Tradenames starting with "H"

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.


Haegarda (For Injection) (Subcutaneous) C1 Esterase Inhibitor Subcutaneous (Human)
Drug Classes: Immunological Agents:Angioedema Agents
NDA Applicant: CSL Behring GmbH      BLA No.: 125606  Prod. No.: 001 Rx (2000IU); 002 Rx (3000IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 22, 2024Orphan Designation: Prevention and/or treatment of acute attacks of hereditary angioedema.
Approved Labeled Indication: For routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.
Exclusivity Protected Indication: For routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.

Helixate Fs, Kogenate, Kogenate Fs (For Injection) (Intravenous) Antihemophilic Factor (Recombinant)
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human antihemophilic factor
NDA Applicant: Bayer HealthCare LLC      BLA No.: 103332  Prod. No.: 001 Rx (250IU); 002 Rx (500IU); 003 Rx (1000IU); 004 Rx (2000IU); 005 Rx (3000IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 25, 2000Orphan 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.

Hemlibra (Injection) (Subcutaneous) emicizumab-kxwh
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement
NDA Applicant: Genentech, Inc.      BLA No.: 761083  Prod. No.: 001 Rx (30MG/ML); 002 Rx (60MG/0.4ML); 003 Rx (105MG/0.7ML); 004 Rx (150MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 16, 2024Orphan Designation: Treatment of hemophilia A
Approved Labeled Indication: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors
Exclusivity Protected Indication: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors
Exclusivity Type: Orphan Drug ExclusivityOct 4, 2025Orphan Designation: Treatment of hemophilia A
Approved Labeled Indication: HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.
Exclusivity Protected Indication: HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors.

Hepagam B (Injection) (Intramuscular) Hepatitis B Immune Globulin (Human)
Drug Classes: Immunological Agents:Immunoglobulins == Immunological Agents:Vaccines
NDA Applicant: Kamada Ltd.      BLA No.: 125035  Prod. No.: 001 Rx (>1560IU/5ML); 002 Rx (>312IU/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 6, 2014Orphan Designation: Prevention of hepatitis B recurrence following orthotopic liver transplant
Approved Labeled Indication: Prevention of hepatitis B recurrence following liver transplantation in HBsAG-positive liver transplant patients

Herceptin (For Injection) (Intravenous) trastuzumab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == HER2/neu receptor antagonist
NDA Applicant: Genentech, Inc.      BLA No.: 103792  Prod. No.: 002 Rx (150MG) BLA No.: 103792  Prod. No.: 001 Disc (420MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 20, 2017Orphan Designation: Treatment of HER2-overexpressing advanced adenocarcinoma of the stomach, including gastroesophageal junction
Approved Labeled Indication: Treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease

Hizentra (Injection) (Subcutaneous) Immune Globulin Subcutaneous (Human), 20% Liquid
Drug Classes: Immunological Agents:Immunoglobulins == human immunoglobulin G
NDA Applicant: CSL Behring AG      BLA No.: 125350  Prod. No.: 001 Rx (2G); 002 Rx (1G); 003 Rx (10G); 004 Rx (4G)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 15, 2025Orphan Designation: Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)
Approved Labeled Indication: Indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment.
Exclusivity Protected Indication: Indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment

Humate-P (For Injection) (Intravenous) Antihemophilic Factor/von Willebrand Factor Complex (Human)
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human antihemophilic factor
NDA Applicant: CSL Behring GmbH      BLA No.: 103960  Prod. No.: 001 Rx (1000IU); 002 Rx (250IU); 003 Rx (500IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 1, 2006Orphan Designation: Treatment of patients with von Willebrand's disease
Approved Labeled Indication: (1) In adult patients for treatment and prevention of bleeding in hemophilia A (classic hemophilia) and (2) in adult and pediatric patients for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease, and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate.

Humatrope (For Injection) (Subcutaneous) somatropin
Drug Classes: Gastrointestinal Agents:Gastrointestinal Agents, Other == Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary) == recombinant human growth hormone
NDA Applicant: Eli Lilly and Company      BLA No.: 019640  Prod. No.: 004 Rx (5MG); 005 Rx (6MG); 006 Rx (12MG); 007 Rx (24MG) BLA No.: 019640  Prod. No.: 001 Disc (2MG)
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

Humira (Injection) (Subcutaneous) adalimumab
Drug Classes: Immunological Agents:Immunosuppressants
NDA Applicant: AbbVie Inc.      BLA No.: 125057  Prod. No.: 001 Rx (40MG/0.8ML); 002 Rx (40MG/0.8ML); 004 Rx (40MG/0.8ML); 006 Rx (40MG/0.4ML); 007 Rx (40MG/0.4ML); 008 Rx (80MG/0.8ML); 009 Rx (80MG/0.8ML); 010 Rx (20MG/0.2ML); 011 Rx (10MG/0.1ML) BLA No.: 125057  Prod. No.: 003 Disc (20MG/0.4ML); 005 Disc (10MG/0.2ML)
PatentsExpirationPatented Use
Pat. No. 6805686 Autoinjector with extendable needle protector shroud
Claim Types: Device; Method of administration
Pat. Sub. Date(s): None
May 6, 2023 
Pat. No. 8231876 Purified antibody composition
Claim Types: Product-by-process; Drug in a container
Pat. Sub. Date(s): None
Apr 4, 2027 
Pat. No. 8420081 Antibody formulations and methods of making same
Claim Types: Formulation; Product-by-process; Device; Drug in a container; Process
Pat. Sub. Date(s): None
Jan 13, 2030 
Pat. No. 8663945 Methods of producing anti-TNF-alpha antibodies in mammalian cell culture
Claim Types: Process
Pat. Sub. Date(s): None
Sep 13, 2027 
Pat. No. 8708968 Removal of needle shields from syringes and automatic injection devices
Claim Types: Device
Pat. Sub. Date(s): None
Jan 24, 2032 
Pat. No. 8715664 Use of human TNF.alpha. antibodies for treatment of erosive polyarthritis
Claim Types: Method of use
Pat. Sub. Date(s): None
Jul 24, 2027 
Pat. No. 8808700 Use of TNF alpha inhibitor for treatment of erosive polyarthritis
Claim Types: Method of use
Pat. Sub. Date(s): None
May 16, 2026 
Pat. No. 8883156 Purified antibody composition
Claim Types: Method of use
Pat. Sub. Date(s): None
Apr 4, 2027 
Pat. No. 8889136 Multiple-variable dose regimen for treating TNF.alpha.-related disorders
Claim Types: Dosaage regimen
Pat. Sub. Date(s): None
Oct 9, 2027 
Pat. No. 8895009 Purified antibody composition
Claim Types: Formulation
Pat. Sub. Date(s): None
Apr 4, 2027 
Pat. No. 8906372 Purified antibody composition
Claim Types: Method of use
Pat. Sub. Date(s): None
Apr 4, 2027 
Pat. No. 8906373 Use of TNF-alpha inhibitor for treatment of psoriasis
Claim Types: Method of use
Pat. Sub. Date(s): None
Jul 18, 2023 
Pat. No. 8906646 Fed-batch method of making human anti-TNF-alpha antibody
Claim Types: Process
Pat. Sub. Date(s): None
Sep 13, 2027 
Pat. No. 8911737 Methods of administering anti-TNF.alpha. antibodies
Claim Types: Method of use
Pat. Sub. Date(s): None
Jun 5, 2022 
Pat. No. 8911964 Fed-batch method of making human anti-TNF-alpha antibody
Claim Types: Process
Pat. Sub. Date(s): None
Sep 13, 2027 
Pat. No. 8916153 Purified antibody composition
Claim Types: Composition
Pat. Sub. Date(s): None
Apr 4, 2027 
Pat. No. 8926975 Method of treating ankylosing spondylitis
Claim Types: Method of use
Pat. Sub. Date(s): None
Jun 8, 2027 
Pat. No. 8961973 Multiple-variable dose regimen for treating TNF.alpha.-related disorders
Claim Types: Dosaage regimen
Pat. Sub. Date(s): None
Apr 11, 2025 
Pat. No. 8961974 Multiple-variable dose regimen for treating TNF.alpha.-related disorders
Claim Types: Dosaage regimen
Pat. Sub. Date(s): None
Apr 11, 2025 
Pat. No. 8974790 Methods of administering anti-TNF.alpha. antibodies
Claim Types: Dosaage regimen
Pat. Sub. Date(s): None
Jun 5, 2022 
Pat. No. 8986693 Use of TNF.alpha. inhibitor for treatment of psoriasis
Claim Types: Dosaage regimen
Pat. Sub. Date(s): None
Apr 11, 2025 
Pat. No. 8992926 Methods of administering anti-TNF.alpha. antibodies
Claim Types: Dosaage regimen
Pat. Sub. Date(s): None
Jun 5, 2022 
Pat. No. 8999337 Methods for treating juvenile idiopathic arthritis by inhibition of TNF.alpha.
Claim Types: Method of use
Pat. Sub. Date(s): None
Feb 6, 2031 
Pat. No. 9061005 Multiple-variable dose regimen for treating idiopathic inflammatory bowel disease
Claim Types: Dosaage regimen
Pat. Sub. Date(s): None
Apr 11, 2025 
Pat. No. 9062106 Methods for controlling the galactosylation profile of recombinantly-expressed proteins
Claim Types: Process
Pat. Sub. Date(s): None
Apr 26, 2032 
Pat. No. 9067992 Use of TNF.alpha. inhibitor for treatment of psoriatic arthritis
Claim Types: Method of use
Pat. Sub. Date(s): None
Jul 18, 2023 
Pat. No. 9085618 Low acidic species compositions and methods for producing and using the same
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): None
Mar 14, 2033 
Pat. No. 9085619 Anti-TNF antibody formulations
Claim Types: Composition; Formulation
Pat. Sub. Date(s): None
Nov 28, 2028 
Pat. No. 9085620 Use of TNF.alpha. inhibitor for treatment of psoriatic arthritis
Claim Types: Method of administration; Process
Pat. Sub. Date(s): None
Jul 18, 2023 
Pat. No. 9090688 Methods for controlling the galactosylation profile of recombinantly-expressed proteins
Claim Types: Process
Pat. Sub. Date(s): None
Apr 26, 2032 
Pat. No. 9090689 Use of TNF.alpha. inhibitor for treatment of psoriasis
Claim Types: Method of administration; Process
Pat. Sub. Date(s): None
Jul 18, 2023 
Pat. No. 9090867 Fed-batch method of making anti-TNF-alpha antibody
Claim Types: Process
Pat. Sub. Date(s): None
Sep 13, 2027 
Pat. No. 9096666 Purified antibody composition
Claim Types: Formulation
Pat. Sub. Date(s): None
Apr 4, 2027 
Pat. No. 9102723 Purified antibody composition
Claim Types: Process; Product-by-process; Method of use
Pat. Sub. Date(s): None
Apr 4, 2027 
Pat. No. 9150645 Cell culture methods to reduce acidic species
Claim Types: Process
Pat. Sub. Date(s): None
May 13, 2033 
Pat. No. 9181337 Modulated lysine variant species compositions and methods for producing and using the same
Claim Types: Formulation
Pat. Sub. Date(s): None
Mar 14, 2033 
Pat. No. 9181572 Methods to modulate lysine variant distribution
Claim Types: Process
Pat. Sub. Date(s): None
Mar 14, 2033 
Pat. No. 9187559 Multiple-variable dose regimen for treating idiopathic inflammatory bowel disease
Claim Types: Dosaage regimen
Pat. Sub. Date(s): None
Apr 11, 2025 
Pat. No. 9234032 Fed-batch methods for producing adalimumab
Claim Types: Process
Pat. Sub. Date(s): None
Sep 13, 2027 
Pat. No. 9266949 Low acidic species compositions and methods for producing and using the same
Claim Types: Process
Pat. Sub. Date(s): None
May 13, 2033 
Pat. No. 9273132 Purified antibody composition
Claim Types: Method of use
Pat. Sub. Date(s): None
Apr 4, 2027 
Pat. No. 9284370 Methods for treating juvenile idiopathic arthritis
Claim Types: Method of use
Pat. Sub. Date(s): None
Jun 10, 2028 
Pat. No. 9284371 Methods of producing adalimumab
Claim Types: Process
Pat. Sub. Date(s): None
Sep 13, 2027 
Pat. No. 9290568 Methods to control protein heterogeneity
Claim Types: Process
Pat. Sub. Date(s): None
Mar 14, 2033 
Pat. No. 9315574 Low acidic species compositions and methods for producing and using the same
Claim Types: Process
Pat. Sub. Date(s): None
Apr 21, 2033 
Pat. No. 9328165 Purified antibody composition
Claim Types: Formulation
Pat. Sub. Date(s): None
Apr 4, 2027 
Pat. No. 9334319 Low acidic species compositions
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): None
Mar 14, 2033 
Pat. No. 9339610 Removal of needle shield from syringes and automatic injection devices
Claim Types: Device
Pat. Sub. Date(s): None
Jan 24, 2032 
Pat. No. 9346879 Protein purification methods to reduce acidic species
Claim Types: Process
Pat. Sub. Date(s): None
Mar 14, 2033 
Pat. No. 9359434 Cell culture methods to reduce acidic species
Claim Types: Process
Pat. Sub. Date(s): None
Mar 14, 2033 
Pat. No. 9499614 Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosaccharides
Claim Types: Process
Pat. Sub. Date(s): None
Mar 14, 2034 
Pat. No. 9499616 Modulated lysine variant species compositions and methods for producing and using the same
Claim Types: Process
Pat. Sub. Date(s): None
Mar 14, 2033 
Pat. No. 9505834 Methods for controlling the galactosylation profile of recombinantly-expressed proteins
Claim Types: Process
Pat. Sub. Date(s): None
Apr 26, 2032 
Pat. No. 9512216 Use of TNF.alpha. inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): None
Apr 11, 2025 
Pat. No. 9522953 Low acidic species compositions and methods for producing and using the same
Claim Types: Drug in a container; Method of use
Pat. Sub. Date(s): None
Apr 26, 2032 
Pat. No. 9546212 Methods of administering anti-TNF.alpha. antibodies
Claim Types: Method of use
Pat. Sub. Date(s): None
Jun 5, 2022 
Pat. No. 9550826 Glycoengineered binding protein compositions
Claim Types: Formulation
Pat. Sub. Date(s): None
Nov 14, 2034 
Pat. No. 9624295 Uses and compositions for treatment of psoriatic arthritis
Claim Types: Method of use
Pat. Sub. Date(s): None
Mar 31, 2031 
Pat. No. 9669093 Methods for treating juvenile idiopathic arthritis
Claim Types: Method of use
Pat. Sub. Date(s): None
Jun 10, 2028 
Pat. No. 9683033 Cell culture methods to reduce acidic species
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): None
Apr 26, 2032 
Pat. No. 9708400 Methods to modulate lysine variant distribution
Claim Types: Formulation
Pat. Sub. Date(s): None
Mar 14, 2033 
Pat. No. 9913902 Purified antibody composition
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): None
Apr 4, 2027 
Pat. No. 9957318 Protein purification methods to reduce acidic species
Claim Types: Process
Pat. Sub. Date(s): None
Apr 26, 2032 
Pat. No. 11083792 Purified antibody composition
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): None
Apr 4, 2027 
Pat. No. 11167030 Protein formulations and methods of making same
Claim Types: Formulation
Pat. Sub. Date(s): None
Nov 28, 2028 
Pat. No. 11191834 Protein formulations and methods of making same
Claim Types: Formulation
Pat. Sub. Date(s): None
Nov 28, 2028 
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 21, 2015Orphan Designation: Treatment of juvenile rheumatoid arthritis
Approved Labeled Indication: Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older.
Exclusivity Type: Orphan Drug ExclusivitySep 23, 2021Orphan Designation: Treatment of pediatric Crohn's disease
Approved Labeled Indication: Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.
Exclusivity Protected Indication: Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 through 16 years of age with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.
Exclusivity Type: Orphan Drug ExclusivitySep 30, 2021Orphan Designation: Treatment of juvenile rheumatoid arthritis
Approved Labeled Indication: Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
Exclusivity Protected Indication: Treatment of polyarticular juvenile idiopathic arthritis in patients 2 to less than 4 years of age.
Exclusivity Type: Orphan Drug ExclusivitySep 9, 2022Orphan Designation: Treatment of moderate to severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease)
Approved Labeled Indication: Treatment of moderate to severe hidradenitis suppurativa
Exclusivity Protected Indication: Treatment of moderate to severe hidradenitis suppurativa
Exclusivity Type: Orphan Drug ExclusivityJun 30, 2023Orphan Designation: Treatment of non-infectious intermediate, posterior, or panuveitis, or chronic non-infectious anterior uveitis
Approved Labeled Indication: Indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients
Exclusivity Protected Indication: Indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients
Exclusivity Type: Orphan Drug ExclusivitySep 28, 2025Orphan Designation: Treatment of non-infectious intermediate, posterior, or panuveitis, or chronic non-infectious anterior uveitis
Approved Labeled Indication: Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older
Exclusivity Protected Indication: Treatment of non-infectious intermediate, posterior, and panuveitis in pediatric patients 2 years of age and older
Exclusivity Type: Orphan Drug ExclusivityOct 16, 2025Orphan Designation: Treatment of moderate to severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease)
Approved Labeled Indication: Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
Exclusivity Protected Indication: Treatment of moderate to severe hidradenitis suppurativa (HS) in adolescent patients 12 years of age and older.
Exclusivity Type: Orphan Drug ExclusivityFeb 24, 2028Orphan Designation: Treatment of pediatric patients with ulcerative colitis
Approved Labeled Indication: treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. Limitations of Use: The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.
Exclusivity Protected Indication: treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. Limitations of Use: The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.



Last edited: 15 November 2022
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