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  • CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SUSPENSION;ORAL - 200MG/5ML
  • TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Details:

Acyclovir is a synthetic purine nucleoside analogue having high affinity for the enzyme thymidine kinase encoded by HSV and VZV. It has shown in vitro and in vivo inhibitory activity against herpes simplex virus types 1, 2 and varicella-zoster virus (VZV).


Lead Product(s): Aciclovir

Therapeutic Area: Infections and Infectious Diseases Product Name: Zovirax-Generic

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 02, 2023

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Details:

Prevymis (letermovir) is a first-in-class non-nucleoside CMV inhibitor (3,4 dihydro-quinazolines) and inhibits viral replication by specifically targeting the viral terminase complex.


Lead Product(s): Letermovir,Aciclovir

Therapeutic Area: Infections and Infectious Diseases Product Name: Prevymis

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 17, 2023

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Apotex Inc. is recalling certain lots of Apo-Acyclovir (acyclovir) tablets, in 200 mg and 800 mg strengths, due to the presence of a nitrosamine impurity (N-nitrosodimethylamine [NDMA]) above the acceptable level.


Lead Product(s): Aciclovir

Therapeutic Area: Infections and Infectious Diseases Product Name: Apo-Acyclovir

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 28, 2022

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Details:

Under the new Agreement, Sol-Gel has retained collaboration rights to two generic programs acyclovir cream and ivermectin cream related to four generic drug candidates that it believes to have the most value-generating potential.


Lead Product(s): Aciclovir

Therapeutic Area: Infections and Infectious Diseases Product Name: Acyclovir-Generic

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Padagis

Deal Size: $21.0 million Upfront Cash: Undisclosed

Deal Type: Partnership November 04, 2021

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Details:

Novitium Pharma's lead drug, Acyclovir oral suspension, is a synthetic nucleoside analogue active against herpesviruses. The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV.


Lead Product(s): Aciclovir

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: ANI Pharmaceuticals Inc

Deal Size: $372.5 million Upfront Cash: $89.5 million

Deal Type: Acquisition March 09, 2021

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Details:

The agreement gives SYB the right to register, manufacture and market the product in China.


Lead Product(s): Aciclovir,Hydrocortisone

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Shijiazhuang Yuanmai Biotechnology

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement February 24, 2020

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