Nepafenac 0.3% Oph Susp — Competitive Intelligence Brief

Nepafenac 0.3% Oph Susp (Nepafenac 0.3% Oph Susp) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nonsteroidal anti-inflammatory drug (NSAID). Area: Ophthalmology.

phase 3 Nonsteroidal anti-inflammatory drug (NSAID) COX-1, COX-2 Ophthalmology Small molecule

Target snapshot

Nepafenac 0.3% Oph Susp (Nepafenac 0.3% Oph Susp) — Actavis Inc.. Nepafenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin production and inflammation in the eye.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Nepafenac 0.3% Oph Susp TARGET	Nepafenac 0.3% Oph Susp	Actavis Inc.	phase 3	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1, COX-2
Dexketoprofen Trometamol + Paracetamol	Dexketoprofen Trometamol + Paracetamol	Yuzuncu Yil University	marketed	NSAID + analgesic combination	COX-1, COX-2 (dexketoprofen); central prostaglandin synthesis and pain pathways (paracetamol)
naproxen sodium codein	naproxen sodium codein	Diskapi Yildirim Beyazit Education and Research Hospital	marketed	NSAID + opioid combination analgesic	COX-1, COX-2, mu opioid receptor
Codeine paracetamol	Codeine paracetamol	Napp Pharmaceuticals Limited	marketed	Opioid analgesic combination	Opioid receptors (μ, δ, κ); cyclooxygenase (COX-1, COX-2)
Ibuprofen 2%	Ibuprofen 2%	Berlin-Chemie AG Menarini Group	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1, COX-2
Ginger-ibuprofen	Ginger-ibuprofen	Ferrosan AS	marketed	NSAID with herbal adjunct	COX-1, COX-2 (ibuprofen component); multiple inflammatory pathways (ginger component)
NSAID (Aceclofenac)	NSAID (Aceclofenac)	Dong-A ST Co., Ltd.	marketed	NSAID (nonsteroidal anti-inflammatory drug)	COX-1, 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