Register entry
- Registered sites
- 0
- Active NDC listings
- 6
- Live patents
- 194
- Exclusivities
- 1
- Countries
- 0
Catalogue
Drug listings by form and route
66 active NDC listings: 6 human prescription drug. By marketing category: NDA 6.
| Dosage form | NDCs |
|---|---|
| pellet | 4 |
| capsule | 2 |
| Route | NDCs |
|---|---|
| oral | 6 |
| Labeller name on the listing | NDCs |
|---|---|
| biocryst pharmaceuticals, inc. | 6 |
Exclusivity
Patents and exclusivities
194| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10391075 | RAPIVABperamivir | use | Feb 2027 |
| 8778997 | RAPIVABperamivir | use | May 2027 |
| 10329260 | ORLADEYOberotralstat dihydrochloride | substance | Mar 2035 |
| 10689346 | ORLADEYOberotralstat dihydrochloride | use | Mar 2035 |
| 11230530 | ORLADEYOberotralstat dihydrochloride | use | Mar 2035 |
| 11708333 | ORLADEYOberotralstat dihydrochloride | use | Mar 2035 |
| 12116346 | ORLADEYOberotralstat dihydrochloride | substance | Mar 2035 |
| 10125102 | ORLADEYOberotralstat dihydrochloride | substance | Apr 2035 |
| 10329260*PED | ORLADEYOberotralstat dihydrochloride | use | Sept 2035 |
| 10689346*PED | ORLADEYOberotralstat dihydrochloride | use | Sept 2035 |
| 11230530*PED | ORLADEYOberotralstat dihydrochloride | use | Sept 2035 |
| 11708333*PED | ORLADEYOberotralstat dihydrochloride | use | Sept 2035 |
| 12116346*PED | ORLADEYOberotralstat dihydrochloride | use | Sept 2035 |
| 10125102*PED | ORLADEYOberotralstat dihydrochloride | use | Oct 2035 |
| 10662160 | ORLADEYOberotralstat dihydrochloride | substance | Nov 2039 |
| 11117867 | ORLADEYOberotralstat dihydrochloride | product | Nov 2039 |
| 11618733 | ORLADEYOberotralstat dihydrochloride | use | Nov 2039 |
| 12344585 | ORLADEYOberotralstat dihydrochloride | use | Nov 2039 |
| 12545645 | ORLADEYOberotralstat dihydrochloride | substance, product | Nov 2039 |
| 12545646 | ORLADEYOberotralstat dihydrochloride | substance, product | Nov 2039 |
| 12545647 | ORLADEYOberotralstat dihydrochloride | substance, product | Nov 2039 |
| 12552750 | ORLADEYOberotralstat dihydrochloride | substance, product | Nov 2039 |
| 12590068 | ORLADEYOberotralstat dihydrochloride | substance, product | Nov 2039 |
| 12590069 | ORLADEYOberotralstat dihydrochloride | substance, product | Nov 2039 |
| 10662160*PED | ORLADEYOberotralstat dihydrochloride | use | May 2040 |
| 11117867*PED | ORLADEYOberotralstat dihydrochloride | use | May 2040 |
| 11618733*PED | ORLADEYOberotralstat dihydrochloride | use | May 2040 |
| 12344585*PED | ORLADEYOberotralstat dihydrochloride | use | May 2040 |
| 12545645*PED | ORLADEYOberotralstat dihydrochloride | use | May 2040 |
| 12545646*PED | ORLADEYOberotralstat dihydrochloride | use | May 2040 |
| 12545647*PED | ORLADEYOberotralstat dihydrochloride | use | May 2040 |
| 12552750*PED | ORLADEYOberotralstat dihydrochloride | use | May 2040 |
| 12590068*PED | ORLADEYOberotralstat dihydrochloride | use | May 2040 |
| 12590069*PED | ORLADEYOberotralstat dihydrochloride | use | May 2040 |
| Product | Exclusivity | Until |
|---|---|---|
| ORLADEYOBEROTRALSTAT DIHYDROCHLORIDE | PED Paediatric | Jun 2029 |
Catalogue
Marketed products
6| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Orladeyo | Berotralstat hydrochloride | capsule, oral | 72769-101NDA |
| Orladeyo | Berotralstat hydrochloride | capsule, oral | 72769-102NDA |
| Orladeyo | Berotralstat hydrochloride | pellet, oral | 72769-111NDA |
| Orladeyo | Berotralstat hydrochloride | pellet, oral | 72769-112NDA |
| Orladeyo | Berotralstat hydrochloride | pellet, oral | 72769-113NDA |
| Orladeyo | Berotralstat hydrochloride | pellet, oral | 72769-114NDA |
Compare
Other companies listing berotralstat hydrochloride
- Catalent Pharma Solutions Inc.22 sites · 261 NDC
- Cambrex Charles City, Inc.0 sites · 112 NDC
Enquiry
Common questions
- Is BioCryst Pharmaceuticals, Inc. FDA approved?
- BioCryst Pharmaceuticals, Inc. holds no registered establishment of its own; 6 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does BioCryst Pharmaceuticals, Inc. make?
- 6 products are listed under BioCryst Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as pellet; capsule. 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.