Pharma major Strides Shasun said it has decided to launch the ‘over the counter’ version of ulcer drug Ranitidine in 150 mg dosage in the US markets immediately.
Strides Shasun is already a key player in the US Ranitidine market with 32% market share through its prescription version in 150 mg and 300 mg doses.
OTC drugs are those that can be purchased without a doctor’s prescription, unlike Rx or prescription drugs. In many cases, lower doses of a drug are classified by the regulator as OTC, while higher dosages are Rx.
Strides Shasun said the new OTC launch will further strengthen company’s Ranitidine franchise.
Ranitidine belongs to a class of drugs known as H2 histamine blockers. It is used to treat peptic ulcers of the stomach and intestines and gastroesophageal reflux and heartburn related to indigestion.
According to IRI data, the US OTC market for Ranitidine Tablets, which is the generic form of the popular brand Zantac, is approximately USD 200 million.
This is also the first product approval from company’s 50:50 JV with Vivimed Labs.
The product will be backward integrated and will be manufactured at the JV’s Oral dosage facility in Chennai.
Strides will have exclusive marketing rights for the product in the US.
Strides Shasun has 82 cumulative ANDA (generic drug application) filings with US Food and Drug Administration, including those under its JV with Vivimed.
Out of these, 50 ANDAs have been approved as of date and 32 are pending approval.