Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | Dec 16, 2034 |
Ferring Pharmaceuticals Inc.
Acthrel (For Injection) (Intravenous) corticorelin ovine triflutate
NDA Applicant: Ferring Pharmaceuticals Inc. BLA No.: 020162 Prod. No.: 001 Disc (100MCG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 23, 2003 | Orphan Designation: For use in differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushings syndrome. Approved Labeled Indication: To differentiate between pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing's syndrome. |
Ferring Pharmaceuticals Inc.
Rebyota (Suspension) (Rectal) Fecal Microbiota Transplantation, Frozen Preparation
NDA Applicant: Ferring Pharmaceuticals Inc. BLA No.: 125739 Prod. No.: 001 Rx (BETWEEN 1X10^8 AND 5X10^10CFU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 30, 2029 | Orphan Designation: Prevention of recurrent Clostridium difficile infection (CDI) in individuals with recurrent Clostridium difficile infection Approved Labeled Indication: prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI Exclusivity Protected Indication: prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI |
| Exclusivity Type: Ref. Product Exclusivity | Nov 30, 2034 |