Glenmark Generics, the US subsidiary of drug-maker Glenmark Pharmaceuticals, has filed a lawsuit in a Delaware court in the US against six drug-makers for violating its180-day exclusivity rights to market Hydrocortisone Butyrate Cream 0.1%.
The six companies – Astellas Pharma Europe, Astellas International, Triax Pharmaceuticals, Precision Dermatology, Onset Dermatologics and Metacon Labs – launched a generic version of Locoid Lipocream well before the exclusivity period ended.
The cream is used for relief from certain skin conditions. According to IMS Health, the cream generated sales of around $34 million in the 12-month period to June 2013.
Glenmark Pharma was the first company to file an abbreviated new drug application (Anda) for the generic version of Locoid Lipocream in the US market, the company informed BSE.
Through the lawsuit, Glenmark is seeking a temporary restraining order or TRO against sale, manufacturing or marketing of the cream by the six companies during its exclusivity period.
Last week, Glenmark had received the US Food and Drug Administration (FDA) approval to launch a Locoid Lipocream copy. Its generic was scheduled to hit the market in December this year.
However, Metacon had launched a generic equivalent, prompting Glenmark to file a lawsuit against the former earlier this week.
If Metacon is found guilty, the court would ask it to stop selling the generic product, experts said. “It is difficult to predict as the order could also allow Metacon to sell the generic version until a final decision is arrived, if the court accepts any Metacon contention that it had effected some changes in the molecule, making it a different product,” said a pharma analyst.
Industry experts said that typically in such lawsuits, a stay order can be expected in the next 10-12 days. And Glenmark may well get some relief. “The final verdict will take time to come by. And if Glenmark has a strong case, it is likely to also seek damages from Metacon, which could be a percentage of the total sales of the product,” said another analyst familiar with such patent lawsuit matters.
Protecting its turf
The six firms are said to have violated Glenmark’s 180-day exclusivity on Hydrocortisone Butyrate Cream 0.1%
Glenmark was the first to file an abbreviated new drug application (Anda) for the generic version of Locoid Lipocream in the US market
The cream generated sales of around $34 million in the 12-month period to June 2013
A stay order can be expected in the next 10-12 days; but the court ruling can go either way