Tag: Paragraph IV certification
Why the First Generic Filer Gets 180-Day Exclusivity in the U.S. Drug Market
The first generic drug company to file a patent challenge gets 180 days of exclusive sales rights. But this rule, meant to lower drug prices, is often manipulated-delaying competition and keeping patients from affordable medicines.
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Methadone can prolong the QT interval on an ECG, raising the risk of life-threatening arrhythmias. Learn who’s at risk, when to monitor, and how to stay safe while in treatment.
Published ON: 8 DecPatent exclusivity and market exclusivity are two different legal tools that protect new drugs. One comes from the patent office, the other from the FDA. Understanding the difference explains why drug prices stay high-and who controls when generics arrive.
Published ON: 10 DecAntacids like Tums and Milk of Magnesia can be dangerous for people with kidney disease. Learn how calcium, aluminum, and magnesium in these meds affect phosphate levels, heart health, and kidney function - and what safer options exist.
Published ON: 6 DecLithium carbonate generics require careful serum level monitoring due to their narrow therapeutic window. Switching between brands can alter blood levels, risking toxicity or relapse. Learn safe targets, testing schedules, and how to avoid dangerous interactions.
Published ON: 1 DecContamination controls in generic drug manufacturing prevent harmful residues and microbes from entering medicines. Learn how cleanrooms, real-time monitoring, and human factors impact drug safety-and what’s changing by 2025.
Published ON: 11 Dec