Last year was a record-breaking year for generic drug approvals in the United States. The US Food and Drug Administration (FDA) approved 1,027 generic drugs, 843 of which were full approvals, with tentative approvals making up the remainder. Tentative approvals are generic drugs considered ready for market from a scientific perspective, but which cannot gain full approval due to patents or exclusivities on the brand-name drugs.
Furthermore, the agency granted 80 first-time generic drug approvals (approval for the first generic version of a brand name drug. Among the notable 2017 additions to the list of generic medications available in the United States were Strattera (atomoxetine), Coreg CR (carvedilol phosphate), Truvada (emtricitabine and tenofovir), and Vytorin (ezetimibe and simvastatin).
Development and approval of generic drugs are vital for keeping the cost of medication low for the consumer. Branded drugs represent only 11 percent of prescriptions filled in the United States, yet these drugs account for nearly three-quarters of the country’s total drug costs, according to figures from QuintilesIMS.
According to the 2017 Generic Drug Access and Savings in the US Report from the Association for Accessible Medicines (AAM), 87 percent of patients who switch from a branded drug to a generic will save money, with more than half realizing a saving of more than $50.
First-Time Generic Drug FDA Approvals in 2018:
The FDA has granted first-time generic approval to five medications so far this year, including two generic versions of the HIV medication Viread (tenofovir disoproxil fumarate), one from Teva Pharmaceuticals, the other from Aurobindo Pharma Limited. Other first-time approvals this year were:
Xyzal (levocetirizine dihydrochloride tablets) Allergy 24HR
Generic version: Levocetirizine Dihydrochloride Tablets USP, 5 mg
Manufacturer: Dr. Reddy’s Laboratories Ltd.
Use: For temporary relief of these symptoms due to hay fever or other respiratory allergies: runny nose; itchy, watery eyes; sneezing; itching of the nose or throat
Generic version: Remifentanil Hydrochloride for Injection, 1 mg/vial, 2 mg/vial, and 5 mg/vial
Manufacturer: Fresenius Kabi USA, LLC
Use: For intravenous administration as: an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures; for continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting; as an analgesic component of monitored anesthesia care in adult patients.
K-Tab (potassium chloride extended-release tablets)
Generic version: Potassium Chloride Extended-Release Tablets USP, 10 MEQ (750 mg), 20 MEQ (1500 mg)
Manufacturer: Paddock LLC
Use: Treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic periodic paralysis; for the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop (digitalized patients or patients with significant cardiac arrhythmias
Generics soon to launch in the United States
Many new generic medications are set to appear in US pharmacies in the coming months.
Soldyn (minocycline hcl)
Teva Pharmaceuticals, one of the largest manufacturers of generic medication, recently announced the exclusive launch of two strengths (65mg and 115mg) of a generic version of Soldyn (minocycline Hcl) a tetracycline antibiotic used to treat non-nodular moderate to severe acne vulgaris in patients over the age of 12.
Axiron (testosterone topical)
Another notable generic drug to gain FDA approval in recent weeks is a generic version of Eli Lilly and Company’s testosterone topical solution Axiron. Approval for Lupin Pharmaceutical’s Testosterone Topical Solution 30mg per actuation was granted in October 2017 but last week (February 25th, 2018) the company announced the launch of the medication in the United States.
If you are struggling with the price of your medication, speak to your healthcare provider or physician about switching from branded medication to a cheaper generic version of the drug. In 2016, nearly 3.9 billion generic prescriptions were dispensed, amounting to savings of around $253 billion, according to figures from AAM.
Follow the RxSpark blog for regular updates on new generic drug options and other FDA approval news.