Applicant, as named in the Orange Book

Otsuka

Part of Otsuka

Company and ticker: cliffwatch mapping, checked against SEC EDGAR

Next listed expiry: Abilify on 2 Mar 2027. 5 products with live protection, 0 without.

Products with listed protection

DrugEarliest generic entry
Abilify
NDA 021436 · 6 strengths
aripiprazole
2 Mar 2027
patent, carve-out possible
Rexulti
NDA 205422 · 6 strengths
brexpiprazole
23 Jun 2029
patent
Jynarque
NDA 204441 · 5 strengths
tolvaptan
7 Apr 2030
patent
Samsca
NDA 022275 · 2 strengths
tolvaptan
7 Apr 2030
patent
Abilify Asimtufii
NDA 217006 · 2 strengths
aripiprazole
23 Apr 2033
patent

Recent events

  • Abilify · Generic approved · ANDA 215582, QuagenApproved 22 Oct 2025Detected 25 Oct 2026
  • Jynarque · Generic approved · ANDA 220147, Alkem Labs LtdApproved 21 Apr 2026Detected 25 Oct 2026
  • Jynarque · Generic approved · ANDA 216933, Teva Pharms IncApproved 21 Jul 2026Detected 25 Oct 2026
  • Jynarque · Generic approved · ANDA 218381, ApotexApproved 10 Nov 2025Detected 25 Oct 2026
  • Abilify · Generic approved · ANDA 216208, Aurobindo PharmaApproved 18 Feb 2026Detected 25 Oct 2026
  • Dacogen · Generic approved · ANDA 217814, Somerset Theraps LlcApproved 19 Dec 2025Detected 25 Oct 2026
  • Rexulti · Exclusivity expires within 90 days PEDExclusivity expires 10 Nov 2026Detected 24 Oct 2026
  • Rexulti · Exclusivity expires within 90 days PEDExclusivity expires 10 Nov 2026Detected 24 Oct 2026
  • Rexulti · Exclusivity expires within 90 days PEDExclusivity expires 10 Nov 2026Detected 24 Oct 2026
  • Rexulti · Exclusivity expires within 90 days PEDExclusivity expires 10 Nov 2026Detected 24 Oct 2026
  • Rexulti · Exclusivity expires within 90 days PEDExclusivity expires 10 Nov 2026Detected 24 Oct 2026
  • Rexulti · Exclusivity expires within 90 days PEDExclusivity expires 10 Nov 2026Detected 24 Oct 2026
  • Abilify · Enters 12-month window basis: patent, carve-out possibleListed date 2 Mar 2027Detected 24 Oct 2026
  • Abilify · Enters 12-month window basis: patent, carve-out possibleListed date 2 Mar 2027Detected 24 Oct 2026
  • Abilify · Enters 12-month window basis: patent, carve-out possibleListed date 2 Mar 2027Detected 24 Oct 2026
  • Abilify · Enters 12-month window basis: patent, carve-out possibleListed date 2 Mar 2027Detected 24 Oct 2026
  • Abilify · Enters 12-month window basis: patent, carve-out possibleListed date 2 Mar 2027Detected 24 Oct 2026
  • Abilify · Enters 12-month window basis: patent, carve-out possibleListed date 2 Mar 2027Detected 24 Oct 2026
  • Abilify · Enters 12-month window basis: patent, carve-out possibleListed date 2 Mar 2027Detected 24 Oct 2026
  • Abilify · Enters 12-month window basis: patent, carve-out possibleListed date 2 Mar 2027Detected 24 Oct 2026
  • Abilify · Enters 12-month window basis: patent, carve-out possibleListed date 2 Mar 2027Detected 24 Oct 2026