Lupin has received the Food and Drug Administration’s permission for a new generic, and the company has launched two new generics.
The company has received the FDA's blessing for Propranolol Hydrochloride Extended-Release Capsules, 60 mg, 80 mg, 120 mg, and 160 mg, which is a generic of ANI’s Inderal LA ER Capsules.
The product will be manufactured at Lupin’s Pithampur facility in India.
Propranolol Hydrochloride Extended-Release Capsules, 60 mg, 80 mg, 120 mg, and 160 mg are indicated for:
Hypertension
Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.
[Read more: Lupin receives FDA OK for generic Banzel]
Angina Pectoris Due to Coronary Atherosclerosis
Propranolol Hydrochloride Extended-Release Capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.
Migraine
Propranolol Hydrochloride Extended-Release Capsules are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use.
[Read more: Lupin receives FDA nod for 3 generics]
Hypertrophic Subaortic Stenosis
Propranolol Hydrochloride Extended-Release Capsules improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
Propranolol Hydrochloride Extended-Release Capsules (RLD Inderal LA) had a market value of roughly $71 million, per IQVIA November 2023 data.
Lupin also announced the launch of Varenicline Tablets, 0.5 mg and 1 mg, which is the generic of PF Prism C.V.'s Chantix. It is indicated for use as an aid to smoking cessation treatment.
Varenicline Tablets (RLD Chantix) had a market value of roughly $412 million, per IQVIA November 2023 data.
Lupin also launched Bromfenac Ophthalmic Solution, 0.07%. Lupin is the exclusive first-to-file for this product and is eligible for 180-day exclusivity.
Bromfenac Ophthalmic Solution, 0.07% is the generic of Bausch & Lomb's Prolensa, which is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
Bromfenac Ophthalmic Solution (RLD Prolensa) had a market value of approximately $182 million, per IQVIA November 2023 data.
