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Digital content
NEWS #PharmaBuzz
12 Feb 2026
// BUSINESSWIRE
https://www.businesswire.com/news/home/20260211590882/en/Alkermes-plc-Completes-Acquisition-of-Avadel-Pharmaceuticals-plc-Accelerating-Entry-Into-Sleep-Medicine-Market
11 Feb 2026
// BUSINESSWIRE
https://www.businesswire.com/news/home/20260210073328/en/Alkermes-to-Report-Fourth-Quarter-and-Year-End-Financial-Results-on-Feb.-25-2026
10 Feb 2026
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2026/02/10/3235774/0/en/Avadel-Pharmaceuticals-Announces-Outcome-of-the-Court-Sanction-Hearing.html
12 Jan 2026
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2026/01/12/3217352/0/en/Avadel-Pharmaceuticals-Announces-that-Avadel-Shareholders-Approve-the-Proposed-Acquisition-by-Alkermes.html
06 Jan 2026
// BUSINESSWIRE
https://www.businesswire.com/news/home/20260106871102/en/Alixorexton-Granted-Breakthrough-Therapy-Designation-by-U.S.-FDA-for-the-Treatment-of-Narcolepsy-Type-1
30 Dec 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20251229760927/en/Alkermes-to-Present-at-the-44th-Annual-J.P.-Morgan-Healthcare-Conference
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12571
Submission : 1997-07-09
Status : Active
Type : II
Registration Number : 225MF10176
Registrant's Address : Floor 1, The Crescent Building, Northwood Park, Northwood, Dublin 9, Co. Dublin, Ireland, D09 X8W3
Initial Date of Registration : 2013-09-18
Latest Date of Registration :
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2013-03-29
Registration Number : 20130329-190-I-83-01
Manufacturer Name : Lonza AG@Novo Nordisk Production Ireland Limited
Manufacturer Address : Lonzastrasse, CH-3930 Visp, Switzerland@Monksland, Athlone, County Westmeath, Ireland (sirolimus dispersion solution manufacturing plant)
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29273
Submission : 2015-07-15
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22739
Submission : 2009-05-05
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22903
Submission : 2009-06-23
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13957
Submission : 1999-01-22
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18805
Submission : 2005-09-26
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16433
Submission : 2003-02-21
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14028
Submission : 1999-03-18
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20561
Submission : 2007-06-25
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22755
Submission : 2009-05-01
Status : Inactive
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Drugs in Development
Details:
Under the acquisition of Sodium Oxybate, a controlled substance targeting the GABA-B receptor, the deal aims to advance treatment for idiopathic hypersomnia.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Musculoskeletal Brand Name: Lumryz
Study Phase: Approved FDFProduct Type: Controlled Substance
Recipient: Avadel Pharmaceuticals
Deal Size: $2,370.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition November 19, 2025
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Recipient : Avadel Pharmaceuticals
Deal Size : $2,370.0 million
Deal Type : Acquisition
Alkermes plc Raises Offer to Acquire Avadel Pharmaceuticals plc
Details : Under the acquisition of Sodium Oxybate, a controlled substance targeting the GABA-B receptor, the deal aims to advance treatment for idiopathic hypersomnia.
Product Name : Lumryz
Product Type : Controlled Substance
Upfront Cash : Undisclosed
November 19, 2025
Details:
Through the acquisition of Sodium Oxybate, a controlled substance targeting the GABA-B receptor, the deal aims to advance treatment options for narcolepsy.
Lead Product(s): Sodium Oxybate
Therapeutic Area: Sleep Brand Name: Lumryz
Study Phase: Approved FDFProduct Type: Controlled Substance
Recipient: Avadel Pharmaceuticals
Deal Size: $2,100.0 million Upfront Cash: $2,100.0 million
Deal Type: Acquisition October 22, 2025
Lead Product(s) : Sodium Oxybate
Therapeutic Area : Sleep
Highest Development Status : Approved FDF
Recipient : Avadel Pharmaceuticals
Deal Size : $2,100.0 million
Deal Type : Acquisition
Alkermes plc to Acquire Avadel Pharmaceuticals plc
Details : Through the acquisition of Sodium Oxybate, a controlled substance targeting the GABA-B receptor, the deal aims to advance treatment options for narcolepsy.
Product Name : Lumryz
Product Type : Controlled Substance
Upfront Cash : $2,100.0 million
October 22, 2025
Details:
ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for idiopathic hypersomnia.
Lead Product(s): ALKS 2680
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 01, 2025
Lead Product(s) : ALKS 2680
Therapeutic Area : Sleep
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Alkermes Announces Initiation of Phase 2 Evaluating ALKS 2680 for Idiopathic Hypersomnia
Details : ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for idiopathic hypersomnia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 01, 2025
Details:
ALKS 2680 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Idiopathic Hypersomnia.
Lead Product(s): ALKS 2680
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 25, 2025
Details : ALKS 2680 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Idiopathic Hypersomnia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 25, 2025
Details:
ALKS2680 is a drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Narcolepsy.
Lead Product(s): ALKS2680
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase II/ Phase IIIProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 10, 2025
Lead Product(s) : ALKS2680
Therapeutic Area : Sleep
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
Details : ALKS2680 is a drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Narcolepsy.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
January 10, 2025
Details:
ALKS 2680 is an investigational, oral, selective orexin 2 receptor (OX2R) agonist, which is being evaluated for the treatment of patients with narcolepsy type 2.
Lead Product(s): ALKS 2680
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 22, 2024
Alkermes Begins Phase 2 Study of ALKS 2680 for Narcolepsy Type 2
Details : ALKS 2680 is an investigational, oral, selective orexin 2 receptor (OX2R) agonist, which is being evaluated for the treatment of patients with narcolepsy type 2.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 22, 2024
Details:
ALKS 2680 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Narcolepsy.
Lead Product(s): ALKS 2680
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 15, 2024
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2
Details : ALKS 2680 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Narcolepsy.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 15, 2024
Details:
ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor agonist, which is being evaluated in the mid-stage clinical trials for the treatment of narcolepsy type 1.
Lead Product(s): ALKS 2680
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 24, 2024
Alkermes Initiates Vibrance-1 Phase 2 Study of ALKS 2680 for Narcolepsy Type 1 Treatment
Details : ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor agonist, which is being evaluated in the mid-stage clinical trials for the treatment of narcolepsy type 1.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 24, 2024
Details:
ALKS 2680 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Narcolepsy.
Lead Product(s): ALKS 2680
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 11, 2024
Details : ALKS 2680 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Narcolepsy.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 11, 2024
Details:
ALKS 2680 is the company's novel, investigational, oral orexin 2 receptor (OX2R) agonist, which is being evaluated for the treatment of narcolepsy type 2 & idiopathic hypersomnia.
Lead Product(s): ALKS 2680
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 09, 2024
Alkermes Announces Positive Phase 1b Results for ALKS 2680 in Narcolepsy Type 2 Patients
Details : ALKS 2680 is the company's novel, investigational, oral orexin 2 receptor (OX2R) agonist, which is being evaluated for the treatment of narcolepsy type 2 & idiopathic hypersomnia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 09, 2024
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
Excipients
Inspections and registrations
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Alkermes Plc is a supplier offers 12 products (APIs, Excipients or Intermediates).
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