Applicant, as named in the Orange Book

Merck Sharp Dohme

Merck & Co Inc · NYSE: MRK

Company and ticker: cliffwatch mapping, checked against SEC EDGAR · SEC filings

Next listed expiry: Prevymis on 30 Aug 2031. 4 products with live protection, 2 without.

Products with listed protection

DrugEarliest generic entry
Prevymis
NDA 209939 · 2 strengths
letermovir
30 Aug 2031
exclusivity
Prevymis
NDA 209940 · 2 strengths
letermovir
28 Feb 2033
patent
Belsomra
NDA 204569 · 4 strengths
suvorexant
29 May 2033
patent
Welireg
NDA 215383
belzutifan
30 Jun 2042
patent

Recent events

  • Stromectol · Generic approved · ANDA 216808, E5 PharmaApproved 9 Mar 2026Detected 25 Oct 2026
  • Stromectol · Generic approved · ANDA 218509, Ajanta Pharma LtdApproved 7 Apr 2026Detected 25 Oct 2026
  • Belsomra · Generic tentatively approved · ANDA 219386, Hetero Labs Ltd Unit IiiTentative approval 22 Dec 2025Detected 25 Oct 2026
  • Noxafil · Generic approved · ANDA 213331, ApotexApproved 29 Jun 2026Detected 25 Oct 2026
  • Pepcid Preservative Free In Plastic Container · Generic approved · ANDA 217432, LupinApproved 12 May 2026Detected 25 Oct 2026
  • Stromectol · Generic approved · ANDA 216863, Zydus LifesciencesApproved 26 Feb 2026Detected 25 Oct 2026
  • Welireg · Exclusivity expires within 90 days I-931Exclusivity expires 14 Dec 2026Detected 24 Oct 2026
Products without listed protection (2)
DrugEarliest generic entry
Stromectol
NDA 050742
ivermectin
open now
no listed protection
Temodar
NDA 022277
temozolomide
open now
no listed protection