Diclofenac Test (lower dose) — Competitive Intelligence Brief

Diclofenac Test (lower dose) (Diclofenac Test (lower dose)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nonsteroidal anti-inflammatory drug (NSAID). Area: Pain Management / Rheumatology.

phase 3 Nonsteroidal anti-inflammatory drug (NSAID) COX-1 and COX-2 Pain Management / Rheumatology Small molecule

Target snapshot

Diclofenac Test (lower dose) (Diclofenac Test (lower dose)) — Iroko Pharmaceuticals, LLC. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and decrease inflammation and pain.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Diclofenac Test (lower dose) TARGET	Diclofenac Test (lower dose)	Iroko Pharmaceuticals, LLC	phase 3	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1 and COX-2
Cytotec	Misoprostol	Pfizer	marketed	NSAID combined with prostaglandin analog	Cyclooxygenase (COX-1 and COX-2); Prostaglandin receptors	1988-01-01
High Dose Ibuprofen	High Dose Ibuprofen	Ottawa Hospital Research Institute	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1 and COX-2
Ibuprofen Acid	Ibuprofen Acid	Reckitt Benckiser Healthcare (UK) Limited	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1 and COX-2
Indomethacin suppository	Indomethacin suppository	Azienda USL Reggio Emilia - IRCCS	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1 and COX-2
Surgery with Naproxen	Surgery with Naproxen	Giovana Maria Weckwerth	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1 and COX-2)
Ketorolac Tromethamine 0.45%	Ketorolac Tromethamine 0.45%	Bucci Laser Vision Institute	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1 and COX-2)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Nonsteroidal anti-inflammatory drug (NSAID) class)

1. Università degli Studi di Brescia · 4 drugs in this class
2. Bausch & Lomb Incorporated · 4 drugs in this class
3. Bayer · 3 drugs in this class
4. Pfizer · 3 drugs in this class
5. Azienda USL Reggio Emilia - IRCCS · 3 drugs in this class
6. Organon and Co · 3 drugs in this class
7. Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division · 2 drugs in this class
8. Bezmialem Vakif University · 2 drugs in this class
9. Guang'anmen Hospital of China Academy of Chinese Medical Sciences · 2 drugs in this class
10. Center For Excellence In Eye Care · 2 drugs in this class