NAMZARIC — FDA application NDA206439
Listed sponsor: ABBVIE · ABBV company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;14MG | Prescription | AB | Yes |
| 002 | NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;28MG | Prescription | AB | Yes |
| 003 | NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;7MG | Prescription | AB | Yes |
| 004 | NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | 10MG;21MG | Prescription | AB | Yes |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 8039009 | 001 | listed patent expiry date: 2029-03-24 | U-1641 |
| Patent 8039009 | 002 | listed patent expiry date: 2029-03-24 | U-1641 |
| Patent 8039009 | 003 | listed patent expiry date: 2029-03-24 | U-1641 |
| Patent 8039009 | 004 | listed patent expiry date: 2029-03-24 | U-1641 |
| Patent 8039009 | 001 | listed patent expiry date: 2029-09-24 | pediatric extension |
| Patent 8039009 | 002 | listed patent expiry date: 2029-09-24 | pediatric extension |
| Patent 8039009 | 003 | listed patent expiry date: 2029-09-24 | pediatric extension |
| Patent 8039009 | 004 | listed patent expiry date: 2029-09-24 | pediatric extension |
| Patent 8058291 | 001 | listed patent expiry date: 2029-12-05 | U-1641 |
| Patent 8058291 | 002 | listed patent expiry date: 2029-12-05 | U-1641 |
| Patent 8058291 | 003 | listed patent expiry date: 2029-12-05 | U-1641 |
| Patent 8058291 | 004 | listed patent expiry date: 2029-12-05 | U-1641 |
Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.
Compound cross-links
- DONEPEZIL HYDROCHLORIDE · UNII 3O2T2PJ89D · lmmol compound XWAIAVWHZJNZQQ-UHFFFAOYSA-N · CHEMBL1678
- MEMANTINE HYDROCHLORIDE · UNII JY0WD0UA60 · lmmol compound LDDHMLJTFXJGPI-UHFFFAOYSA-N · CHEMBL1699
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: Large-cap biopharma
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.