Generics

Upsher-Smith, the Maple Grove, Minn.-based subsidiary of Japan’s Sawai Pharmaceuticals, has re-introduced its Klor-Con (potassium chloride for oral solution). The company received approval from the Food and Drug Administration for the product that joins its generics portfolio. The company noted that the relaunched product would be available with a new NDC number.

The product has a U.S. market size of $98 million for the 12 months ended September 2017, according to data from IQVIA.

Perrigo has introduced two products, a generic of Mycolog II Cream (nystatin and triamcinolone acetonide cream, 1 mg/gram) and the Exalgo (hydromorphone HCl) extended-release tablets.

The Dublin, Ireland-based company’s Mycolog II Cream generic is indicated to treat cutaneous candidiasis. The drug had annual generics sales of $81 million for the 12 months ended September 2017, according to IQVIA data.

Ajanta Pharma has launched its generic of Concordia Pharmaceuticals’ Kapvay (clonidine hydrochloride) extended-release tablets. The Mumbai-based company’s launch of the product follows the Food and Drug Administration approving it on Tuesday.

The drug is indicated to treat attention deficit hyperactivity disorder as a monotherapy and as adjunctive treatment to stimulants. Ajanta’s generic will be available in 0.1-mg dosage strength.

The Food and Drug Administration has approved Glenmark Pharmaceuticals’ generic of Allergan’s Hailey Fe 1/20 norethindrone acetate, 1 mg, and ethinyl estradiol, 20 mcg) tablets.

The drug is indicated to prevent pregnancy. It had U.S. brand and generic sales of roughly $116.8 million, according to data from IQVIA for the 12 months ended September 2017.

Glenmark said that its portfolio currently consists of 129 products in the United States, with a further 58 applications pending FDA approval.
 

The Food and Drug Administration has approved Cipla’s generic of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension). The drug is indicated as a maintenance treatment for asthma and as prophylactic therapy in children ages 12 months to 8 years. The Mumbai-based Cipla said the drug was available immediately for shipment.

Cipla’s generic will be available in dosage strengths of 0.25 mg/2 ml, 0.5 mg/2 ml and 1 mg/2ml. The product and its generics had U.S. sales of roughly $825 million for the 12 months ended September 2017, according to IQVIA data.

Despite the challenges that manufacturers have faced from slowing generics spending growth, generics saved the U.S. healthcare system more than ever, and the past year has seen a record number of approvals. It also has seen more biosimilars getting regulatory approval, and the Food and Drug Administration carving out new and speedier paths for companies to enter areas where there is a market need for the products.

It’s been an interesting year for the generics industry. While the volume of dispensed prescriptions rose, the Food and Drug Administration, under a new commissioner, has taken several steps that certainly will impact the industry in the short and long terms. Drug Store News sat down with Chester “Chip” Davis, president and CEO of the Association for Accessible Medicines, to discuss how the generics industry is adapting to a changing market, and new opportunities manufacturers may be looking to pursue.

Patent expirations on branded drugs are the generics industry’s bread and butter — and the years to come hold a lot of promise. QuintilesIMS projects that by 2021, the loss of patent protection is set to reduce spending on branded drugs by $140 billion from current levels. The potential impact is markedly larger than the $93.6 billion that loss of patent protection cost branded medicine companies between 2012 and 2016.