Makers of Zoloft (sertraline hydrochloride) and its generic versions are reporting shortages linked to increased demand during the pandemic coupled with supply chain issues caused by the impact of COVID-19 on manufacturers of active pharmaceutical ingredients (APIs).
Accord Healthcare, InvaGen Pharmaceuticals, Lupin and Pfizer, the blockbuster antidepressant’s brand name manufacturer, have all reported to the FDA that they are experiencing difficulties in supplying the product.
The FDA said it is working closely with the drugmakers on increasing their supply to respond to the increased demand. An agency spokesperson noted that there have been previous shortages of antidepressants, but that Zoloft and generic sertraline have not been in shortage in recent years.
Pfizer has noted shortages for two of its Zoloft packages, estimating that one would be resolved this month while the timeline for the other is yet to be determined.
“We are able to supply our historical market share but unable to make up for increased demand,” a Pfizer spokesperson said.
Two other versions of the product that were in shortage — which were not detailed on the FDA’s drug shortages database — are now back in stock, a Pfizer spokesperson said.
For Accord and Lupin, the problems stem from a struggle to obtain the active pharmaceutical ingredient (API) needed to make their generic versions. Citing the impact of COVID-19, Accord said that it is currently unable to support monthly demand for three versions of its generic, including its 500-count 50mg and 100mg versions, because it can’t obtain the API. That shortage is expected to last 60 days.
Similarly, Lupin said it is facing an API shortage and increased demand, leaving it unable to adequately supply 11 versions of its generic. Although it’s engaging in continuous production, the drugmaker said the products will be on back order for a “few months.”
InvaGen, a subsidiary of Cipla, said seven versions of its generic sertraline are on back order, but did not give reasons for the shortages. — James Miessler