UPCOMING POTENTIAL LAUNCHES
Aciphex: Potential launch 11/8/13.
Asacol: Potential launch 7/30/13.
Cymbalta: Potential launch 12/11/13.
Focalin XR: Potential launch in Q3 2013.
Lidoderm: Potential launch in Q3 2013.
Mirapex ER: Potential launch in August.
Niaspan: Potential launch 9/20/13.
Soriatane: Potential multi-supplier launch in Q3 2013.
Generic versions of Trilipix launches
Mylan announced the launch of fenofibric acid delayed-release capsules 45mg and 135mg, a generic version of Abbott's Trilipix. Various versions of the drug had sales of approximately $553.6 million during the 12-month period that ended in March, according to IMS Health. (DrugStoreNews 7/15/13, DrugStoreNews 7/18/13)
Generic version of Prandin launches
Sun announced the approval of repaglinide tablets 1mg and 2mg, a generic version of Novo Nordisk's Prandin. Prandin is used in combination with diet and exercise to improve blood-sugar control in patients with Type 2 diabetes and has annual sales of approximately $200 million, according to Sun. As the first company to successfully file for approval, Sun is eligible for 180 days of market exclusivity in which to compete directly with Novo Nordisk's version. (DrugStoreNews 7/12/13)
Perrigo receives tentative FDA approval for generic Prandin
Perrigo announced the tentative approval for repaglinide tablets, a generic version of Novo Nordisk's Prandin. Tentative approval means that the drug meets the basic conditions for FDA approval, but the agency must wait to grant final approval until patent-protection or market exclusivity periods have ended; in the case of Prandin, Sun received approval for its generic and will have 180 days in which to compete exclusively with Novo Nordisk's product. Prandin has annual sales of approximately $250 million, according to Symphony Health Solutions. (DrugStoreNews 7/19/13)
Generic version Soriatane launches
Teva announced the availability of the acitretin capsules 10mg, 17.5mg and 25mg, a generic version of GlaxoSmithKline's Soriatane. (DrugStoreNews 7/22/13)
Mylan files ANDA for generic Canasa
Mylan announced it had filed an ANDA with the FDA for melamine rectal suppositories 1,000mg, a generic version of Aptalis' Canasa. Mylan's application contained a Paragraph IV certification, a legal assertion that patents covering the drug are invalid, unenforceable or not in danger of infringement. In response to the filing, Aptalis filed a patent-infringement suit against Mylan. Under regulations governing generic drugs, Mylan expects to be eligible for 180 days of market exclusivity after FDA approval. Canasa had sales of approximately $153 million during the 12-month period that ended in March, according to IMS Health. (DrugStoreNews 7/11/13)
FDA approves generic Lamictal ODT
Actavis announced that it received FDA approval for lamotrigine orally disintegrating tablets 25mg, 50mg, 100mg and 200mg, a generic version of GlaxoSmithKline's Lamictal ODT. Actavis said it was likely the first company to file a complete ANDA for a generic version of Lamictal ODT and, as such, would be eligible for 180 days of market exclusivity in which to compete directly with the branded version. Lamictal ODT had sales of approximately $51 million during the 12-month period that ended in May, according to IMS Health. (DrugStoreNews 7/16/13)
Lupin receives FDA approval for generic GIumetza Extended-Release Tablets
Lupin announced that it received final FDA approval for its Metformin Hydrochloride extended release tablets 500mg and 1000mg, the AB-rated generic equivalent of Santarus' Glumetza HCl ER tablets. Glumetza is a biguanide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. According to IMS Health data, Glumetza HCl ER tablets had U.S. sales of approximately $144 million for the twelve months that ended March 2013. Lupin believes that it is the first applicant to file an ANDA for Glumetza HCl ER tablets and as such will be entitled to 180 days of marketing exclusivity. (Rtt News 7/22/13)
IMS Health study identifies $200+ Billion annual opportunity from using medicines
Avoidable costs exceeding $200 billion are incurred each year in the U.S. healthcare system as a result of medications not being used responsibly by patients and healthcare professionals, according to a new study released by the IMS Institute for Healthcare Informatics. This represents 8 percent of the country's total annual healthcare expenditures and amounts to millions of avoidable hospital admissions, outpatient treatments, pharmaceutical prescriptions and emergency room visits.The report - Avoidable Costs in U.S. Healthcare: The $200 Billion Opportunity from Using Medicines More Responsibly - examines six areas that contribute to unnecessary costs: medication nonadherence, delayed evidence-based treatment practice, misuse of antibiotics, medication errors, suboptimal use of generics and mismanaged polypharmacy in older adults. Together, these areas lead to unnecessary utilization of healthcare resources involving an estimated 10 million hospital admissions, 78 million outpatient treatments, 246 million prescriptions and four million emergency room visits annually. The study found significant opportunities for improvement - to ensure that patients receive the right medicines at the right time, and take them in the right way. (imshealth.com 7/19/13)