Aurobindo Pharma shares rise 2% on USFDA approval for asthma drug

Shares of Aurobindo Pharma ltd. surged as much as 2.4% to hit intraday high ₹1,046 apiece on the BSE today  after the pharma major’s wholly owned subsidiary company, Eugia Pharma Specialities received approval from USFDA (US Food & Drug Administration) to produce and trade Budesonide Inhalation Suspension. The drug is used for treatment of asthma and as prophylactic therapy in children of age 12 months to 8 years.

The product, which  is expected to be launched in FY25, has an estimated market size of $226.4 million for the twelve months ending September 2023, according to IQVIA, a U.S.-based clinical research services provider.

At 12.33 PM, the stock was trading 1.55% higher at ₹1037.00. In contrast to this, the broader BSE sensex was trading 0.29% or 192.55 lower at 66,709.36. The market capitalisation of Aurobindo Pharma stood at ₹60,820.43 crore.

According to an exchange filing released by the Hyderabad-based company, the U.S. drug regulator has given nod to produce and trade Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampule. The single-dose Ampule is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), PULMICORT RESPULES (budesonide) Inhalation Suspension by Astrazeneca Pharmaceuticals LP.

Budesonide is used to control and prevent symptoms like wheezing and shortness of breath caused by asthma, dosage forms and strengths are available such as: Inhalation suspension of either 0.25 mg/2mL or 0.5 mg/2mL or 1 mg/2mL, as per the release.

This is the 173rd ANDA approval (including 9 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oral and sterile specialty products. Aurobindo now has a total of 500 ANDA approvals (478 Final approvals and 22 tentative approvals) from USFDA. 

Earlier on Wednesday, Aurobindo Pharma received USFDA’s final approval to manufacture and market Darunavir Tablets, 600 mg and 800 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Prezista Tablets, 600 mg and 800 mg, of Janssen Products, L.P. 

The approved product has an estimated market size of $274.8 million for the twelve months ending October 2023, according to IQVIA. 

Darunavir Tablets, 600 mg and 800 mg, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and paediatric patients 3 years of age and older.

Aurobindo Pharma  develops, manufactures, and commercialises a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The brand has over 25 manufacturing and packaging units that have got approval by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. Its strong product portfolio is spread over 7 major therapeutic areas enclosing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a sturdy R&D set-up.