Acyclovir Patent Expiration

Acyclovir is Used for treating cold sores caused by the herpes simplex virus. It was first introduced by Bausch Health Us Llc in its drug Zovirax on Mar 29, 1982. Other drugs containing Acyclovir are Sitavig, Avaclyr. 51 different companies have introduced drugs containing Acyclovir.


Acyclovir Patents

Given below is the list of patents protecting Acyclovir, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Sitavig US8592434 Mucoadhesive buccal tablets for the treatment of orofacial herpes Jun 16, 2030 Ligand Pharms
Sitavig US8747896 Mucosal bioadhesive slow release carrier for delivering active principles Jun 03, 2027 Ligand Pharms
Sitavig US8791127 Mucosal bioadhesive slow release carrier for delivering active principles Mar 23, 2027 Ligand Pharms



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Acyclovir's patents.

Given below is the list recent legal activities going on the following patents of Acyclovir.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 18 Dec, 2025 US8791127
Payment of Maintenance Fee, 12th Year, Large Entity 19 Nov, 2025 US8747896
Payment of Maintenance Fee, 12th Year, Large Entity 24 Apr, 2025 US8592434
Payment of Maintenance Fee, 8th Year, Large Entity 16 Dec, 2021 US8791127
Payment of Maintenance Fee, 8th Year, Large Entity 17 Nov, 2021 US8747896
Payment of Maintenance Fee, 8th Year, Large Entity 22 Apr, 2021 US8592434
Email Notification 22 Sep, 2020 US8747896
Mail O.P. Petition Decision 22 Sep, 2020 US8747896
Email Notification 22 Sep, 2020 US8791127
Mail O.P. Petition Decision 22 Sep, 2020 US8791127


Acyclovir's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Acyclovir:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients Virginia Commonwealth University NA COMPLETED
(Sep 1, 2026)
PHASE3
A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec Candel Therapeutics, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE2
Trial of C134 in Patients With Recurrent GBM University of Alabama at Birmingham NA COMPLETED
(Aug 1, 2026)
PHASE1
A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT Genzyme, a Sanofi Company NA TERMINATED
(Jul 1, 2026)
PHASE3
Effects of Antiviral Therapies on Epstein-Barr Virus Replication Massachusetts General Hospital NA ENROLLING BY INVITATION
(Jul 1, 2026)
PHASE2
R-MVST Cells for Treatment of Viral Infections in Children and Young Adults Monica Bhatia NA RECRUITING
(Jul 1, 2026)
PHASE1
Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects AiCuris Anti-infective Cures AG NA COMPLETED
(Jun 1, 2026)
PHASE3
R-MVST Cells for Treatment of Viral Infections Columbia University NA RECRUITING
(Jun 1, 2026)
PHASE1
Virus-Based Gene Therapy (AdV-HSV1-TK and AdV-Flt3L) in Combination With Valacyclovir for the Treatment of Pediatric and Young Adult Patients With Resectable, Recurrent Primary Malignant Brain Tumors University of Michigan Rogel Cancer Center NA RECRUITING
(Jun 1, 2026)
PHASE1
Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma Trogenix ltd NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Aglatimagene Besadenovec + Prodrug and Pembrolizumab vs Docetaxel for Stage IV Non-Squamous NSCLC Progressing on Pembrolizumab (AURORA) Candel Therapeutics, Inc. NA RECRUITING
(Jun 1, 2026)
PHASE3
Letermovir for CMV Prevention After Lung Transplantation Fernanda P Silveira, MD, MS NA COMPLETED
(Mar 1, 2026)
PHASE2
Intralesional Therapies For Cutaneous Viral Warts: A Comparative Analysis Of Vitamin D3 And Acyclovir Riphah International University NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE4


Acyclovir Generic API Manufacturers

Several generic applications have been filed for Acyclovir. The first generic version for Acyclovir was by Roxane Laboratories Inc and was approved on Apr 22, 1997. And the latest generic version is by Cipla Ltd and was approved on May 2, 2025.

Given below is the list of companies who have filed for Acyclovir generic, along with the locations of their manufacturing plants worldwide.