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Hikma Has A Trio Of US Launches

Rival To Banzel Tablets Joined By Injectable Ganciclovir And Doxycycline

Executive Summary

Hikma has added three products – a generic version of Banzel tablets and injectables ganciclovir and doxycycline – to its US portfolio.

Hikma has launched a trio of new products in the US, including a generic version of Banzel (rufinamide) tablets in 200mg and 400mg strengths, as well as injectables ganciclovir and doxycycline.

Announcing the rufinamide launch, Hikma Generics president Brian Hoffmann said the company was “proud to be among the first wave of generics to provide this important medicine,” insisting that “this launch demonstrates our ability to successfully deliver on our pipeline and launch new products, improving patients’ access to high-quality generic medicines.”

Citing IQVIA data, Hikma said the treatment for seizures associated with Lennox-Gastaut syndrome in pediatric patients 1 year of age and older and in adults had sales of around $285m in the 12 months ended April 2021.

Alongside Hikma, three other firms – Glenmark, Hetero and Viatris’ Mylan – also hold US Food and Drug Administration approvals for generic versions of Banzel 200mg and 400mg tablets.

“Hikma also markets rufinamide oral suspension and we are pleased to add this new formulation to our portfolio,” Hoffmann commented. The firm had announced last November the launched of a generic version of Banzel 40mg/ml oral suspension in the US, citing annual sales of around $125m for this presentation.  (Also see "Hikma Offers Update On Plans For Advair Rival" - Generics Bulletin, 6 Nov, 2020.) Alkem, Bionpharma and Lupin also hold approvals for generic versions of the oral suspension.

Meanwhile, Hikma said its launch of its 500mg ganciclovir for injection would allow it to enter a US market worth around $8m annually for the cytomegalovirus retinitis treatment. And the launch of 100mg doxycycline for injection would see the antibiotic compete in a US market that was worth around $43m annually.

The launches add to a 2021 slate that has already seen Hikma introduce injectables dexmedetomidine and docetaxel (Also see "Hikma Introduces A Pair Of US Injectables" - Generics Bulletin, 10 May, 2021.), as well as more recently the first generic labetalol hydrochloride injection in ready-to-use bags along with injectable hydralazine and estradiol valerate. (Also see "Hikma Has A First With Labetalol Launch In US" - Generics Bulletin, 2 Jun, 2021.)

Hikma also reintroduced its generic version of Advair (fluticasone/salmeterol) to the US market in April, while at the same time trailing the launch later this year of its recently-approved Kloxxado (naloxone) 8mg nasal spray. (Also see "Advair Relaunch And Nasal Naloxone Nod Raise Hikma’s Expectations" - Generics Bulletin, 30 Apr, 2021.)

Patrick Genestin, newly-appointed vice-president of business development for Hikma Generics, recently told Generics Bulletin that the company was aiming to continue to accelerate its pipeline and launch schedule as part of efforts to maintain growth for the segment in the US, in an exclusive interview (see sidebar).

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