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Last Updated: September 27, 2020

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DACTINOMYCIN Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Dactinomycin

A generic version of DACTINOMYCIN was approved as dactinomycin by MYLAN LABS LTD on November 9th, 2017.

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Drug patent expirations by year for DACTINOMYCIN
Drug Prices for DACTINOMYCIN

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Recent Clinical Trials for DACTINOMYCIN

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SponsorPhase
Shengjing HospitalPhase 4
Washington University School of MedicinePhase 1/Phase 2
St. Jude Children's Research HospitalPhase 2

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Pharmacology for DACTINOMYCIN

US Patents and Regulatory Information for DACTINOMYCIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Regent DACTINOMYCIN dactinomycin INJECTABLE;INJECTION 202562-001 Aug 23, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int DACTINOMYCIN dactinomycin INJECTABLE;INJECTION 090304-001 Mar 16, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Hisun Pharm Hangzhou DACTINOMYCIN dactinomycin INJECTABLE;INJECTION 207232-001 Jul 16, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd DACTINOMYCIN dactinomycin INJECTABLE;INJECTION 203385-001 Nov 9, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Xgen Pharms DACTINOMYCIN dactinomycin INJECTABLE;INJECTION 203999-001 May 20, 2019 AP RX 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
AstraZeneca
Merck
McKinsey
Medtronic
Johnson and Johnson

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