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Last Updated: August 10, 2020

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ETOPOSIDE PHOSPHATE - Generic Drug Details

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What are the generic sources for etoposide phosphate and what is the scope of freedom to operate?

Etoposide phosphate is the generic ingredient in one branded drug marketed by Bristol Myers Squibb and Cheplapharm, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for etoposide phosphate. Two suppliers are listed for this compound.

Recent Clinical Trials for ETOPOSIDE PHOSPHATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Merck Sharp & Dohme Corp.Phase 2
Incyte CorporationPhase 2/Phase 3
Baxalta US Inc.Phase 2/Phase 3

See all ETOPOSIDE PHOSPHATE clinical trials

Pharmacology for ETOPOSIDE PHOSPHATE

US Patents and Regulatory Information for ETOPOSIDE PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb ETOPOPHOS PRESERVATIVE FREE etoposide phosphate INJECTABLE;INJECTION 020906-001 Feb 27, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Cheplapharm ETOPOPHOS PRESERVATIVE FREE etoposide phosphate INJECTABLE;INJECTION 020457-001 May 17, 1996 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb ETOPOPHOS PRESERVATIVE FREE etoposide phosphate INJECTABLE;INJECTION 020906-002 Feb 27, 1998 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

Expired US Patents for ETOPOSIDE PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cheplapharm ETOPOPHOS PRESERVATIVE FREE etoposide phosphate INJECTABLE;INJECTION 020457-001 May 17, 1996   Start Trial   Start Trial
Bristol Myers Squibb ETOPOPHOS PRESERVATIVE FREE etoposide phosphate INJECTABLE;INJECTION 020906-002 Feb 27, 1998   Start Trial   Start Trial
Bristol Myers Squibb ETOPOPHOS PRESERVATIVE FREE etoposide phosphate INJECTABLE;INJECTION 020906-001 Feb 27, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Johnson and Johnson
McKesson
Express Scripts
Baxter

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