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Vyvanse Generics Get Green Light To Enter US

More Than A Dozen Firms Receive FDA Approvals For Lisdexamfetamine Rivals

Executive Summary

One of 2023’s most significant loss-of-exclusivity opportunities for the generics industry has come to pass, after the US FDA approved more than a dozen rivals to Takeda’s blockbuster ADHD treatment Vyvanse.

One of this year’s biggest loss-of-exclusivity opportunities for the US off-patent industry has come to pass, after the US Food and Drug Administration approved more than a dozen generic rivals to Takeda’s blockbuster attention-deficit/hyperactivity disorder treatment Vyvanse (lisdexamfetamine).

Generic versions of lisdexamfetamine capsules in 10mg, 20mg, 30mg 40mg, 50mg, 60mg and 70mg strengths have been approved by the FDA for a large group of firms including Teva’s Actavis, Alkem, Amneal, Apotex, Ascent, Hikma and Lannett, as well as Viatris’s Mylan, Norwich, Prinston, Rhodes, Mallinckrodt’s SpecGX and Sun Pharma.

Meanwhile, chewable generic lisdexamfetamine tablets in 10mg, 20mg, 30mg 40mg, 50mg and 60mg strengths have been approved for Ascent, Sun and Teva.

“Many abbreviated new drug applications for lisdexamfetamine dimesylate received priority review,” the FDA commented as it announced the approvals. Launch plans were not immediately disclosed by the generics firms.

In its financial year ended 31 March 2023, 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, the Japanese originator has indicated that it expects Vyvanse sales to drop by around two-fifths to ¥283.0bn this fiscal year in the face of US competition.

This – along with a loss of exclusivity for Azilva (azilsartan) for hypertension in Japan earlier this year in June – is expected to put a significant dent in Takeda’s results this year, although continued growth for the company’s portfolio of Growth & Launch Products this fiscal year should “largely” offset the impact (see sidebar).

Announcing the generic approvals, the FDA noted that prescribing information for lisdexamfetamine dimesylate capsules and chewable tablets contains a boxed warning to inform health care providers and patients about the potential risk of abuse and dependence.

Follows Legal Battles With Generic Challengers

Vyvanse’s loss of exclusivity comes as a long list of patents, all of which included six months of pediatric exclusivity, expired towards the end of August, removing the final barrier for generics to enter the market.

However, some players had attempted to gain a head start in the market by challenging intellectual property protecting the ADHD brand.

Earlier this year, the US Court of Appeals for the Federal Circuit blocked abbreviated new drug application sponsor Norwich Pharmaceuticals from launching early, affirming without comment an unfavorable lower court patent-infringement ruling from late 2022 (see sidebar).

Other firms, including those now holding ANDA approvals, had previously been party to patent infringement litigation heard in the middle of the 2010s, in which they too tried and failed to find a way around Vyvanse’s school of patents.

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