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Dr. Reddy's Laboratories Ltd.

www.drreddys.com

Latest From Dr. Reddy's Laboratories Ltd.

OTC Decisions In March: Lumify Single-Use, Aleve Arthritis-Grip Cap Labeling, And More Prilosec, Mucinex Copies

Total of CDER decisions during March on OTC applications was down from January and February and also were less substantial for the marketplace. After approving OTC switches in first two months, March decisions for newly available OTCs were limited to additional guaifenesin/pseudoephedrine and omeprazole products offered as private label/store brand alternatives to brands.

OTC Drugs FDA

Amarin's Vascepa May Face Generic Competition In US Next Year After Patents Ruled Invalid

Amarin had argued that Vascepa’s sales success showed that its patents were not obvious, but the court found otherwise, even as it concluded that Hikma, Dr. Reddy's and West-Ward has infringed on the fish oil pill's patents.

Legal Issues Intellectual Property

Amarin's Vascepa May Face Generic Competition In US Next Year After Patents Ruled Invalid

Amarin had argued that Vascepa’s sales success showed that its patents were not obvious, but the court found otherwise, even as it concluded that Hikma, Dr. Reddy's and West-Ward has infringed on the fish oil pill's patents.

Legal Issues Intellectual Property

Dr Reddy’s And Hikma Win Big On US Vascepa Patents

In a surprise to the market, Dr Reddy’s and Hikma have prevailed in challenging six method-of-use patents shielding Amarin’s Vascepa in the US, opening the door for a potential at-risk launch that would likely be challenged by the originator.

Intellectual Property Legal Issues
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