Month: September 2022

PARAGRAPH IV CERTIFICATIONS are how generic companies expedite the launch of an ANDA for a generic competitor to an expiring patent of a brand drug that is bioequivalent to the innovator drug. Here is a useful primer of this complex arena. " " http://lnkd.in/ddwrqrE View in LinkedIn

THE PHARMA PATENT CLIFF. By 2016, the pharma industry will have total patent losses of ~$150 billion." Brand pharma has exclusivity from IP and commands top pricing. When the patents expire, there is intense competition from generics to take market share. First-to-file generics get 180 day market exclusivity, at a lower price. When the exclusivity protection ends, other generics can enter the market and price erodes further. These are the dynamics of a pharma product life-cycle." " http://lnkd.in/dRzKvfa View in LinkedIn

ANALYSIS OF PARA IV LAWSUITS. A recent study analyzed over 370 court rulings since the beginning of 2000 to 2009 to determine success rates. "The authors hypothesize that, based on the incentives of the Hatch-Waxman first-to-file structure, every (pharma) patented product would be challenged."" " http://lnkd.in/dc6W3aBhttp://lnkd.in/dbyhKdY View in LinkedIn

STRESS TEST PHARMA PATENTS before filing by sending to a pharma patent litigator to throw a nuclear bomb at it and find the weaknesses. When found, patch them up to the best of your ability. All pharma patents of value will end up in court. View in LinkedIn

GIANT SAVINGS FROM GENERICS DRUGS. "A series of studies estimated the total savings that have accrued to the U.S. health care system from substituting generic drugs for their brand-name counterparts, and found that from 1999 through 2010 doing so saved more than $1 trillion. On average, the retail price of a generic drug is 75 percent lower than the retail price of a brand-name drug."" " http://lnkd.in/d72m-_h View in LinkedIn

PHARMA INDUSTRY STATS. "In 2012 brand companies earned $156.3 Bn, and generics $52.8 Bn, or combined $209 Bn or 1.34% of the economy. There were 2707 brand companies employing 244,000 staff, and 3103 generics employing 76,000 staff. Between 2012-2017 brand will grow 0.4% and generics 6.3% in part due to the Patent Cliff and in part due to Obamacare."" "" " http://lnkd.in/dvtVN7r View in LinkedIn

US PHARMA MARKET IS NOW 84% GENERIC."It’s been nearly 30 years since Congress kick-started the generic drug industry by passing the Hatch-Waxman Act, the 1984 law that made it easier for pharmaceutical companies to sell copycat pills as long as they could prove the drugs were identical to the brand-name versions. Today, the Food and Drug Administration and nearly every other major health authority agree that generic drugs are safe and effective."" " http://lnkd.in/dgiDXd7 View in LinkedIn

BIOLOGY DRIVES CHANGE. Pharma is moving from small molecules to protein therapeutics driven by biotechnology. The chemical industry is also (slowly) looking to change, also driven by biotechnology. The chemical industry is largely based converting fossil fuels into useful chemicals. The challenge of the coming years is to use engineered microbes to make the same petroleum-based products cheaper and with little or no toxic waste. Clearly, the market transitions will be significant. View in LinkedIn

THE ECOCHEM CONFERENCE in Basel Switzerland (Nov 19-21) was an event with many senior people from big industry players. I expected a lot of 'Greenwash' but was impressed by the apparent seriousness of some industry giants to strive to be greener. I was especially impressed by the prevailing strong optimism, and the focus on viable solutions. Some hybrid solutions were presented that conjoined green and petrochemical products. A realistic compromise given the installed capital basis in the giant chemicals industry. View in LinkedIn

THE INDUSTRIAL REVOLUTION (1760-1840) and the resulting industrial economy based on new mechanized manufacturing methods and on oil was a relatively recent event in mankind's history, and "the most important event in the history of humanity since the domestication of animals and plants." Like any phenomenon, this continues to evolve. Today, we see the emergence of cleaner synthesis methods, and a growing environmental awareness, combined with a move towards renewable natural resources and a desire to not be totally reliant on fossil fuels. http://lnkd.in/dEUH_NS View in LinkedIn