Bioequivalency Branding Drugs 
Drug Patent Watch
DECEMBER 12, 2024
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.
FDA Law Blog
APRIL 8, 2025
As folks steeped in the world of generic drugs And Hatch-Waxman know, theres a lot that happens before FDA can take action on an ANDA. Leading FDAs implementationof the Drug Competition Action Plan (DCAP). And DPD was a significant piece of that puzzle. the ICH M13A batch ), totaling more than 3,000 PSGs (includingPSG revisions).
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Pharmaceutical Technology
JULY 25, 2022
Specialty generics is a term used to refer to generic versions of drugs that are often expensive, complex, or “high touch”—requiring significant involvement of service to manage. Specialty drugs are most used to treat different cancers, rheumatoid arthritis, and multiple sclerosis. The only way forward for generics producers.
World of DTC Marketing
FEBRUARY 21, 2022
Experts across the board are predicting demand for antiviral drugs will rapidly outpace supply. Pfizer and Merck have chosen to designate a select few generic manufacturers to produce cheaper versions of their drugs through the Medicines Patent Pool (MPP). Reportedly, the cost of production for molnupiravir stands at about $17.74.
Drug Patent Watch
DECEMBER 30, 2024
The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) The PMDA is the primary regulatory authority responsible for overseeing the drug approval process in Japan.
Drug Patent Watch
OCTOBER 7, 2024
Pharmacokinetics (PK) plays a crucial role in the development and approval of generic drugs. PK studies help ensure that generic drugs are bioequivalent to their brand-name counterparts, meaning they have similar absorption, distribution, metabolism, and excretion (ADME) profiles.
Drug Patent Watch
JANUARY 14, 2025
The Generic Drug Revolution: Setting the Stage Before we dive into the nitty-gritty, let’s take a moment to appreciate the impact of generic drugs. Did you know that generic drugs now make up about 90% of all prescription drug purchases in the United States, while accounting for only 20% of prescription drug spending[1]?
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