Meitheal Prepares For Major US Injectables Push

Plans To Launch ‘Up To 20 New Products’ In 2024 Following Bupivacaine Introduction

Meitheal Pharmaceuticals says it is preparing to launch “up to 20 new products” this year in the US following a recent expansion of its generic injectables portfolio.

Vials of drugs with syringes

Meitheal Pharmaceuticals says a recent deal to expand its generic injectables portfolio will allow the firm to launch “up to 20 new products” this year in the US “to support a sustainable US drug supply.” The firm intends to build on its recent launch of multiple presentations of bupivacaine hydrochloride injection to supply further products that have recently experienced shortages.

In October 2023, Meitheal announced that it had expanded its generic injectables portfolio through an asset purchase agreement for a “broad portfolio of generic injectables” by parent company, Hong Kong King-Friend Industry Co., known as HKF. The agreement increased Meitheal’s total generic injectables portfolio to 82 products.

Tom Shea, CEO of Meitheal, called the deal a “significant milestone” for the firm’s portfolio that “reinforces our commitment to simplifying access to life-changing medicines through global partnerships.”

Under the agreement, HKF will acquire “the right, title and interest, to 18 additional generic injectable products within the US,” with HKF responsible for development and manufacturing and Meitheal gaining exclusive US commercialization rights.

And now, Meitheal says it is “preparing to launch up to 20 new products in 2024 to support a sustainable US drug supply,” building on its recent launch of bupivacaine.

“Meitheal is pleased to further expand our portfolio of sustainably manufactured and priced generic injectables as we bring additional presentations of bupivacaine hydrochloride injection to market during this time of product shortage,” said Shea. “As we prepare to launch multiple new products in 2024, we are intently focused on expediting delivery of medicines in short supply.”

“With over $100m invested in generic R&D over the past six years,” Shea underlined, “Meitheal is fully committed to pursuing efficient drug development and commercialization to simplify access to life-changing medicines for all patients.” (Also see "Meitheal Reveals Manufacturing Expansion Plans" - Generics Bulletin, 13 February, 2020.)

China’s Nanjing King-Friend Takes Control Of US Injectables Specialist Meitheal
China’s Nanjing King-Friend Biochemical Pharmaceutical has taken a majority stake in US generic injectables specialist Meitheal Pharmaceuticals.
Discover the full story

A capital investment of over $100m by Meitheal’s parent company Nanjing King Friend Biochemical Pharmaceutical (see sidebar), saw the completion of “a brand new, state-of-the-art manufacturing workshop” in 2023.

This was inspected by the US Food and Drug Administration in November of 2023, resulting in the approval of five new lines.

“These approved lines add over 200 million units of capacity for vial and cartridge products that support current and future demand for generic injectables,” Meitheal noted. “These lines are expected to produce commercial products that will have an impact on drug shortages beginning in the second half of 2024.”

“Meitheal is planning for the launch of multiple new products in 2024 across its core therapeutic areas of anti-infectives, anesthetics, critical care, fertility, and oncology by continuously evaluating new product opportunities and prioritizing those that address gaps in the current marketplace.”

As well as generic injectables, Meitheal is also active in biosimilars. The firm last year obtained rights to insulin aspart, insulin lispro, and insulin glargine, via Nanjing King-Friend. (Also see "Meitheal Looks To Chinese Parent To Bring In Three US Insulin Biosimilars" - Generics Bulletin, 10 October, 2023.) And towards the end of the year, the firm announced that it was joining the US Biosimilars Forum industry association. (Also see "Amneal And Meitheal Join Biosimilars Forum" - Generics Bulletin, 19 October, 2023.)

More from Products

Tetris Deal Falls Into Place For UK’s Aspire

 
• By 

Niche generics company Aspire Pharma has struck a deal to acquire a portfolio of products from fellow UK firm Tetris Pharma as it is wound up, paying Tetris parent Arecor £0.5m for UK distribution rights and inventory.

Apotex Extends Formosa Ophthalmic Alliance Into Mexico

 
• By 

Apotex has expanded an alliance formed with Formosa in August for its novel clobetasol propionate ophthalmic treatment, adding Mexican rights to its existing deal for the Canadian market.

Fresenius Kabi Lauds Tocilizumab Momentum As ‘Intense’ Transfer To mAbxience Continues

 
• By 

Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.

US FDA Expands Surprise Foreign Inspections

 
• By 

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

More from Generics Bulletin

After Jazz, Hikma Agrees $50m Settlement For ‘Most’ Xyrem ‘Pay-For-Delay’ Claims

 
• By 

Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”

CIOMS Welcomes Draft Report Feedback On The Inevitable Future Of AI In Pharmacovigilance

 

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

Viatris Pens Aprepitant Settlement Agreement After Kabi Loses Initial Patent Case

 
• By 

Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.