin 24 Fe, manufactured by Allergan had annual sales of approximately $361 million in the U.S. according to IMS data as of December 2016.
 

MAPLE GROVE, Minn. — Upsher-Smith Laboratories entered into an exclusive agreement with an emerging pharmaceutical company to market and distribute three generic products. These products will compete in markets with combined U.S. annual sales of nearly $200 million, according to IMS Health.

BRIDGEWATER, N.J. — Alembic Pharmaceuticals launched its generic of Sporanox (itraconazole) capsules. The drug is an antifungal used to treat certain fungal or yeast infections.

Alembic will offer the drug in a 100-mg dosage strength. This marks Alembic’s 28th product launch in the United States since its commencement of U.S. operations.