Prescription medicine
Pitavastatin Brand names: Zypitamag, Livalo
Pitavastatin (Livalo) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 12 generic labelers, and pharmacies paid $0.954 per pitavastatin 2 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the pitavastatin FDA label on DailyMed (effective March 31, 2026, Kowa Pharmaceuticals America, Inc.); the NDA 22363 record on Drugs@FDA; every pitavastatin label on DailyMed.
Highlights of the record
FDA label of March 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageLIVALO is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.
Forms and strengths
- 1 mg
- 1.045 mg
- 2 mg
- 2.09 mg
- 4 mg
- 4.18 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- August 3, 2009 Livalo, Kowa Co; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first December 20, 2016; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 12 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- January 19, 2031 Zypitamag tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.954 per tablet Pitavastatin 2 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 7 since 2021 0 Class I among all firms' recalls; latest February 3, 2026
- FAERS reports
- 10,225 through July 30, 2026
What is pitavastatin used for?
From the label: indications and usageLIVALO is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). LIVALO is a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: ( 1 ) Adults with primary hyperlipidemia. Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
Conditions named in the indications of pitavastatin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: HMG-CoA Reductase Inhibitor.
Source: FDA drug label (Livalo), Kowa Pharmaceuticals America, Inc., effective March 31, 2026 (SPL set 44dcbf97-99ec-427c-ba50-207e0069d6d2), via openFDA; the full label on DailyMed
Is there a generic for pitavastatin (Livalo)?
The FDA approved the first generic pitavastatin on December 20, 2016. 8 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists pitavastatin from 12 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Livalo tablets; a patent listed only for Zypitamag tablets runs to January 19, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2009 earliest approval on file
- 2016 first generic approved
- 2031 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for pitavastatin (Livalo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.954 per Pitavastatin 2 mg tablet, down 34% from $1.45 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Pitavastatin 2 mg tablet (generic)
- Livalo 2 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Pitavastatin 1 mg tablet | Generic | $0.904 per tablet | $27.13 | -42% |
| Pitavastatin 2 mg tablet | Generic | $0.954 per tablet | $28.63 | -34% |
| Pitavastatin 4 mg tablet | Generic | $1.03 per tablet | $30.87 | -29% |
| Livalo 1 mg tablet | Brand | $10.21 per tablet | $306.34 | no change |
| Livalo 2 mg tablet | Brand | $10.21 per tablet | $306.18 | no change |
| Livalo 4 mg tablet | Brand | $10.22 per tablet | $306.67 | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has pitavastatin been recalled?
The FDA's Enforcement Report lists 7 recalls naming pitavastatin since 2021: 0 Class I (the most serious), 1 Class II, 6 Class III; 5 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 3, 2026 | Class III | Annora Pharma Private Limited | Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg |
| June 26, 2025 | Class III | AvKARE | Failed Impurity/Degradation Specifications |
| June 11, 2025 | Class III | Orient Pharma Co., Ltd. Yunlin Plant | Failed Impurities/Degradation Specifications. |
| February 24, 2025 | Class III | Kowa Pharmaceuticals America | Presence of foreign tablets/capsules |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pitavastatin label say about other medicines?
The pitavastatin label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name pitavastatin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Colchicine | drug interactions | Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with statins, including LIVALO. Intervention: Consider the risk/benefit of concomitant use of colchicine with LIVALO. |
| Cyclosporine | contraindications | CONTRAINDICATIONS LIVALO is contraindicated in the following conditions: Concomitant use of cyclosporine [see Drug Interactions (7) ]. |
| Erythromycin | drug interactions | Clinical Impact: Erythromycin significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Intervention: In patients taking erythromycin, do not exceed LIVALO 1 mg once daily [see Dosage and Administration (2.4) ]. |
| Gemfibrozil | drug interactions | Clinical Impact: Gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of gemfibrozil with statins, including LIVALO. Intervention: Avoid concomitant use of gemfibrozil with LIVALO. |
| Niacin | drug interactions | Niacin Clinical Impact: The risk of myopathy and rhabdomyolysis may be increased with concomitant use of lipid-modifying doses (≥1 g/day) of niacin with LIVALO. Intervention: Consider if the benefit of using lipid-modifying doses (≥1 g/day) of niacin concomitantly with LIVALO outweighs the increased risk of myopathy and rhabdomyolysis. |
| Rifampin | drug interactions | Clinical Impact: Rifampin significantly increases peak pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Intervention: In patients taking rifampin, do not exceed LIVALO 2 mg once daily [see Dosage and Administration (2.4) ]. |
Other labels that name pitavastatin
Source: FDA drug label (Livalo), Kowa Pharmaceuticals America, Inc., effective March 31, 2026 (SPL set 44dcbf97-99ec-427c-ba50-207e0069d6d2), via openFDA; the full label on DailyMed
What do FAERS reports show for pitavastatin?
The FDA Adverse Event Reporting System holds 10,225 reports that list pitavastatin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,071 are coded as a death and 3,728 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as pitavastatin?
19 other medicines are given the same way (oral) and in the same FDA class as pitavastatin or labeled mainly for the same use (high cholesterol), the same class first. High cholesterol lists all 25 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Atorvastatin | High cholesterol | 61 labelers | $0.0228 per tablet 10 mg tablet | No current entry |
| Rosuvastatin | High cholesterol | 46 labelers | $0.0692 per tablet 40 mg tablet | No current entry |
| Pravastatin | High cholesterol | 37 labelers | $0.058 per tablet 20 mg tablet | No current entry |
| Simvastatin | High cholesterol | 27 labelers | $0.0321 per tablet 20 mg tablet | No current entry |
| Amlodipine and atorvastatin | High cholesterol | 6 labelers | $1.34 per unit 10-40 mg | No current entry |
| Lovastatin | High cholesterol | 19 labelers | $0.0436 per tablet 20 mg tablet | No current entry |
| Ezetimibe and simvastatin | High cholesterol | 7 labelers | $0.285 per unit 10-80 mg | No current entry |
| Fluvastatin | High cholesterol | 4 labelers | $2.88 per tablet 80 mg tablet | A presentation being discontinued |
Every medicine labeled for the same conditions as pitavastatin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does pitavastatin compare with medicines for the same use?
5 side-by-side pages set pitavastatin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to pitavastatin
- 19 medicines for the same use
- Other statins
- the pharmacologic class, with prices and generics
- Pitavastatin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other