Register entry
Helsinn Therapeutics (U.S.), Inc.
Data as of · How to read this entry
- Registered sites
- 0
- Active NDC listings
- 4
- Live patents
- 44
- Exclusivities
- 1
- Countries
- 0
Catalogue
Drug listings by form and route
44 active NDC listings: 4 human prescription drug. By marketing category: NDA 4.
| Dosage form | NDCs |
|---|---|
| injection | 2 |
| capsule | 1 |
| gel | 1 |
| Route | NDCs |
|---|---|
| intravenous | 2 |
| oral | 1 |
| topical | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| helsinn therapeutics (u.s.), inc. | 4 |
Exclusivity
Patents and exclusivities
44| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 9067896 | TRUSELTIQinfigratinib phosphate | substance | Aug 2028 |
| 8552002 | TRUSELTIQinfigratinib phosphate | substance, product | Aug 2029 |
| 11559523 | AKYNZEOnetupitant; palonosetron hydrochloride | product | Nov 2030 |
| 12042494 | AKYNZEOnetupitant; palonosetron hydrochloride | product | Nov 2030 |
| 8623826 | AKYNZEOnetupitant; palonosetron hydrochloride | use | Nov 2030 |
| 8951969 | AKYNZEOnetupitant; palonosetron hydrochloride | product | Nov 2030 |
| 9186357 | AKYNZEOfosnetupitant chloride hydrochloride; palonosetron hydrochloride; netupitant; palonosetron hydrochloride | use | Nov 2030 |
| 9943515 | AKYNZEOnetupitant; palonosetron hydrochloride | use | Nov 2030 |
| 10828297 | AKYNZEOfosnetupitant chloride hydrochloride; palonosetron hydrochloride; netupitant; palonosetron hydrochloride | use | Dec 2030 |
| 9271975 | AKYNZEOnetupitant; palonosetron hydrochloride | use | Sept 2031 |
| 10208073 | AKYNZEOfosnetupitant chloride hydrochloride; palonosetron hydrochloride | use | May 2032 |
| 10717721 | AKYNZEOfosnetupitant chloride hydrochloride; palonosetron hydrochloride | substance | May 2032 |
| 11312698 | AKYNZEOfosnetupitant chloride hydrochloride; palonosetron hydrochloride | substance, product | May 2032 |
| 8426450 | AKYNZEOfosnetupitant chloride hydrochloride; palonosetron hydrochloride | substance, product | May 2032 |
| 8895586 | AKYNZEOfosnetupitant chloride hydrochloride; palonosetron hydrochloride | use | May 2032 |
| 9403772 | AKYNZEOfosnetupitant chloride hydrochloride; palonosetron hydrochloride | substance | May 2032 |
| 9908907 | AKYNZEOfosnetupitant chloride hydrochloride; palonosetron hydrochloride | substance, product | May 2032 |
| 10278969 | TRUSELTIQinfigratinib phosphate | product | Dec 2034 |
| 11160804 | TRUSELTIQinfigratinib phosphate | product | Dec 2034 |
| 10233154 | AKYNZEOnetupitant; palonosetron hydrochloride | substance | Sept 2035 |
| 10676440 | AKYNZEOnetupitant; palonosetron hydrochloride | substance, product | Sept 2035 |
| 10961195 | AKYNZEOnetupitant; palonosetron hydrochloride | substance, product | Sept 2035 |
| 9951016 | AKYNZEOnetupitant; palonosetron hydrochloride | substance, product | Sept 2035 |
| 10624911 | AKYNZEOfosnetupitant chloride hydrochloride; palonosetron hydrochloride | product | Jun 2037 |
| 11529362 | AKYNZEOfosnetupitant chloride hydrochloride; palonosetron hydrochloride | product | Jun 2037 |
| 12208109 | AKYNZEOfosnetupitant chloride hydrochloride; palonosetron hydrochloride | product | Jun 2037 |
| Product | Exclusivity | Until |
|---|---|---|
| TRUSELTIQINFIGRATINIB PHOSPHATE | ODE-353 Orphan drug | May 2028 |
Catalogue
Marketed products
4| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| AKYNZEO | Netupitant and Palonosetron | capsule, oral | 69639-101NDA |
| AKYNZEO | Fosnetupitant and Palonosetron | injection, intravenous | 69639-105NDA |
| AKYNZEO | Fosnetupitant and Palonosetron | injection, intravenous | 69639-106NDA |
| VALCHLOR | mechlorethamine hydrochloride | gel, topical | 69639-120NDA |
Enquiry
Common questions
- Is Helsinn Therapeutics (U.S.), Inc. FDA approved?
- Helsinn Therapeutics (U.S.), Inc. holds no registered establishment of its own; 4 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does Helsinn Therapeutics (U.S.), Inc. make?
- 4 products are listed under Helsinn Therapeutics (U.S.), Inc. in the openFDA NDC Directory, most often as injection; capsule; gel. 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.