Prescription medicine
Pivmecillinam Brand names: Pivya
Pivmecillinam (Pivya) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the pivmecillinam FDA label on DailyMed (effective October 10, 2025, Alembic Pharmaceuticals Inc.); the NDA 216483 record on Drugs@FDA; every pivmecillinam label on DailyMed.
Highlights of the record
FDA label of October 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageINDICATIONS AND USAGE PIVYA is a penicillin class antibacterial indicated for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
Forms and strengths
- 185 mg
Coated tablet.
On the market
- Earliest approval on file
- April 24, 2024 Pivya, Alembic Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 188 through July 30, 2026
What is pivmecillinam used for?
From the label: indications and usageINDICATIONS AND USAGE PIVYA is a penicillin class antibacterial indicated for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of PIVYA and other antibacterial drugs, PIVYA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. […]
Conditions named in the indications of pivmecillinam's FDA labels, with every medicine labeled for each:
From other pivmecillinam labelsUrinary tract infections: Uncomplicated Urinary Tract Infections PIVYA is indicated for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli (E. …
Source: FDA drug label (PIVYA), Alembic Pharmaceuticals Inc., effective October 10, 2025 (SPL set 440a5f17-ab11-0fc8-e063-6394a90a58e9), via openFDA; the full label on DailyMed
Is there a generic for pivmecillinam (Pivya)?
No generic pivmecillinam is approved (Drugs@FDA, October 8, 2026).
- 2024 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the pivmecillinam label say about other medicines?
The pivmecillinam label names 3 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Divalproex | drug interactions | DRUG INTERACTIONS 7.1 Other Pivalate-Generating Drugs Avoid concurrent treatment with valproic acid, valproate, or other pivalate-generating drugs. |
| Methotrexate | drug interactions | Clearance of methotrexate from the body can be reduced by concurrent use of drugs in the penicillin class, including PIVYA. Where possible, consider alternative therapy. |
| Valproic acid | drug interactions | DRUG INTERACTIONS 7.1 Other Pivalate-Generating Drugs Avoid concurrent treatment with valproic acid, valproate, or other pivalate-generating drugs. |
Source: FDA drug label (PIVYA), Alembic Pharmaceuticals Inc., effective October 10, 2025 (SPL set 440a5f17-ab11-0fc8-e063-6394a90a58e9), via openFDA; the full label on DailyMed
What do FAERS reports show for pivmecillinam?
The FDA Adverse Event Reporting System holds 188 reports that list pivmecillinam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 19 are coded as a death and 84 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.
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 pivmecillinam?
9 other medicines are given the same way (oral) and in the same FDA class as pivmecillinam or labeled mainly for the same use (urinary tract infections), the same class first. Urinary tract infections lists all 39 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 |
|---|---|---|---|---|
| Doxycycline | Urinary tract infections | 71 labelers | $0.118 per tablet 100 mg tablet | A presentation being discontinued |
| Amoxicillin and clavulanate | Urinary tract infections | 31 labelers | $0.0693 per mL 600-42.9 mg/5 mL sus | No current entry |
| Nitrofurantoin | Urinary tract infections | 47 labelers | $0.165 per capsule 50 mg capsule | A presentation being discontinued |
| Minocycline | Urinary tract infections | 21 labelers | $0.343 per capsule 100 mg capsule | No current entry |
| Methenamine | Urinary tract infections | 10 labelers | $0.313 per tablet 1 g tablet | No current entry |
| Fosfomycin | Urinary tract infections | 10 labelers | $26.22 per unit 3 g sachet | No current entry |
| Sulfadiazine | Urinary tract infections | 2 labelers | $15.06 per tablet 500 mg tablet | No current entry |
| Gepotidacin | Urinary tract infections | none listed | $91.40 per tablet 750 mg tablet | No current entry |
Every medicine labeled for the same conditions as pivmecillinam
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to pivmecillinam
- 9 medicines for the same use
- Pivmecillinam side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other