Company names starting with "H"

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.


Hoffmann-La Roche Inc.
Roferon-A (For Injection) (Subcutaneous) interferon alfa-2a
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == Immunological Agents:Immunostimulants == interferon alpha == interferon beta == interferon gamma
NDA Applicant: Hoffmann-La Roche Inc.      BLA No.: 103145  Prod. No.: 001 Disc (3MIU/0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 21, 1995Orphan Designation: Treatment of AIDS related Kaposi's sarcoma.

Hoffmann-La Roche Inc.
Zenapax (Injection) (Intravenous) daclizumab
Drug Classes: interleukin-2 receptor blocking antibody
NDA Applicant: Hoffmann-La Roche Inc.      BLA No.: 103749  Prod. No.: 001 Disc (25MG/5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 10, 2004Orphan Designation: Prevention of acute renal allograft rejection.
Approved Labeled Indication: Prophylaxis of acute organ rejection in patients receiving renal transplants, to be used as a part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.

Horizon Therapeutics Ireland DAC
Actimmune (Injection) (Subcutaneous) interferon gamma-1b
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == Immunological Agents:Immunostimulants == interferon alpha == interferon beta == interferon gamma
NDA Applicant: Horizon Therapeutics Ireland DAC      BLA No.: 103836  Prod. No.: 001 Rx (100MCG(2MILLION INTERNATIONAL UNITS)/0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 20, 1997Orphan Designation: Treatment of chronic granulomatous disease.
Exclusivity Type: Orphan Drug ExclusivityFeb 10, 2007Orphan Designation: Delaying time to disease progression in patients with severe, malignant osteopetrosis.
Approved Labeled Indication: Delaying time to disease progression in patients with severe, malignant osteopetrosis.

Horizon Therapeutics Ireland DAC
Krystexxa (Injection) (Intravenous) pegloticase
Drug Classes: Antigout Agents
NDA Applicant: Horizon Therapeutics Ireland DAC      BLA No.: 125293  Prod. No.: 001 Rx (8MG/1ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 14, 2017Orphan Designation: To control the clinical consequences of hyperuricemia in patients with severe gout in whom conventional therapy is contraindicated or has been ineffective
Approved Labeled Indication: Treatment of chronic gout in adult patients refractory to conventional treatment

Horizon Therapeutics Ireland DAC
Tepezza (For Injection) (Intravenous) teprotumumab-trbw
NDA Applicant: Horizon Therapeutics Ireland DAC      BLA No.: 761143  Prod. No.: 001 Rx (500MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 21, 2027Orphan Designation: Treatment of active thyroid eye disease
Approved Labeled Indication: TEPEZZA is indicated for the treatment of Thyroid Eye Disease.
Exclusivity Protected Indication: For the treatment of active Thyroid Eye Disease

Horizon Therapeutics Ireland DAC
Uplizna (Injection) (Intravenous) inebilizumab-cdon
NDA Applicant: Horizon Therapeutics Ireland DAC      BLA No.: 761142  Prod. No.: 001 Rx (100MG/10ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 11, 2027Orphan Designation: Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorders
Approved Labeled Indication: Uplizna is indicated for for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Exclusivity Protected Indication: Indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.



Last edited: 15 November 2022
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