Speciality topical generics maker IGI Laboratories (IGI Labs) announced on 25 September 2014 that it had acquired the rights for 18 drugs from AstraZeneca.
The acquisition marks a move into injectable products for US-based IGI Labs, with 17 of the products being injectables and one being a suppository product.
The move is good news for the US, where drug shortages of sterile injectables have been plaguing the country [1]. The problem is that when drugs go off patent many companies no longer find it profitable to continue making difficult-to-manufacture sterile injectables, as can be seen here in the case of AstraZeneca.
In fact, most drug shortages involve generic sterile injectables, and in 2011, these accounted for 73% of all reported drug shortages [2].
IGI Labs President and CEO, Mr Jason Grenfell-Gardner, also points out that ‘almost half of the products we acquired are currently listed on the US Food and Drug Administration (FDA) shortage list, and we look forward to working closely with the US FDA to return these products to the market as soon as possible’.
Other companies have also seen a market in generic sterile injectables. Hikma Pharmaceuticals (Hikma) signed a long-term commercial supply contract with Unilife Corporation (Unilife) for the use of Unifill pre-filled syringes with a range of generic injectable drugs in November 2013 [3]. While generics maker Zydus Cadila, the fifth largest pharmaceutical company in India, announced a US$15.8 million investment in building an FDA-approved injectables manufacturing plant in August 2013 [4]. And medical technology company Becton Dickinson had its first drug in its line of pre-filled generic injectables approved by the US FDA in March 2013 [5].
Although not a huge deal, IGI Labs estimates the US market for these 18 products to be worth US$200 million.
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References
1. GaBI Online - Generics and Biosimilars Initiative. US drug shortages – frustration and safety concerns [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 17]. Available from: www.gabionline.net/Reports/US-drug-shortages-frustration-and-safety-concerns
2. GaBI Online - Generics and Biosimilars Initiative. Drug shortages linked to quality control costs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 17]. Available from: www.gabionline.net/Pharma-News/Drug-shortages-linked-to-quality-control-costs
3. GaBI Online - Generics and Biosimilars Initiative. Hikma makes deal to enhance delivery of generic injectables [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 17]. Available from: www.gabionline.net/Generics/News/Hikma-makes-deal-to-enhance-delivery-of-generic-injectables
4. GaBI Online - Generics and Biosimilars Initiative. Generics manufacturers increase investment in injectables [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 17]. Available from: www.gabionline.net/Pharma-News/Generics-manufacturers-increase-investment-in-injectables
5. GaBI Online - Generics and Biosimilars Initiative. New entrant to generic injectables market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 17]. Available from: www.gabionline.net/Generics/News/New-entrant-to-generic-injectables-market
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