Register entry
- Registered sites
- 0
- Active NDC listings
- 8
- Live patents
- 12
- Exclusivities
- 1
- Countries
- 0
Catalogue
Drug listings by form and route
88 active NDC listings: 8 human prescription drug. By marketing category: NDA 6, BLA 2.
| Dosage form | NDCs |
|---|---|
| injection | 3 |
| injection, powder, lyophilized, for solution | 3 |
| kit | 1 |
| ointment | 1 |
| Route | NDCs |
|---|---|
| intravenous | 5 |
| subcutaneous | 1 |
| topical | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| acrotech biopharma inc | 8 |
Exclusivity
Patents and exclusivities
12| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8835501 | BELEODAQbelinostat | product | Oct 2027 |
| RE46792 | ADQUEYdifamilast | substance, product | Mar 2028 |
| 8410077 | EVOMELAmelphalan hydrochloride | product | Mar 2029 |
| 9200088 | EVOMELAmelphalan hydrochloride | product | Mar 2029 |
| 10864183 | EVOMELAmelphalan hydrochloride | product | May 2030 |
| 11020363 | EVOMELAmelphalan hydrochloride | product | May 2030 |
| 10940128 | EVOMELAmelphalan hydrochloride | product | Jun 2030 |
| 9493582 | EVOMELAmelphalan hydrochloride | product | Feb 2033 |
| 10040872 | EVOMELAmelphalan hydrochloride | product | Jan 2034 |
| 10588893 | ADQUEYdifamilast | substance, product | Dec 2036 |
| 11541012 | KHAPZORYlevoleucovorin | product | Mar 2039 |
| Product | Exclusivity | Until |
|---|---|---|
| ADQUEYDIFAMILAST | NCE New chemical entity | Feb 2031 |
Catalogue
Marketed products
8| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ADQUEY | Difamilast | ointment, topical | 72893-017NDA |
| Beleodaq | Belinostat | injection, powder, lyophilized, for solution, intravenous | 72893-002NDA |
| EVOMELA | Melphalan | injection, powder, lyophilized, for solution, intravenous | 72893-001NDA |
| Folotyn | pralatrexate | injection, intravenous | 72893-003NDA |
| Folotyn | pralatrexate | injection, intravenous | 72893-005NDA |
| KHAPZORY | levoleucovorin | injection, powder, lyophilized, for solution, intravenous | 72893-004NDA |
| RYZNEUTA | efbemalenograstim alfa-vuxw | injection, subcutaneous | 72893-016BLA |
| Zevalin | ibritumomab tiuxetan | kit | 72893-007BLA |
Enquiry
Common questions
- Is Acrotech Biopharma Inc FDA approved?
- Acrotech Biopharma Inc holds no registered establishment of its own; 8 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does Acrotech Biopharma Inc make?
- 8 products are listed under Acrotech Biopharma Inc in the openFDA NDC Directory, most often as injection; injection, powder, lyophilized, for solution; kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.