Drug
Who makes riluzole?
7 companies list riluzole as a human prescription drug, including under the names TIGLUTIK, Teglutik. Forms: liquid; suspension; tablet; tablet, film coated. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing riluzole
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| EDW PHARMA, INC.United States | liquid | NDA, UNAPPROVED DRUG FOR USE IN DRUG SHORTAGENDA209080 | 4 | 1 |
| Sun Pharmaceutical Industries LimitedIndia | tablet, film coated | ANDAANDA091417 | 1 | 13 |
| Glenmark Pharmaceuticals Inc., USAIndia | tablet, film coated | ANDAANDA091394 | 1 | 9 |
| Italfarmaco S.A.Italy | suspension | NDANDA209080 | 1 | 2 |
| Florida Pharmaceutical Products LLCUnited States | tablet, film coated | ANDAANDA206045 | 1 | 1 |
| ASCEND Therapeutics US, LLC | tablet | ANDAANDA204048 | 1 | 0 |
| AvKARE | tablet, film coated | ANDAANDA206045 | 1 | 0 |
Bulk ingredient listings
- Alivus Life Sciences Limited · 1 NDC
- CZECH-GEN, a.s.Czechia · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Syn-Tech Chem. & Pharm. Co., Ltd.Taiwan · 1 NDC
Orange Book patents
1 unexpired patent lists riluzole as the active ingredient, expiring between Mar 2029 and Mar 2029. Application holder: ITALFARMACO SA.
Enquiry
Common questions
- Who makes riluzole?
- 7 companies list riluzole as a human prescription drug in the openFDA NDC Directory, led by EDW PHARMA, INC., Sun Pharmaceutical Industries Limited, Glenmark Pharmaceuticals Inc., USA, Italfarmaco S.A., Florida Pharmaceutical Products LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic TIGLUTIK?
- 5 companies list riluzole under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies riluzole active ingredient?
- 6 companies list riluzole as a bulk ingredient, including Alivus Life Sciences Limited, CZECH-GEN, a.s., Hetero Drugs Limited, ScinoPharm Taiwan, Ltd..