Ipratropium Bromide

Mumbai: The United States Food and Drug Administration (U.S. FDA) has approved Lupin Limited ’s Abbreviated New Drug Application (ANDA) for Ipratropium Bromide Nasal Solution (Nasal Spray), 0.06 per cent. The approval allows the company to market a generic version of Atrovent Nasal Spray , 0.06 per cent, manufactured by Boehringer Ingelheim Pharmaceuticals, Inc. It will be produced at Lupin’s facility in Pithampur, India. Ipratropium Bromide Nasal Solution (Nasal Spray), 0.06 per cent is indicated for symptomatic relief of rhinorrhea (runny nose) associated with the common cold or seasonal allergic rhinitis for adults and children aged 5 years and older. According to IQVIA MAT data from November 2024, the reference drug (RLD Atrovent) had estimated annual sales of approximately USD 42 million in the U.S. By Online Bureau ,

Bayer’s Nexavar and Boehringer Ingelheim’s Spiriva are among a handful of drugs with reduced US list prices for the new year, according to a Tuesday analysis that showed average prices growing at their slowest rate in years. Bayer cut the list price of its cancer drug Nexavar in half, effective Jan. 1, according to data compiled by Drug Channels Institute (DCI). The list prices for Merck’s diabetes drugs Janumet XR and Januvia were cut by 42.4%. And Boehringer reduced the list price of its asthma drug Spiriva by 36.7% and Atrovent, which is used to treat chronic obstructive pulmonary disease, by 35.0%. On average, list prices last year for brand-name drugs grew at their lowest rate in a decade, according to the analysis. In 2024, they were up 2.3%, compared with 5% between 2019 and 2024, according to Drug Channels. Most patients don’t pay list prices, which are used as a starting point for negotiations with insurers, who typically pay a far lower net price, pocketing some of the difference in the form of rebates that can be used as incentives to prefer one drug over another. Those rebates have become an increasingly powerful force in price negotiations over the years, though they have also caused significant scrutiny of the insurance and pharmacy benefit management industry. And as list prices have risen, the handful of patients who buy drugs without insurance, or who pay a percentage of the list price, have faced financial pain from that dynamic. The shift to reduced list prices may partly be drugmakers’ reaction to the Inflation Reduction Act, which for the first time allows the federal government to directly negotiate drug prices with manufacturers. The law targets drugs with high Medicare spending based on list costs. That could “encourage manufacturers to narrow large gross-to-net gaps so as to bypass a drug’s selection by CMS,” DCI president Adam Fein said in his analysis. But Fein told Endpoints News Tuesday that the IRA won’t necessarily reduce the gross-to-net price gap for drugs not part of the negotiation process. He said that the law will still “encourage Part D plans to prefer high-list, high-rebate specialty drugs, even as the government and manufacturers will prefer a low list-price version.” A Merck spokesperson said the company lowered the list prices of its diabetes drugs to “align the list price more closely to the net price.” The price decrease is “unrelated” to the Medicare drug price negotiation process, the spokesperson said. Januvia was included in a list of drugs to face negotiations last year. The Centers for Medicare & Medicaid Services is slated to announce the second round of drugs selected for negotiation by Feb. 1. A Boehringer spokesperson said list price reductions are part of its “normal business practices” and that its action reflects the company’s “ongoing commitment to patient affordability and access.” A representative for Bayer didn’t immediately respond to a request for comment. Bayer’s and Boehringer’s drugs were not included in last year’s IRA list. Editor’s note: Updates article with comment from Boehringer.