Scientific Rationale and Structural Differences Do Matter.Though all these drugs are Angiotensin II Receptor Blockers (ARBs), their molecular structures differ slightly, which affects the following thing-
1)Receptor binding affinity
2)Half-life
3)Tissue selectivity
4)Side-effect profiles
5)Bioavailability

These differences can impact clinical outcomes, e.g., one drug may be preferred in patients with kidney disease or diabetes due to more favorable renal outcomes.

For FDA Approval each new ARB must demonstrate safety and efficacy independently, usually through Phase II and III trials.

The FDA does not approve based on novelty alone, but based on benefit-risk profiles shown in different patient populations.

The issue of Evergreening refers to extending patent life or market exclusivity by making minor modifications (like salts, isomers, new dosing forms).
Yes, this is a real and often criticized practice, especially when the clinical benefit of the “new” drug is marginal or not clearly better.Companies use this tactic to block generic competition and extend monopoly pricing.Examples in ARBs:Olmesartan was developed and launched after Losartan and Valsartan.
While some studies suggest differences in blood pressure control or metabolic effects, the overall therapeutic impact is often similar.

The different versions of the same class of the drugs can cause:
A)Prescribing confusion (especially in busy or rural settings)
B)Therapeutic duplication
C)Cost variations with no added benefit
D)Brand loyalty over evidence-based practice

Unfortunately FDA cannot prevent it as FDA’s role is not to evaluate patent strategy but just check safety and efficacy.The U.S. Patent Office grants patents based on novelty and non-obviousness, not clinical superiority.
Until legislation addresses evergreening more directly, the system allows multiple similar drugs for the same indication.

Still Comparative effectiveness trials could be required to prove superiority over existing options.More transparent labeling showing how new drugs differ from older ones.
Also Stronger post-market surveillance to flag drugs with unjustified high cost and minimal added benefit.
Kindly give your opinion on the subject.
Regards,
JAKSTAR PHARMA