Company names starting with "E"

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.

Eisai, Incorporated
Ontak (Injection) (Intravenous) denileukin diftitox
NDA Applicant: Eisai, Incorporated      BLA No.: 103767  Prod. No.: 001 Disc (150MCG/ML (300MCG/2ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 5, 2006Orphan Designation: Treatment of patients with cutaneous T-cell lymphoma
Approved Labeled Indication: Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor.

Eli Lilly and Company
Cyramza (Injection) (Intravenous) ramucirumab
NDA Applicant: Eli Lilly and Company      BLA No.: 125477  Prod. No.: 001 Rx (100MG/10ML (10MG/ML)); 002 Rx (500MG/50ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 21, 2021Orphan Designation: Treatment of gastric cancer
Approved Labeled Indication: CYRAMZA as a single-agent is indicated for the treatment of patients with advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
Exclusivity Protected Indication: Treatment of advanced gastric cancer or gastro-esophageal junction adenocarcinoma, as a single-agent after prior fluoropyrimidine-or platinum-containing therapy.
Exclusivity Type: Orphan Drug ExclusivityMay 10, 2026Orphan Designation: Treatment of hepatocellular carcinoma
Approved Labeled Indication: CYRAMZA, as a single agent, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha fetoprotein (AFP) of >=400 ng/mL and have been treated with sorafenib.
Exclusivity Protected Indication: CYRAMZA, as a single agent, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha fetoprotein (AFP) of >=400 ng/mL and have been treated with sorafenib.

Eli Lilly and Company
Erbitux (Injection) (Intravenous) cetuximab
NDA Applicant: Eli Lilly and Company      BLA No.: 125084  Prod. No.: 001 Rx (100MG/50ML (2MG/ML)); 002 Rx (200MG/100ML (2MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 1, 2013Orphan Designation: Treatment of squamous cell cancer of the head and neck in patients who express epidermal growth factor receptor
Approved Labeled Indication: For use in combination with radiation therapy, for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) and for use as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed

Eli Lilly and Company
Humatrope (For Injection) (Subcutaneous) somatropin
NDA Applicant: Eli Lilly and Company      BLA No.: 019640  Prod. No.: 005 Rx (6MG); 006 Rx (12MG); 007 Rx (24MG) BLA No.: 019640  Prod. No.: 001 Disc (2MG); 004 Disc (5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 8, 1994Orphan Designation: For the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone.
Exclusivity Type: Orphan Drug ExclusivityDec 30, 2003Orphan Designation: Treatment of short stature associated with Turner syndrome.
Approved Labeled Indication: Treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed.
Exclusivity Type: Orphan Drug ExclusivityNov 1, 2013Orphan Designation: Treatment of short stature in pediatric patients with short stature homeobox-containing gene (SHOX) deficiency
Approved Labeled Indication: Treatment of short stature or growth failure in children with SHOX (short stature homeobox-containing gene) deficiency whose epiphyses are not closed

Eli Lilly and Company
Lartruvo (Injection) (Intravenous) olaratumab
NDA Applicant: Eli Lilly and Company      BLA No.: 761038  Prod. No.: 001 Disc (500MG/50ML (10MG/ML)); 002 Disc (190MG/19ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 25, 2020Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.

Eli Lilly and Company
Portrazza (Injection) (Intravenous) necitumumab
NDA Applicant: Eli Lilly and Company      BLA No.: 125547  Prod. No.: 001 Rx (800MG/50ML (16MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 24, 2022Orphan Designation: Treatment of squamous non-small cell lung cancer
Approved Labeled Indication: Use in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic, squamous, non-small cell lung cancer. Limitation of Use: PORTRAZZA is not indicated for treatment of non-squamous non-small cell lung cancer.
Exclusivity Protected Indication: Use in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic, squamous, non-small cell lung cancer. PORTRAZZA is not indicated for treatment of non-squamous, non-small cell lung cancer

Elusys Therapeutics, Inc.
Anthim (Injection) (Intravenous) obiltoxaximab
NDA Applicant: Elusys Therapeutics, Inc.      BLA No.: 125509  Prod. No.: 001 Rx (600MG/6ML (100MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 18, 2023Orphan Designation: Treatment of exposure to B. anthracis spores
Approved Labeled Indication: Treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or are not appropriate.
Exclusivity Protected Indication: 1) Treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and (2) for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.

EMD Serono, Inc.
Bavencio (Injection) (Intravenous) avelumab
NDA Applicant: EMD Serono, Inc.      BLA No.: 761049  Prod. No.: 001 Rx (200MG/10ML (20MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 23, 2024Orphan Designation: Treatment of merkel cell carcinoma.
Approved Labeled Indication: Treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma
Exclusivity Protected Indication: Treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma

EMD Serono, Inc.
Gonal-f (For Injection) (Subcutaneous) follitropin alfa
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 24, 2007Orphan 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.

EMD Serono, Inc.
Serostim (For Injection) (Subcutaneous) somatropin
NDA Applicant: EMD Serono, Inc.      BLA No.: 020604  Prod. No.: 001 Rx (6MG); 002 Rx (5MG); 003 Rx (4MG) BLA No.: 020604  Prod. No.: 005 Disc (6MG/0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 23, 2003Orphan Designation: Treatment of AIDS-associated catabolism/weight loss.
Approved Labeled Indication: Treatment of AIDS wasting or cachexia.

Emergent BioDefense Operations Lansing LLC
Biothrax (Injection) (Intramuscular; Subcutaneous) Anthrax Vaccine Adsorbed
NDA Applicant: Emergent BioDefense Operations Lansing LLC      BLA No.: 103821  Prod. No.: 001 Rx (0.5ML); 002 Rx (0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 23, 2022Orphan Designation: For post-exposure prophylaxis of anthrax disease resulting from suspected or confirmed Bacillus anthracis exposure
Approved Labeled Indication: For post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs.
Exclusivity Protected Indication: For post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs.

Emergent BioSolutions Canada Inc.
Anthrasil (Injection) (Intravenous) Anthrax Immune Globulin Intravenous (Human)
NDA Applicant: Emergent BioSolutions Canada Inc.      BLA No.: 125562  Prod. No.: 001 Rx (>=60 U)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 24, 2022Orphan Designation: Treatment of inhalational anthrax
Approved Labeled Indication: Treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs
Exclusivity Protected Indication: Treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs

Emergent BioSolutions Canada Inc.
Bat (Solution) (Intravenous) Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)
NDA Applicant: Emergent BioSolutions Canada Inc.      BLA No.: 125462  Prod. No.: 001 Rx (>4500U)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 22, 2020Orphan Designation: Treatment of botulism.
Approved Labeled Indication: Treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin (BoNT) serotypes A, B, C, D, E, F or G in adults and pediatric patients.
Exclusivity Protected Indication: Treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients

Emergent Manufacturing Operations Baltimore LLC
Ebanga (For Injection) (Intravenous) ansuvimab-zykl
NDA Applicant: Emergent Manufacturing Operations Baltimore LLC      BLA No.: 761172  Prod. No.: 001 Rx (400MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 21, 2027Orphan Designation: Treatment of Ebola Virus Disease
Approved Labeled Indication: treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection
Exclusivity Protected Indication: treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection

Emergent Manufacturing Operations Baltimore LLC
N/A (Injection) (Intravenous) raxibacumab
NDA Applicant: Emergent Manufacturing Operations Baltimore LLC      BLA No.: 125349  Prod. No.: 001 Rx (1,700MG/34ML (50MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 14, 2019Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.

Enzyvant Therapeutics GmbH
Rethymic (For Suspension) (Implantation) allogeneic processed thymus tissue-agdc
NDA Applicant: Enzyvant Therapeutics GmbH      BLA No.: 125685  Prod. No.: 001 Rx (SEMI-QUANTITATIVE)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 8, 2028Orphan Designation: Treatment of congenital athymia
Approved Labeled Indication: immune reconstitution in pediatric patients with congenital athymia
Exclusivity Protected Indication: immune reconstitution in pediatric patients with congenital athymia
Exclusivity Type: Ref. Product ExclusivityOct 8, 2033 

EUSA Pharma (UK) Limited
Sylvant (For Injection) (Intravenous) siltuximab
NDA Applicant: EUSA Pharma (UK) Limited      BLA No.: 125496  Prod. No.: 001 Rx (100MG); 002 Rx (400MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 23, 2021Orphan Designation: Treatment of Castleman's disease
Approved Labeled Indication: Treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
Exclusivity Protected Indication: Treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.


Last edited: 19 August 2023
© 2001-2023 Bruce A. Pokras, All rights reserved worldwide