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Last Updated: August 13, 2020

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ACYCLOVIR SODIUM - Generic Drug Details

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What are the generic drug sources for acyclovir sodium and what is the scope of patent protection?

Acyclovir sodium is the generic ingredient in four branded drugs marketed by Abbvie, Eurohlth Intl Sarl, Apothecon, Athenex Inc, Aurobindo Pharma Ltd, Exela Pharma Scs Llc, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Teva Parenteral, Zydus Pharms, and Glaxosmithkline, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

There are fifty-six drug master file entries for acyclovir sodium. Five suppliers are listed for this compound.


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Recent Clinical Trials for ACYCLOVIR SODIUM

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Haining Health-Coming Biotech Co., Ltd.Phase 2
Peking University People's HospitalPhase 4
CttqPhase 4

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Paragraph IV (Patent) Challenges for ACYCLOVIR SODIUM
Tradename Dosage Ingredient NDA Submissiondate
ZOVIRAX INJECTABLE;INJECTION acyclovir sodium 018603

US Patents and Regulatory Information for ACYCLOVIR SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 074663-001 Apr 22, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Eurohlth Intl Sarl ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE acyclovir sodium INJECTABLE;INJECTION 074885-002 Dec 19, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Athenex Inc ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 074596-002 Apr 22, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Zydus Pharms ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 206606-001 Jun 13, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

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