Paracetamol caféine — Competitive Intelligence Brief

Paracetamol caféine (Paracetamol caféine) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Analgesic/antipyretic combination. Area: Pain Management.

phase 3 Analgesic/antipyretic combination Cyclooxygenase (COX), adenosine receptors Pain Management Small molecule

Target snapshot

Paracetamol caféine (Paracetamol caféine) — University of Monastir. Paracetamol reduces pain and fever by inhibiting prostaglandin synthesis in the central nervous system, while caffeine enhances analgesic efficacy and increases alertness.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Paracetamol caféine TARGET	Paracetamol caféine	University of Monastir	phase 3	Analgesic/antipyretic combination	Cyclooxygenase (COX), adenosine receptors
Acetaminophen and Ibuprofen	Acetaminophen and Ibuprofen	University of Manitoba	marketed	Analgesic/Antipyretic combination (NSAID + non-NSAID)	Prostaglandin synthesis pathway; COX-1/COX-2 enzymes
Ibuprofen/acetaminophen	Ibuprofen/acetaminophen	Montefiore Medical Center	marketed	Analgesic/antipyretic combination (NSAID + non-NSAID analgesic)	Cyclooxygenase (COX-1, COX-2) for ibuprofen; prostaglandin synthesis and central pain pathways for acetaminophen
Acetaminophen/Ibuprofen	Acetaminophen/Ibuprofen	Seoul National University Hospital	marketed	Analgesic/Antipyretic combination (NSAID + non-NSAID)	Cyclooxygenase-1 (COX-1), Cyclooxygenase-2 (COX-2), prostaglandin synthesis pathways
Paracetamol + ibuprofen	Paracetamol + ibuprofen	Ullevaal University Hospital	marketed	Analgesic/antipyretic combination	COX-1, COX-2 (ibuprofen); prostaglandin synthesis pathway (paracetamol)
Tylenol and Ibuprofen only	Tylenol and Ibuprofen only	The Cooper Health System	marketed	Analgesic/Antipyretic combination (acetaminophen + NSAID)	Prostaglandin synthesis pathway; COX-1 and COX-2 enzymes
Buscopan® Composto association	Buscopan® Composto association	EMS	phase 3	Anticholinergic agent + analgesic/antipyretic combination	Muscarinic acetylcholine receptors (hyoscine component)

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 (Analgesic/antipyretic combination class)

1. Ullevaal University Hospital · 1 drug in this class
2. University of Monastir · 1 drug in this class