Patent Litigation Settlement_ALOXI, Reddys and Helsinn
Swiss pharmaceutical firm Helsinn Healthcare SA on October 13th 2015 said it has settled patent litigations relating to its anti-nausea injection Aloxi with Dr. Reddy’s Laboratories Ltd.
The settlement will allow Dr. Reddy’s to market the generic version of Aloxi in the US on 30 September 2018 or earlier under certain circumstances, Helsinn said in a statement.The terms of the settlement agreement were not disclosed.
Aloxi generically called as palonosetron HCl injection is a drug, marketed by Japanese Eisai Co. in the US and Canada, to treat chemotherapy-induced nausea and vomiting in patients suffering from cancer.
Aloxi has sales of nearly $416 million in the US and Canada for the year ended 31 March.
Orange Book Data Listed Patent:
| Appl No | Patent No | Patent | Drug Substance | Drug Product | Patent Use |
| Expiration | Claim | Claim | Code | ||
| N021372 | 5202333 | 13-Apr-15 | Y | Y | U – 528 |
| N021372 | 5202333*PED | 13-Oct-15 | |||
| N021372 | 7947724 | 30-Jan-24 | Y | ||
| N021372 | 7947724*PED | 30-Jul-24 | |||
| N021372 | 7947725 | 30-Jan-24 | Y | ||
| N021372 | 7947725*PED | 30-Jul-24 | |||
| N021372 | 7960424 | 30-Jan-24 | Y | ||
| N021372 | 7960424*PED | 30-Jul-24 | |||
| N021372 | 8518981 | 30-Jan-24 | Y | ||
| N021372 | 8518981*PED | 30-Jul-24 | |||
| N021372 | 8598218 | 30-Jan-24 | Y | ||
| N021372 | 8598218*PED | 30-Jul-24 | |||
| N021372 | 8598219 | 30-Jan-24 | Y | ||
| N021372 | 8598219*PED | 30-Jul-24 | |||
| N021372 | 8729094 | 30-Jan-24 | Y | U – 528 | |
| N021372 | 8729094*PED | 30-Jul-24 | |||
| N021372 | 9066980 | 30-Jan-24 | Y | U – 528 | |
| N021372 | 9125905 | 30-Jan-24 | Y |
In January, Helsinn reached a similar settlement with Sandoz Inc, allowing Sandoz to launch generic Aloxi in US from September 2018 onwards.
The case began in 2011 when Dr. Reddy’s, Teva and Sandoz filed applications to create generic versions of the drug, which is distributed by Eisai in the US.
Helsinn filed a complaint against the three generic manufacturers for alleged infringement of patents related to Aloxi, in the US District Court of the District of New Jersey on 30 September 2013 after they submitted Abbreviated New Drug Applications (ANDAs) seeking approval from US Food and Drug Administration (USFDA) to launch the copy version of the drug.
The court ruled in Helsinn’s favour, holding that Sandoz “sought Food and Drug Administration approval” of its generic version of Aloxi, despite it knowing about Helsinn’s patent.
An injunction was issued, preventing the generic manufacturers from launching and selling their versions.
In May, USFDA approved the paediatric version of the drug, extending the marketing exclusivity by six more months.
The market exclusivity of the drug ends in October in the US, though two of the patents of Aloxi are valid up to 2024
