Thomson Reuters' series of reviews covering all aspects of the pharmaceutical marketplace, Pharma Matters.
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JANUARY - MARCH 2009
It is 25 years since the Drug Price Competition and Patent Term Restoration Act, commonly known as the “Hatch-Waxman” Act, created the US generic industry as we know it. Today two thirds of all prescriptions dispensed in the US are for generic equivalents.
Newport Horizon Premium was there to join the celebrations at the Generic Pharmaceutical Association (GPhA) 2009 Annual Meeting in Naples, Florida. Via a taped message, the Act’s sponsor, Congressman Henry Waxman, expressed his belief that the Hatch-Waxman model still achieves a strong balance between fostering innovation and making affordable medicines available to consumers.
OPENING MOVES
Based on our research of ANDA filings and paragraph IV challenges, we highlight some of the companies making significant game play in the US generics industry.
- Beijing Double-Crane Pharmaceutical Co Ltd
In 2008, unnoticed by many, Beijing Double-Crane Pharmaceutical Co Ltd became the first Chinese company to hold a final ANDA approval in the US, when it acquired Ranbaxy’s ANDA 78039 for meloxicam 7.5mg and 15mg tablets. - ThePharmaNetwork, LLC
Based in Montvale, New Jersey, with offices in Hyderabad, India, and Beijing and Shanghai, China, ThePharmaNetwork (TPN) has two ANDA approvals under its own name, for benzonatate capsules in 100mg and 200mg strengths. - Novel Laboratories
At the end of 2008, Novel Laboratories (based in Somerset, New Jersey) achieved approval for one ANDA in its own name — sodium polystyrene sulfonate rectal powder.
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JANUARY - MARCH 2009
The main news story as we go to press, eclipsing all others, is the sudden appearance and rapid spread of the influenza A virus subtype H1N1, first identified in April 2009 in the US and traced to a seasonal flu outbreak in Mexico.
It’s too early to assess the epidemic’s true significance, but it’s safe to say that H1N1 is putting yet more pressure on the pharmaceutical industry. The political exposure may well turn out to be beneficial for the industry, increasing funding and stimulating research, but the outbreak also reveals a public that is impatient for a cure and easily scared.
Thomson Reuters is adding its knowledge and expertise to the fight against this and further influenza A epidemics. We are pleased to offer, free to download by any interested party, our entire disease briefing on influenza, taken direct and unabridged from the wealth of information and knowledge in our investigational drug database Prous Science Integrity® and updated daily.
You can download it at science.thomsonreuters.com/pharma/h1n1/
THE FIVE MOST PROMISING DRUGS LAUNCHED OR RECEIVING APPROVAL
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JANUARY - MARCH 2009
The international pharmaceutical industry is among the most important sponsors of scientific research, so it is understandable that some of the most widely published authors of scientific articles are affiliated with, or sponsored by, pharmaceutical companies.
In this quarterly review of the scientific literature on drugs and therapies, Thomson Reuters has assessed the quantity and quality of the materials published by pharmaceutical companies, research institutions and other non-commercial bodies in the last three months to identify which organization has made the biggest splash.
The Organizations that have made the biggest impact in the leading sources of information on medical research
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