Dec. 5, 2014, 12:56 PM
- A jury in the U.S. District Court for the District of Massachusetts returns a verdict in favor of AstraZeneca (AZN -0.2%) in a lawsuit brought by various purchaser groups challenging its settlement of Nexium patent litigation with Ranbaxy Laboratories (OTC:RBXLY) (OTC:RBXZF).
- Two similar cases in Pennsylvania are still pending.
- Previously: AstraZeneca could face hefty damages in Nexium case (Dec. 3, 2014)
Dec. 3, 2014, 9:34 AM
- German regulators bar the importation of the antibiotic cephalosporin made by Indian drug firm Ranbaxy Laboratories Ltd (OTC:RBXLY) (OTC:RBXZF). The action stems from manufacturing deficiencies noted during an on-site inspection of the company's Dewas site.
- Ranbaxy is also barred from exporting to the U.S. after FDA inspectors observed similar deficiencies.
- The company says it is working to resolve the issues.
- Previously: Indian generic firms woes benefit others
- Previously: Indian generic-drug firms involved in recalls
Dec. 3, 2014, 7:36 AM
- AstraZeneca (NYSE:AZN) could be on the hook for substantial damages if it loses a trial in Boston involving Ranbaxy Laboratories Ltd. (OTC:RBXLY) (OTC:RBXZF) and their pay-to-delay agreement that blocked generic competition to Nexium. This is first such trial since the U.S. Supreme Court ruled that companies can be sued over these deals if the payments are large and unjustified.
- The suit challenges a 2008 settlement of a patent dispute between the two companies that postponed the entry of generic competition until this year. Plaintiffs argue that the $1B+ that Ranbaxy received violated antitrust law and was excessive for a patent case.
- Teva Pharmaceutical Industries (NYSE:TEVA) was also a defendant in the case but it reached a settlement with the plaintiffs after four weeks of testimony.
- If the plaintiffs win, there will be another trial to determine the amount of damages. A win, though, is far from certain because the drug buyers have failed to show that they were harmed by the deal. Two weeks into the trial, AstraZeneca filed a motion to throw out the claims on the basis that the plaintiffs' experts failed to offer evidence of what they regard as proper royalty rates for drugs, a stipulation made by the court for the trial to proceed. Judge William Young denied the motion without elaborating.
- Nexium generated almost $4B in sales last year.
Oct. 16, 2014, 12:50 PM
- Without admitting to any wrongdoing, Merck's (MRK -2%) Organon unit agrees to pay $31M to settle allegations that it overcharged several states' Medicaid programs. Organon also allegedly offered kickbacks to nursing home pharmacies to support the use of its Remeron antidepressant and promoted it for non-approved indications.
- Merck acquired Organon as part of its takeover of Schering-Plough in 2009.
- Indian generic firm Ranbaxy Laboratories (OTC:RBXLY) agrees to pay almost $40M to Texas to resolve allegations that it violated the Medicaid Fraud Prevention Act there by charging inflated prices.
Apr. 7, 2014, 3:32 AM
- Sun Pharmaceutical Industries has agreed to acquire fellow Indian company Ranbaxy Laboratories (RBXLY) for $3.2B in an all-stock deal that will create the world's fifth-largest generic-drug maker. Including the debt, the transaction is worth $4B.
- The merger combines two firms that have had problems with quality issues. Ranbaxy, which is owned by Japan's Daiichi Sankyo (DSKYF), is banned from selling ingredients to the U.S., while Sun's Karkhadi facility is also not allowed to export products to the U.S. (PR)
Mar. 10, 2014, 8:51 AM
- Indian generic-drug makers Sun Pharmaceutical Industries and Ranbaxy Laboratories have recalled batches of treatments in the U.S. following complaints of bottling mix-ups.
- Sun Pharma diabetes tablets were found with an epilepsy medication, while Ranbaxy pulled two batches of its version of Pfizer's Lipitor cholesterol drug.
- The recalls come amid increasing scrutiny of generic drugs manufactured in India and of Ranbaxy (RBXLY) in particular - four of its plants are banned from exporting to the U.S. after failing to meet FDA strictures.
- Ranbaxy is owned by Japan's Daiichi Sankyo (DSKYF).
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