RE:RE:RE:RE:RE:Performance and ComplaintsCancerSlayer wrote: rollthedice10 wrote: Hopefully by the time our patents expire we will be so far out front
catching up to TLT would be quite a chore. Remember a competitor
would have years of trials and FDA as well. And as I opined in a previous
post, I'm sure TLT will be applying for many more patents as well.
A competitor would have to consider TLT market share at the time
as well as any new restrictive TLT patents
before embarking on that long expensive journey. JMHO
Having that first-mover advantage & brand name recognition may be difficult to overcome by any potential generic manufacturer, especially if there is little incentive for generic production due to new pricing not significantly undercutting brand name pricing...jmo.
Although a generic manufacturer doesn't have to reproduce a full clinical trial (to my understanding), it would have to prove bioequivalence using GMP, which is not a simple/slam-dunk task & it could take years to ultimately achieve FDA approval. If approved, there can also be significant limitations & delays regarding provider/patient/market transitioning & acceptance.
With regards to additional proprietary protection after patent expiration (June 2034), a Theralase NR, dated on June 20, 2016, states: "Under worldwide exclusive licence agreement with the inventor of the latest patent, Dr. Sherri McFarland has agreed to maintain strict confidentiality on any trade secrets associated with the synthesis or manufacture of TLD-1433 for a period of twenty (20) additional years following the expiry of the last patent covering inventions or improvements in compounds or their methods of use; thereby, increasing minimum proprietary protection of TLD-1433 in the US until June 22, 2054."
"Behind BMS, Merck faces the next greatest threat of exposure from 2025-2030 at 47% of its $72 billion in estimated 2025 revenue, the Leerink team said. Naturally, the companys immuno-oncology cash cow Keytruda is the biggest liability, with a U.S. loss of exclusivity closing in by 2028. Januvia, Bridion and Lynparza could also prove troublesome for the New Jersey drug giant, with U.S. LOEs slated to hit in 2026 and 2027. With that in mind, Merck has ample cash on hand to forge deals, with management expressing an appetite for assets across all stages of clinical development, according to Leerinks M&A report. From a capacity perspective, just to be clear, we continue to think we have capacity, frankly, to do pretty much anything of any size, Mercks CEO, Robert Davis, said on a recent analyst call. But our focus area continues to be mainly in that $1 billion to $15 billion range. Meanwhile, Merck as of 2024s third quarter had tripled the number of phase 3 assets in its pipeline from the same period three years ago, so, we have a lot there, but we need to add more, Davis said. He added that the company is keeping its eyes peeled for enticing candidates across all therapeutic areas.