Generic names starting with "F"

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.

Factor XIII Concentrate (Human) (For Injection) (Intravenous) Corifact
NDA Applicant: CSL Behring GmbH BLA No.: 125385 Prod. No.: 001 Rx (1000-1600IU)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Feb 17, 2018	Orphan Designation: Treatment of congenital factor XIII deficiency Approved Labeled Indication: For the routine prophylactic treatment of congenital factor XIII deficiency
Exclusivity Type: Orphan Drug Exclusivity	Jan 24, 2020	Orphan Designation: Treatment of congenital factor XIII deficiency Approved Labeled Indication: Indicated for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency. Exclusivity Protected Indication: Peri-operative management of surgical bleeding in adult and pediatric patients with congenital Factor XIII deficiency.

fam-trastuzumab deruxtecan-nxki (For Injection) (Intravenous) Enhertu
NDA Applicant: Daiichi Sankyo, Inc BLA No.: 761139 Prod. No.: 001 Rx (100MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Jan 15, 2028 Orphan Designation: Treatment of gastric cancer, including gastroesophageal junction cancer
Approved Labeled Indication: treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen
Exclusivity Protected Indication: treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jan 15, 2028	Orphan Designation: Treatment of gastric cancer, including gastroesophageal junction cancer Approved Labeled Indication: treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen Exclusivity Protected Indication: treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen

Fecal Microbiota Spores (Capsule) (Oral) Vowst
NDA Applicant: Seres Therapeutics, Inc. BLA No.: 125757 Prod. No.: 001 Rx (1X10 LOG 6 AND 3X10 LOG 7CFU/TAB)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Apr 26, 2030 Orphan Designation: Treatment of recurrent Clostridium difficile infection (CDI)
Approved Labeled Indication: to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI)
Exclusivity Protected Indication: to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI)

Exclusivity Type: Ref. Product Exclusivity Apr 26, 2035

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Apr 26, 2030	Orphan Designation: Treatment of recurrent Clostridium difficile infection (CDI) Approved Labeled Indication: to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI) Exclusivity Protected Indication: to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI)
Exclusivity Type: Ref. Product Exclusivity	Apr 26, 2035

Fecal Microbiota Transplantation, Frozen Preparation (Suspension) (Rectal) Rebyota
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

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

Fibrinogen Concentrate (Human) (For Injection) (Intravenous) Riastap
NDA Applicant: CSL Behring GmbH BLA No.: 125317 Prod. No.: 001 Rx (900-1300MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Jan 16, 2016 Orphan Designation: Treatment of fibrinogen deficient patients.
Approved Labeled Indication: Treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jan 16, 2016	Orphan Designation: Treatment of fibrinogen deficient patients. Approved Labeled Indication: Treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia)

filgrastim (Injection) (Intravenous, Subcutaneous ) Neupogen
NDA Applicant: Amgen Inc. BLA No.: 103353 Prod. No.: 001 Rx (300MCG/ML); 002 Rx (480MCG/1.6ML); 003 Rx (300MCG/0.5ML); 004 Rx (480MCG/0.8ML)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Jun 15, 2001 Orphan Designation: Treatment of neutropenia associated with bone marrow transplants.
Approved Labeled Indication: Reduce the duration of neutropenia and neutropenia sequelae in patients with non-myeloid malignancies undergoing ablative chemotherapy followed by BMT.

Exclusivity Type: Orphan Drug Exclusivity Dec 19, 2001 Orphan Designation: Treatment of patients with severe chronic neutropenia (absolute neutrophil count less than 500/mm3).
Approved Labeled Indication: Treatment of patients with severe chronic neutropenia.

Exclusivity Type: Orphan Drug Exclusivity Dec 28, 2002 Orphan Designation: For use in the mobilization of peripheral blood progenitor cells for collection in patients who will receive myeloablative or myelosuppressive chemotherapy.
Approved Labeled Indication: For use in the mobilization of hematopoietic progenitor cells into the peripheral blood collection by leukapheresis.

Exclusivity Type: Orphan Drug Exclusivity Apr 2, 2005 Orphan Designation: Reduction in the duration of neutropenia, fever, antibiotic use, and hospitalization, following induction and consolidation treatment for acute myeloid leukemia.
Approved Labeled Indication: Reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with acute myeloid leukemia.

Exclusivity Type: Orphan Drug Exclusivity Mar 30, 2022 Orphan Designation: Treatment of subjects at risk of developing myelosuppression after a radiological or nuclear incident
Approved Labeled Indication: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome).
Exclusivity Protected Indication: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome).

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jun 15, 2001	Orphan Designation: Treatment of neutropenia associated with bone marrow transplants. Approved Labeled Indication: Reduce the duration of neutropenia and neutropenia sequelae in patients with non-myeloid malignancies undergoing ablative chemotherapy followed by BMT.
Exclusivity Type: Orphan Drug Exclusivity	Dec 19, 2001	Orphan Designation: Treatment of patients with severe chronic neutropenia (absolute neutrophil count less than 500/mm3). Approved Labeled Indication: Treatment of patients with severe chronic neutropenia.
Exclusivity Type: Orphan Drug Exclusivity	Dec 28, 2002	Orphan Designation: For use in the mobilization of peripheral blood progenitor cells for collection in patients who will receive myeloablative or myelosuppressive chemotherapy. Approved Labeled Indication: For use in the mobilization of hematopoietic progenitor cells into the peripheral blood collection by leukapheresis.
Exclusivity Type: Orphan Drug Exclusivity	Apr 2, 2005	Orphan Designation: Reduction in the duration of neutropenia, fever, antibiotic use, and hospitalization, following induction and consolidation treatment for acute myeloid leukemia. Approved Labeled Indication: Reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with acute myeloid leukemia.
Exclusivity Type: Orphan Drug Exclusivity	Mar 30, 2022	Orphan Designation: Treatment of subjects at risk of developing myelosuppression after a radiological or nuclear incident Approved Labeled Indication: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome). Exclusivity Protected Indication: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome).

follitropin alfa (For Injection) (Subcutaneous) Gonal-f
NDA Applicant: EMD Serono, Inc. BLA No.: 020378 Prod. No.: 004 Rx (1,050IU (600IU/ML)); 005 Rx (450IU (600IU/ML)) BLA No.: 020378 Prod. No.: 001 Disc (75IU); 002 Disc (150IU); 003 Disc (37.5IU)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity May 24, 2007 Orphan Designation: For the initiation and re-initiation of spermatogenesis in adult males with reproductive failure due to hypothalamic or pituitary dysfunction, hypogonadotropic hypogonadism. AMENDED indication 6/27/00: For the induction of spermatogenesis in men with pr
Approved Labeled Indication: For the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.