MK0803, lovastatin — Competitive Intelligence Brief

MK0803, lovastatin (MK0803, lovastatin) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: HMG-CoA reductase inhibitor (statin). Area: Cardiovascular.

phase 3 HMG-CoA reductase inhibitor (statin) HMG-CoA reductase Cardiovascular Small molecule

Target snapshot

MK0803, lovastatin (MK0803, lovastatin) — Merck Sharp & Dohme LLC. Lovastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
MK0803, lovastatin TARGET	MK0803, lovastatin	Merck Sharp & Dohme LLC	phase 3	HMG-CoA reductase inhibitor (statin)	HMG-CoA reductase
Crestor	rosuvastatin	AstraZeneca	marketed	HMG-CoA reductase inhibitor (statin)	HMG-CoA reductase	2003-01-01
Lipitor	atorvastatin	Pfizer Inc.	marketed	HMG-CoA reductase inhibitor (statin)	HMG-CoA reductase	1996-12-17
Lescol	FLUVASTATIN	Novartis	marketed	HMG-CoA Reductase Inhibitor	HMG-CoA reductase	1993-01-01
FLUVASTATIN SODIUM	FLUVASTATIN SODIUM		marketed		HMG-CoA reductase	1993-01-01
Simvastatin plus ticagrelor	Simvastatin plus ticagrelor	Federal University of São Paulo	marketed	Statin plus P2Y12 receptor antagonist combination	HMG-CoA reductase; P2Y12 receptor
Berberine;Atorvastatin or Rosuvastatin	Berberine;Atorvastatin or Rosuvastatin	Wenzhou Medical University	marketed	Combination lipid-lowering agent (natural alkaloid + statin)	AMPK (berberine); HMG-CoA reductase (statin 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)

• 2037-06-07 — Lipitor · 11654106 · US
• 2037-06-07 — Lipitor · 11369567 · US

Sponsor landscape (HMG-CoA reductase inhibitor (statin) class)

1. Organon and Co · 7 drugs in this class
2. Kuhnil Pharmaceutical Co., Ltd. · 3 drugs in this class
3. Wenzhou Medical University · 2 drugs in this class
4. Amgen · 2 drugs in this class
5. Beijing Tiantan Hospital · 2 drugs in this class
6. Seoul National University Hospital · 2 drugs in this class
7. JW Pharmaceutical · 2 drugs in this class
8. AstraZeneca · 2 drugs in this class
9. Korea University Anam Hospital · 2 drugs in this class
10. Gachon University Gil Medical Center · 1 drug in this class