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01 Jul 2025
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https://www.fiercepharma.com/manufacturing/hikma-splash-out-1b-us-production-rd-joining-branded-drugmakers-tariff-spurred
27 May 2025
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27 May 2025
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08 May 2025
// REUTERS
https://www.reuters.com/legal/government/hikma-pharma-pay-50-million-settle-narcolepsy-drug-antitrust-case-2025-05-08/
17 Apr 2025
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09 Apr 2025
// REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/jazz-pharma-pay-145-million-settle-narcolepsy-drug-antitrust-case-2025-04-08/
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18126
Submission : 2005-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13220
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16659
Submission : 2003-06-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5541
Submission : 1984-09-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30165
Submission : 2015-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19809
Submission : 2006-09-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29437
Submission : 2015-05-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18727
Submission : 2005-08-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25298
Submission : 2011-09-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16089
Submission : 2002-08-06
Status : Active
Type : II
Details:
Starjemza (ustekinumab) is a human interleukin-12 and -23 antagonist indicated for the treatment of adult patients with moderate to severe plaque psoriasis.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Brand Name: Starjemza
Study Phase: Approved FDFProduct Type: Antibody
Recipient: Bio-Thera Solutions
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 27, 2025
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Recipient : Bio-Thera Solutions
Deal Size : Inapplicable
Deal Type : Inapplicable
Bio-Thera and Hikma Receive FDA Nod for STARJEMZA Injection Referencing STELARA
Details : Starjemza (ustekinumab) is a human interleukin-12 and -23 antagonist indicated for the treatment of adult patients with moderate to severe plaque psoriasis.
Product Name : Starjemza
Product Type : Antibody
Upfront Cash : Inapplicable
May 27, 2025
Details:
Through the acquisition, Hikma holds the rights of Mekinist-Generic (trametinib dimethyl sulfoxide) tablets from Novugen. It is being indicated for the treatment of BRAF-mutated melanoma.
Lead Product(s): Trametinib
Therapeutic Area: Oncology Brand Name: Mekinist-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Recipient: Novugen
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition April 17, 2025
Lead Product(s) : Trametinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Recipient : Novugen
Deal Size : Undisclosed
Deal Type : Acquisition
Hikma acquires Novugen's FDA-approved ANDA for trametinib
Details : Through the acquisition, Hikma holds the rights of Mekinist-Generic (trametinib dimethyl sulfoxide) tablets from Novugen. It is being indicated for the treatment of BRAF-mutated melanoma.
Product Name : Mekinist-Generic
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
April 17, 2025
Details:
Kloxxado delivers 8 mg of naloxone hydrochloride, an opioid antagonist, approved as a ready to use nasal spray to reverse the effects of opioid overdose.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Kloxxado
Study Phase: Approved FDFProduct Type: Controlled Substance
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 20, 2025
Lead Product(s) : Naloxone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Hikma announces Health Canada approval of KLOXXADO® (naloxone HCl) Nasal Spray 8 mg
Details : Kloxxado delivers 8 mg of naloxone hydrochloride, an opioid antagonist, approved as a ready to use nasal spray to reverse the effects of opioid overdose.
Product Name : Kloxxado
Product Type : Controlled Substance
Upfront Cash : Inapplicable
March 20, 2025
Details:
Under the terms of the agreement, Emergent will be responsible for the distribution of Kloxxado (Naloxone HCl). It is being indicated for the treatment of known or suspected opioid overdose.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Kloxxado
Study Phase: Approved FDFProduct Type: Controlled Substance
Sponsor: Emergent BioSolutions
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 14, 2025
Lead Product(s) : Naloxone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Emergent BioSolutions
Deal Size : Undisclosed
Deal Type : Agreement
Emergent BioSolutions Gains Exclusive Rights to KLOXXADO® Nasal Spray
Details : Under the terms of the agreement, Emergent will be responsible for the distribution of Kloxxado (Naloxone HCl). It is being indicated for the treatment of known or suspected opioid overdose.
Product Name : Kloxxado
Product Type : Controlled Substance
Upfront Cash : Undisclosed
January 14, 2025
Details:
Victoza-Generic (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is indicated for the treatment of patients with type 2 diabetes mellitus.
Lead Product(s): Liraglutide
Therapeutic Area: Endocrinology Brand Name: Victoza-Generic
Study Phase: Approved FDFProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 26, 2024
Lead Product(s) : Liraglutide
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
US FDA Approves Hikma's Generic Version of Novo's Diabetes Drug Victoza
Details : Victoza-Generic (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is indicated for the treatment of patients with type 2 diabetes mellitus.
Product Name : Victoza-Generic
Product Type : Peptide
Upfront Cash : Inapplicable
December 26, 2024
Details:
Furosemide injection is indicated in adults & pediatric patients for the treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome.
Lead Product(s): Furosemide
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Furosemide Injection-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 09, 2024
Lead Product(s) : Furosemide
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Hikma launches Furosemide Injection, USP, in the US
Details : Furosemide injection is indicated in adults & pediatric patients for the treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome.
Product Name : Furosemide Injection-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 09, 2024
Details:
Combogesic IV (acetaminophen & ibuprofen) is an opioid-free pain relief medicine approved for adults to relieve mild to moderate pain and manage moderate to severe pain as an adjunct to opioids.
Lead Product(s): Paracetamol,Ibuprofen
Therapeutic Area: Neurology Brand Name: Combogesic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 02, 2024
Lead Product(s) : Paracetamol,Ibuprofen
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Hikma Announces US Launch of COMBOGESIC® IV
Details : Combogesic IV (acetaminophen & ibuprofen) is an opioid-free pain relief medicine approved for adults to relieve mild to moderate pain and manage moderate to severe pain as an adjunct to opioids.
Product Name : Combogesic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 02, 2024
Details:
Under the agreement, Hikma gains right for MAb-B43.13 (oregovomab), a murine monoclonal antibody, being tested in combination with carboplatin and paclitaxel for patients with advanced ovarian cancer, in the Middle East and North Africa (MENA) region.
Lead Product(s): Oregovomab,Carboplatin,Paclitaxel
Therapeutic Area: Oncology Brand Name: MAb-B43.13
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: CanariaBio
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 10, 2023
Lead Product(s) : Oregovomab,Carboplatin,Paclitaxel
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : CanariaBio
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Under the agreement, Hikma gains right for MAb-B43.13 (oregovomab), a murine monoclonal antibody, being tested in combination with carboplatin and paclitaxel for patients with advanced ovarian cancer, in the Middle East and North Africa (MENA) region.
Product Name : MAb-B43.13
Product Type : Antibody
Upfront Cash : Undisclosed
October 10, 2023
Details:
Dobutamine injection stimulates heart muscle and improves blood flow by helping the heart pump better, which is used short-term to treat cardiac decompensation due to weakened heart muscle.
Lead Product(s): Dobutamine Hydrochloride
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Dobutamine-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 14, 2023
Lead Product(s) : Dobutamine Hydrochloride
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Hikma Exceeds 150 Injectable Medicines in The US with Launch of Dobutamine Injection, USP
Details : Dobutamine injection stimulates heart muscle and improves blood flow by helping the heart pump better, which is used short-term to treat cardiac decompensation due to weakened heart muscle.
Product Name : Dobutamine-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 14, 2023
Details:
The efficacy and safety of RYALTRIS (olopatadine hydrochloride) was established in a robust clinical studies program in over 4,000 patients with SAR. Twice-daily RYALTRIS™ provided statistically significant improvement in both nasal and ocular symptoms vs placebo.
Lead Product(s): Olopatadine Hydrochloride,Mometasone Furoate
Therapeutic Area: Immunology Brand Name: Ryaltris
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 30, 2022
Lead Product(s) : Olopatadine Hydrochloride,Mometasone Furoate
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Hikma Launches Ryaltris™ Seasonal Allergic Rhinitis Nasal Spray in The US
Details : The efficacy and safety of RYALTRIS (olopatadine hydrochloride) was established in a robust clinical studies program in over 4,000 patients with SAR. Twice-daily RYALTRIS™ provided statistically significant improvement in both nasal and ocular symptoms...
Product Name : Ryaltris
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 30, 2022
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ABIRATERONE ACETATE
Dosage Strength : 250MG
Packaging :
Approval Date : 2018-10-31
Application Number : 208339
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ACARBOSE
Dosage Strength : 25MG
Packaging :
Approval Date : 2008-05-07
Application Number : 78470
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ACARBOSE
Dosage Strength : 100MG
Packaging :
Approval Date : 2008-05-07
Application Number : 78470
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ACARBOSE
Dosage Strength : 50MG
Packaging :
Approval Date : 2008-05-07
Application Number : 78470
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;INTRAVENOUS
Brand Name : ACETAMINOPHEN
Dosage Strength : 1GM/100ML (10MG/ML)
Packaging :
Approval Date : 2016-06-13
Application Number : 202605
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;INTRAVENOUS
Brand Name : ACETAMINOPHEN
Dosage Strength : 1GM/100ML (10MG/ML)
Packaging :
Approval Date : 2022-06-03
Application Number : 206968
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : CAPSULE;ORAL
Brand Name : BUTALBITAL, ACETAMINOPHEN...
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 2022-03-25
Application Number : 215135
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : CAPSULE;ORAL
Brand Name : BUTALBITAL, ACETAMINOPHEN...
Dosage Strength : 500MG;50MG;40MG
Packaging :
Approval Date : 1998-10-28
Application Number : 40261
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : TABLET;ORAL
Brand Name : BUTALBITAL, ACETAMINOPHEN...
Dosage Strength : 325MG;50MG;40MG
Packaging :
Approval Date : 1995-06-12
Application Number : 89718
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : TABLET;ORAL
Brand Name : BUTALBITAL, ACETAMINOPHEN...
Dosage Strength : 500MG;50MG;40MG
Packaging :
Approval Date : 1999-08-18
Application Number : 40336
Regulatory Info : DISCN
Registration Country : USA
Inspections and registrations
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Hikma Pharmaceuticals is a supplier offers 31 products (APIs, Excipients or Intermediates).
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