Rectal Indomethacin — Competitive Intelligence Brief

Rectal Indomethacin (Rectal Indomethacin) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nonsteroidal anti-inflammatory drug (NSAID). Area: Rheumatology, Pain Management, Neurology.

marketed Nonsteroidal anti-inflammatory drug (NSAID) Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2) Rheumatology, Pain Management, Neurology Small molecule

Target snapshot

Rectal Indomethacin (Rectal Indomethacin) — Moti Lal Nehru Medical College. Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation, pain, and fever.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Rectal Indomethacin TARGET	Rectal Indomethacin	Moti Lal Nehru Medical College	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2)
Aspirin 80	Aspirin 80	Shiraz University of Medical Sciences	marketed	Nonsteroidal anti-inflammatory drug (NSAID); antiplatelet agent	Cyclooxygenase-1 (COX-1); Cyclooxygenase-2 (COX-2)
Loxoprofen sodium hydrogel patch	Loxoprofen sodium hydrogel patch	Sun Yat-sen University	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1 and COX-2)
Acetylsalicylic Acid (ASA)	Acetylsalicylic Acid (ASA)	Sunnybrook Health Sciences Centre	marketed	Nonsteroidal anti-inflammatory drug (NSAID); antiplatelet agent	Cyclooxygenase-1 (COX-1); Cyclooxygenase-2 (COX-2)
High Dose Ibuprofen	High Dose Ibuprofen	Ottawa Hospital Research Institute	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1 and COX-2
Aspirin monotherapy	Aspirin monotherapy	Harbin Medical University	marketed	Nonsteroidal anti-inflammatory drug (NSAID); antiplatelet agent	Cyclooxygenase-1 (COX-1); Cyclooxygenase-2 (COX-2)
Diclofenac Sodium Topical Gel, 1%	Diclofenac Sodium Topical Gel, 1%	Amneal Pharmaceuticals, LLC	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (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