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Vyvanse Generics Roll Out In US As Suppliers Work To Meet Demand

Launches Of Lisdexamfetamine Capsules Confirmed By Hikma And Mallinckrodt

Executive Summary

Hot on the heels of multiple US FDA approvals for rivals to the blockbuster ADHD brand Vyvanse, generics suppliers have confirmed launches – and with drugs in this category currently facing shortages, developers are eyeing significant demand.

Late August’s loss of exclusivity for Vyvanse (lisdexamfetamine) in the US represents one of the most significant off-patent opportunities of 2023, and at least two suppliers are already in the market with their versions of the blockbuster attention-deficit/hyperactivity disorder treatment, amid suggestions that demand will be particularly high given current shortages of ADHD drugs.

Coming immediately after the US Food and Drug Administration approved more than a dozen generic versions of lisdexamfetamine in 10mg, 20mg, 30mg 40mg, 50mg, 60mg and 70mg strengths – as well as a handful of generic lisdexamfetamine chewable tablets in 10mg, 20mg, 30mg 40mg, 50mg and 60mg strengths (see sidebar) – Hikma and Mallinckrodt confirmed that they had launched their generics.

With Hikma confirming on 31 August the US launch of its 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg lisdexamfetamine capsules in the US, the firm’s generics unit president Brian Hoffmann said the company was “pleased to have launched our generic version of Vyvanse today immediately upon receiving FDA approval, providing one of the first generic versions of this important medicine to patients and health care providers in the US.”

“This launch is the latest example of our ability to successfully deliver on our pipeline and launch new products, expanding access to needed medicines for our customers and their patients,” Hoffmann underlined.

In its financial year ended 31 March 2023, originator Takeda reported total sales of Vyvanse – also sold as Elvanse in other territories – of ¥459.3bn ($3.14bn), up two-fifths over the previous financial year.

The vast majority of this turnover came from the US, where Vyvanse generated sales of ¥372.2bn – or around $2.4bn – with this figure up 38.6% from the previous year “mainly due to the growth of the adult market including an impact from a shortage of generic versions of the instant release formulation of Adderall in the US and favorable foreign exchange rates.” (Also see "Sandoz Weighs In On US Adderall Shortages Amid Supply Disruption" - Generics Bulletin, 11 Oct, 2022.)

However, citing IQVIA data, Hikma said that US sales of Vyvanse were “approximately $5.1bn in the 12 months ending 30 June 2023,” suggesting that the opportunity may be even bigger than expected.

“Patients across the US are currently experiencing shortages of ADHD medicines like lisdexamfetamine,” Hoffmann observed. “We are eager to work with the US Drug Enforcement Administration to obtain adequate supplies of raw materials that would enable Hikma to expediently use its strong US-based manufacturing and distribution capabilities to help address shortages of this essential medicine.”

Separately, Mallinckrodt announced its own launch of lisdexamfetamine 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg capsules via its SpecGx generics unit, with management also pointing to the enlarged opportunity that had resulted from recent ADHD drug shortages.

“Lisdexamfetamine dimesylate is included among the ADHD medications currently on the FDA’s drug shortage list, so we are very pleased to be able to launch this product at this time to help address a critical need in the market,” said Stephen Welch, executive vice president and head of specialty generics. “We will be working closely with the DEA to request and secure additional quota to increase our production following this approval because we understand the vital importance of patient access to affordable, high-quality generic ADHD medicines.”

Noting that it had begun “immediate commercialization of the product” upon approval, Mallinckrodt also underlined the local production of its version for the US market, pointing out that that SpecGx’s generic was “manufactured at its plant in Hobart, New York utilizing active pharmaceutical ingredient manufactured at its plant in St. Louis, Missouri.”

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