Data / Drug companies / Paliperidone palmitate
Paliperidone palmitate: 2 companies and 17 products in the FDA NDC directory
Paliperidone palmitate is listed in the FDA National Drug Code Directory by 2 companies, with 17 products in commercial distribution. 0 of the products (0.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection; injection, suspension, extended release, and the newest product started marketing on December 10, 2024.
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- Companies listing it
- 2
- Products
- 17
- Generic (ANDA) products
- 0 (0.0%)
- Application numbers
- 3
- Routes
- Intramuscular
- Brand names
- Erzofri Extended-Release, Invega Sustenna, Invega Trinza, Invega Hafyera
- openFDA record search
- api.fda.gov
Companies that list paliperidone palmitate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Janssen Pharmaceuticals, Inc. | 11 | injection, suspension, extended release; injection | New drug applications (NDA) | August 30, 2021 |
| Shandong Luye Pharmaceutical Co., Ltd. | 6 | injection | New drug applications (NDA) | December 10, 2024 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection | 11 | 64.7% |
| Injection, suspension, extended release | 6 | 35.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| New drug applications (NDA) | 17 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Atypical Antipsychotic | 17 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.