Generics
India and EU to resolve generic drug dispute
India will resolve a dispute with the EU over generic drugs in an amicable way, Trade Minister Anand Sharma said on 6 November 2009.
Competition in China’s generic drug market intensifies
Patent protection for 35 kinds of the best-selling drugs is on track to expire by 2010, including medicines for the treatment of ulcers, hypertension and hyperlipemia. This is expected to have a major impact on the Chinese pharmaceutical industry, where generic drugs account for 97% market share. Industry analysts pointed out that although China has a large production scale of generic drugs, the level of technology remains relatively low. China is home to more than 6,000 pharmaceutical makers. Most of them battle it out at the low end of the price scale with the result that, the country’s profit margin in generic drugs is only equal to one-sixth of the international average.
Generics drive Dr Reddy's Q2 revenues up 14%
On 23 October 2009, Dr Reddy's Laboratories in India reported a 14% increase in consolidated revenues to Rs18.4 billion (Euros 263.94 million) for the second quarter that ended on 30 September 2009, driven by growth in the generics business.
FDA compared generic and innovator drugs based on 12 years of bioequivalence data
In the US, manufacturers seeking approval to market a generic drug product must submit data demonstrating that the generic formulation provides the same rate and extent of absorption as (i.e., is bioequivalent to) the innovator drug product. Thus, most orally administered generic drug products in the US are approved based on results of one or more clinical bioequivalence studies.
Exposure-response analysis on bioequivalent carbamazepine tablets not clinically relevant proof for toxicity differences
Generic immediate-release carbamazepine tablets are AB-rated generic versions of Novartis’s Tegratol. In this market, Taro is the leading supplier with half the market. Teva Pharmaceutical Industries Ltd follows with more than a quarter of the market, and Sun’s Caraco is the third-leading supplier with a share of about 18%. The only other supplier currently in the market is Apotex.
Post-marketing pharmacokinetic bioequivalence between generic and branded amoxicillin formulations
Amoxicillin is a moderate-spectrum, bacteriolytic, β-lactam antibiotic used to treat bacterial infections caused by susceptible microorganisms. It is usually the drug of choice within the class because it is better absorbed, following oral administration, than other β-lactam antibiotics.
Switching statins in Norway after new reimbursement policy
Norwegian scientists assessed the changes in statins prescribing in Norway after implementation of the new reimbursement regulations for statins in June 2005, as published in the British Journal of Clinical Pharmacology of October 2007 by Ms Solveig Sakshaug of the Norwegian Institute of Public Health in Oslo.
Possible economic benefits from generic and therapeutic statin substitution
The group of Associate Professor O Klungel of Utrecht University, The Netherlands, assessed the potential annual savings due to generic and therapeutic substitution of statin therapy for the general Dutch population, taking the patients’ medical histories into account. Pearl Gumbs and colleagues published the study in the British Journal of Clinical Pharmacology in November 2007.
Actavis launches generic challenge to Pfizer’s Lipitor
On 1 October 2009, Actavis, the Iceland-based generic company, launched the most high-profile commercial challenge in Western Europe to Pfizer’s best-selling and patent-protected medicine.
Many potential buyers as sale of Ratiopharm begins
The process of divesting Ratiopharm, the world's fourth-largest generic drugmaker, owned by the conglomerate formerly run by German billionaire Mr Adolf Merckle who committed suicide at the start of the 2009 is underway.
