Alimta and Orfadin generics approved by FDA

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The US Food and Drug Administration (FDA) has tentatively approved Mylan’s pemetrexed, a generic version of Eli Lilly’s cancer drug Alimta, and approved Novitium Pharma’s generic equivalent of Swedish Orphan Biovitrum's Orfadin (nitisinone capsules).


Alimta is a chemotherapy currently used to treat non-squamous non-small cell lung cancer and mesothelioma. The tentative approval of Mylan’s generic version of Alimta will allow it to be marketed in the US in 2022 following the expiration of Lilly’s patents. In August 2019, Lilly successfully defended Alimta’s patents against challenges from Pfizer’s Hospira unit and Dr Reddy’s Laboratories in court. The two companies were attempting to launch alternative salt versions of pemetrexed in the US prior to the expiration of Alimta’s patent. Following the verdict, Lilly announced ‘If the patent is ultimately upheld through all remaining challenges, Alimta would maintain US exclusivity until May 2022, preventing marketing of generic products for as long as the patent remains in force’.

Mylan is not the first company to develop a generic version of Alimta. In 2017, US-based Eagle Pharmaceuticals was granted tentative approval for its Alimta generic Permfexy [1]. In June 2019, a number of German generics manufacturers won a patent litigation case against Lilly, resulting in the lifting of sales injunctions for Alimta generics including products from Hexal and Fresenius. Another generics manufacturer Stada launched its generic version of Alimta in 2018.

Lilly has been seeking new indications to protect its share of the pemetrexed market, which was valued at US$2.06 billion in 2017 by Coherent Market Insights. In January 2019, FDA granted approval for Alimta in combination with Merck’s Keytruda as a first-line treatment of metastatic non-squamous non-small cell lung cancer.

The tentative approval of Mylan’s pemetrexed generic comes after Pfizer announced plans to merge its Upjohn unit with Mylan to create a US$9.5 billion generics giant.

Two important developments marked the start of September for Endo International. Firstly, Endo announced that Novitium Pharma, a partner of its subsidiary Endo Ventures, was granted FDA approval for its room-temperature stable generic drug equivalent of Swedish Orphan Biovitrum's Orfadin (nitisinone capsules). Nitisinone capsules are indicated for the treatment of adult and paediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Par Pharmaceutical, one of Endo's operating companies, expects to start distributing the product through specialty pharmacies this month.

Secondly, Endo announced that Par Pharmaceutical has begun shipping an authorized generic version of Merck's Noxafil (posaconazole) delayed-release tablets, 100 mg. Endo Ventures recently entered into an exclusive supply and distribution agreement in the US with a subsidiary of Merck, allowing Par to launch and distribute an authorized generic version of the product. This agreement also includes rights to posaconazole 40 mg/mL oral suspension, which Par intends to launch over the next few months.

‘Par is pleased to provide patients and providers with access to a lower-cost treatment through our launch of the authorized generic version of Noxafil’, said Domenic Ciarico, Executive Vice President and Chief Commercial Officer, Sterile and Generics at Endo.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA tentatively approves pemetrexed generic []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 11]. Available from:

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