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Last Updated: October 30, 2020

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ACYCLOVIR SODIUM Drug Profile

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When do Acyclovir Sodium patents expire, and when can generic versions of Acyclovir Sodium launch?

Acyclovir Sodium is a drug marketed by Apothecon, Athenex Inc, Aurobindo Pharma Ltd, Eurohlth Intl Sarl, Exela Pharma, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Teva Parenteral, and Zydus Pharms. and is included in seventeen NDAs.

The generic ingredient in ACYCLOVIR SODIUM is acyclovir sodium. There are fifty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Acyclovir Sodium

A generic version of ACYCLOVIR SODIUM was approved as acyclovir sodium by FRESENIUS KABI USA on May 13th, 1998.

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Drug patent expirations by year for ACYCLOVIR SODIUM
Drug Prices for ACYCLOVIR SODIUM

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Recent Clinical Trials for ACYCLOVIR SODIUM

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

See all ACYCLOVIR SODIUM clinical trials

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
Apothecon ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 074897-002 Feb 27, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 074758-001 Apr 22, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Zydus Pharms ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 206535-002 Aug 31, 2018 RX No Yes   Start Trial   Start Trial   Start Trial
Eurohlth Intl Sarl ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 074913-001 Oct 15, 1997 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:

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Boehringer Ingelheim
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Harvard Business School
Merck

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