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The number of patent lawsuits filed over generic drug challenges has spiked this year, a development that coincides with the widely anticipated “patent cliff” of many brand drugs losing protection. Read More
AstraZeneca has filed a patent infringement lawsuit against Actavis subsidiary Watson over a proposed generic version of AZ’s diabetes drug Kombiglyze XR. Read More
The FDA said two generic versions of Janssen’s attention deficit hyperactivity disorder drug Concerta may not be therapeutically equivalent to the brand, a decision that could result in the products being withdrawn. Read More
India’s final guideline on drug patent applications drops a proposed clause that would have required manufacturers to list names of similar generic products in their filings. Read More
A federal judge has dismissed claims brought by a group of pharmacies that Pfizer and Ranbaxy forged an illegal deal to delay generic competition to Pfizer’s cholesterol drug Lipitor, marking another victory for the manufacturers in the class action filing. Read More
An HHS watchdog will audit how the FDA inspects generics manufacturing facilities, oversees postmarketing studies and ensures compliance with clinical trial reporting requirements, as well as how the drug industry is implementing the track-and-trace law. Read More
Amgen is asking the FDA to require that all biosimilar filers send a full copy of their application to the innovator company, a position that parallels the company’s lawsuit opposing Sandoz’s bid to make a version of its chemotherapy product Neupogen. Read More
Pharmaceutical intellectual property rights remain a significant sticking point in a proposed draft of the massive Trans-Pacific Partnership (TPP) trade pact leaked last month. Read More
Cipla has asked the Indian government to forcibly revoke five patents covering Novartis’s lung disease drug Onbrez to pave the way for generic versions in the country, a move the Indian manufacturer says is needed to address a significant unmet need for the therapy. Read More
Generic drug prices in Canada are up to seven times more expensive than those in comparable countries, according to a study that challenges a major price-setting deal between Canadian generics firms and provincial governments. Read More
An Indian pharma group contends the U.S. Trade Representative’s scrutiny of India’s intellectual property regime could dampen investment in the country. Read More
To make it easier for generics firms to create versions of complex drugs, the FDA is asking industry to identify drug products it would like to see bioequivalence testing guidances written for. Read More