Tamiflu generics in short supply in latest chapter of biopharma's shortage saga

Drug shortages have become par for the course in the waning months of 2022, first plaguing the popular ADHD medicine Adderall, then the common antibiotic amoxicillin. Now, generics of Roche’s influenza stalwart Tamiflu (oseltamivir) are in short supply.  

Teva, Zydus, Macleods, Camber and Amneal are struggling to supply a range of copycat Tamiflu doses in both capsule and powder suspension formats, the American Society of Health-System Pharmacists (ASHP) reported in early December.

Roche’s Genentech has brand-name Tamiflu and Xofluza on tap, the company said in a statement on its website. 

Genentech says it has "sufficient supply to meet the demand," adding that it's "continuously evaluating the need to increase production." The company noted that ahead of the flu season, it's been shipping Xofluza to distributors across the U.S. since September and has been shipping branded Tamiflu since October. 

Generic makers Ajanta, Alembic and Alvogen still have Tamiflu doses available, too, ASHP noted.

Meanwhile, the affected drugmakers “did not provide a reason for the shortage,” according to ASHP’s drug shortage database.

As for the restocking forecast, ASHP noted Amneal had three generic capsule doses on back order and “cannot estimate a release date.”

In an emailed statement, Amneal noted it's "currently at record levels of production," adding that "[o]ver the last several months, we have been manufacturing the product 24/7 in both the U.S. and India."

"This is a seasonal item dependent on forecasts and advance purchases by customers," the company explained.

Teva, for its part, has Tamiflu powder for suspension on back order and estimates supplies will even out in “late” December 2022.

The timing of the shortage is less than ideal, with the Centers for Disease Control and Prevention reporting more than 23,000 influenza hospitalizations as of the week ending Dec. 10, 2023.

The Tamiflu drought marks the latest in a string of drug shortages this year, which have affected everything from Type 2 diabetes meds like Novo Nordisk’s Ozempic and Eli Lilly’s Trulicity to the decades-old chemotherapy fludarabine.

And shortages aren’t going away anytime soon, Bindiya Vakil, CEO of supply chain specialist Resilinc, recently told Fierce Pharma.

Aside from high-profile drug shortages of Adderall and amoxicillin, Vakil flagged another recent warning from the FDA, which has disclosed shortages of more than a dozen drug ingredients—two of which are included in Adderall.

Others include bacteriostatic saline, which is necessary for diluting drugs for IV injections, and compounds used in common drugs for anesthesia, water retention and calcium deficiencies.

Much of the problem comes from U.S. pharmaceutical supply chains’ overdependence on China and India, Vakil pointed out, adding that “[w]e don’t have independence in our drug supply at all.”

Editor's note: This story has been updated with a statement from Amneal. This story was updated again on 12/26/2022 at 7:45 a.m. ET with a statement from Genentech.