The fact that generics can launch before treatment patents expire can seem counterintuitive, but it boils down to the interplay of different patent types and legal strategies used by both brand-name and generic drug companies. Here's why and how it happens, with some specific examples:
Why generics can launch before treatment patent expiry:
- Hatch-Waxman Act and Patent Challenges:
The Hatch-Waxman Act in the US allows generic companies to challenge the validity of existing patents, including drug, formulation, and treatment patents. If they successfully convince the FDA or a court that a specific patent is invalid or not infringed, they can launch their generic version before that patent expires, even if the treatment patent remains active.
- Patent Settlements and Risk Sharing:
Brand-name companies facing potential patent challenges often find it lucrative to reach early settlements with generic manufacturers. These agreements typically allow the generic company to enter the market before the patent expires, often with limitations like delayed launch dates or restricted market share. This approach minimizes litigation costs and ensures some continued market exclusivity for the brand-name drug.
- Regulatory Exclusivity Periods:
Certain pathways for generic drug approval, like the "505(b)(2)" pathway, offer exclusive marketing rights to the first-approved generic version for a limited period, even if no patents are directly involved. This period, typically 3-6 years, gives the first generic entrant a temporary monopoly advantage before other generics arrive.
- Complex Patent Portfolios and Manufacturing Hurdles:
While drug patents cover the active ingredient itself, formulation patents protect the specific way the drug is delivered (e.g., tablet, capsule, etc.), and treatment patents cover the approved uses of the drug. Even if the drug patent expires, other patents in these categories might still be active, delaying generic entry. Additionally, complex manufacturing processes or specific ingredients might take time for generics to replicate, even after relevant patents expire.
20 interesting cases are listed below for review:
1. Abilify (aripiprazole)
2. Humira (adalimumab)
3. Vyvanse (lisdexamfetamine)
4. Nexium (esomeprazole)
6. Topamax (topiramate)
7. Januvia (sitagliptin)
8. Gleevec (imatinib)
9. Lyrica (pregabalin)
10. Symbicort (budesonide/formoterol)
11. Cymbalta (duloxetine)
12. Copaxone (glatiramer)
13. Remeron (mirtazapine)
14. Enbrel (etanercept)
15. Suboxone (buprenorphine/naloxone)
16. Viagra (sildenafil)
17. Procrit (epoetin alfa)
18. Zyprexa (olanzapine)
19. Tamiflu (oseltamivir)
20. Xarelto (rivaroxaban)
