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: Orphan Drug Exclusivity | Mar 5, 1998 | Orphan Designation: Treatment of neutropenia associated with bone marrow transplant, for the treatment of graft failure and delay of engraftment, and for the promotion of early engraftment. |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 15, 2002 | Orphan Designation: To reduce neutropenia and leukopenia and decrease the incidence of death due to infection in patients with acute myelogenous leukemia. Approved Labeled Indication: Following induction chemotherapy in older adult patients with acute myelogenous leukemia to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death. |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 29, 2025 | Orphan Designation: Treatment of individuals acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome) Approved Labeled Indication: LEUKINE is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]). Exclusivity Protected Indication: to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]) |
Pharmacia & Upjohn Company LLC
Genotropin (For Injection) (Subcutaneous) somatropin
NDA Applicant: Pharmacia & Upjohn Company LLC BLA No.: 020280 Prod. No.: 002 Rx (5MG); 003 Rx (0.6MG); 004 Rx (0.2MG); 005 Rx (0.8MG); 006 Rx (0.4MG); 007 Rx (12MG); 008 Rx (1MG); 009 Rx (1.2MG); 010 Rx (1.4MG); 011 Rx (1.6MG); 012 Rx (1.8MG); 013 Rx (2MG) BLA No.: 020280 Prod. No.: 001 Disc (1.5MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 31, 2004 | Orphan Designation: Treatment of adults with growth hormone deficiency. |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 20, 2007 | Orphan Designation: Treatment of short stature in patients with Prader-Willi syndrome. Approved Labeled Indication: Long-term treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS). |
| Exclusivity Type: Orphan Drug Exclusivity | Jul 25, 2008 | Orphan Designation: Treatment of growth failure in children who were born small for gestational age. Approved Labeled Indication: For long-term treatment of growth failure in children born small for gestational age who fail to manifest catch-up growth by two years of age. |
Pharmacia & Upjohn Company LLC
Somavert (For Injection) (Subcutaneous) pegvisomant
NDA Applicant: Pharmacia & Upjohn Company LLC BLA No.: 021106 Prod. No.: 001 Rx (10MG); 002 Rx (15MG); 003 Rx (20MG); 004 Rx (25MG); 005 Rx (30MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 25, 2010 | Orphan Designation: Treatment of acromegaly. Approved Labeled Indication: Treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapies, or for whom these therapies are not appropriate |
PharmaEssentia Corporation
Besremi (Injection) (Subcutaneous) ropeginterferon alfa-2b-njft
NDA Applicant: PharmaEssentia Corporation BLA No.: 761166 Prod. No.: 001 Rx (500MCG/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 12, 2028 | Orphan Designation: Treatment of polycythemia vera Approved Labeled Indication: Treatment of adults with polycythemia vera Exclusivity Protected Indication: Treatment of adults with polycythemia vera |
Pharming Americas BV
Ruconest (For Injection) (Intravenous) C1 Esterase Inhibitor (Recombinant)
NDA Applicant: Pharming Americas BV BLA No.: 125495 Prod. No.: 001 Rx (2100IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jul 16, 2021 | Orphan Designation: Treatment of (acute attacks of) angioedema caused by hereditary or acquired C1-esterase inhibitor deficiency. Approved Labeled Indication: Treatment of acute attacks of hereditary angioedema (HAE) in adult and adolescent patients. Exclusivity Protected Indication: Treatment of acute attacks of hereditary angioedema (HAE) in adult and adolescent patients. |
| Exclusivity Type: Ref. Product Exclusivity | Jul 16, 2026 |
ProMetic BioTherapeutics, Inc.
Ryplazim (For Injection) (Intravenous) plasminogen, human-tvmh
NDA Applicant: ProMetic BioTherapeutics, Inc. BLA No.: 125659 Prod. No.: 001 Rx (68.8MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 4, 2028 | Orphan Designation: Treatment of hypoplasminogenemia, or type I plasminogen deficiency Approved Labeled Indication: Treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia). Exclusivity Protected Indication: Treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia) |
| Exclusivity Type: Ref. Product Exclusivity | Jun 4, 2033 |
Protein Sciences Corporation
Flublok (Injection) (Intramuscular) Influenza Vaccine
NDA Applicant: Protein Sciences Corporation BLA No.: 125285 Prod. No.: 002 Rx (180UG/.5ML) BLA No.: 125285 Prod. No.: 001 Disc (135UG/.5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | Jan 16, 2025 |