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When does xiidra go generic?

See the DrugPatentWatch profile for xiidra

Short answer:
As of now, Xiidra (lifitegrast) has not yet been approved as a generic and there is no firm launch date announced. The drug’s patents are still in force, and the earliest a generic could appear is when those patents expire, which is projected to be around 2028–2030—after that, the FDA would still need to approve the generic product.


Why the delay?

Factor What it means for Xiidra
Patents The original patents for lifitegrast and its ophthalmic formulation were filed in 2008–2009 and are set to expire 20 years after the earliest filing date (≈ 2028).
FDA generic pathway A generic company must file a Abbreviated New Drug Application (ANDA) and demonstrate bioequivalence. Even if a company files early, the FDA review can take 1–2 years.
Market exclusivity Even after patents expire, the brand manufacturer (Alcon/Novartis) may have other exclusivity periods (e.g., orphan drug exclusivity, pediatric exclusivity, or regulatory exclusivities) that can postpone generic entry.
Current status The generic applicant (a company that filed an ANDA in the early‑2020s) has not yet received approval. The FDA has not announced a generic approval or launch date.

What to expect in the next few years

  1. Patent Expiration (≈ 2028–2030) – The key patents protecting lifitegrast will expire around this time.
  2. FDA Review – After the generic application is filed and the patents expire, the FDA will evaluate the ANDA. If approved, the generic could be marketed.
  3. Potential Launch Window – Assuming a smooth FDA review, a generic might become available mid‑2028 to early‑2029. However, this is an estimate; delays are common in the generic approval process.

How you can stay updated

  • FDA’s Drugs@FDA portal – Search “lifitegrast” or “Xiidra” to see the latest application status.
  • Patent.gov – Check the expiration dates of the lifitegrast patents for precise dates.
  • Industry news – Pharmaceutical news outlets (e.g., FiercePharma, PharmaTimes) often report on generic approvals and launch dates.

Bottom line

  • No generic is currently available.
  • Generic launch is likely around 2028–2030, pending patent expiry and FDA approval.
  • Keep an eye on the FDA portal for any official announcements.


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