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Generated: December 12, 2017

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Doxorubicin hydrochloride - Generic Drug Details

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What are the generic sources for doxorubicin hydrochloride and what is the scope of doxorubicin hydrochloride freedom to operate?

Doxorubicin hydrochloride
is the generic ingredient in five branded drugs marketed by Janssen Res And Dev, Dr Reddys Labs Ltd, Sun Pharma Global, Pharmacia And Upjohn, Actavis Inc, Alvogen Inc, Amneal Pharms Co, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Labs Ltd, Pharmachemie Bv, Sagent Pharms, Sandoz Inc, Sun Pharm Inds, Teva Pharms Usa, West-ward Pharms Int, and Bristol Myers Squibb, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for doxorubicin hydrochloride. Sixteen suppliers are listed for this compound.

Pharmacology for doxorubicin hydrochloride

Medical Subject Heading (MeSH) Categories for doxorubicin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Sun Pharma GlobalDOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)doxorubicin hydrochlorideINJECTABLE, LIPOSOMAL;INJECTION203263-002Feb 4, 2013ABRXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Pharmachemie BvDOXORUBICIN HYDROCHLORIDEdoxorubicin hydrochlorideINJECTABLE;INJECTION063336-004Feb 28, 1995APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva Pharms UsaDOXORUBICIN HYDROCHLORIDEdoxorubicin hydrochlorideINJECTABLE;INJECTION064140-001Jul 28, 1995APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Janssen Res And DevDOXIL (LIPOSOMAL)doxorubicin hydrochlorideINJECTABLE, LIPOSOMAL;INJECTION050718-002Jun 13, 2000ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Pharmacia And UpjohnDOXORUBICIN HYDROCHLORIDEdoxorubicin hydrochlorideINJECTABLE;INJECTION050467-004Jul 22, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis IncDOXORUBICIN HYDROCHLORIDEdoxorubicin hydrochlorideINJECTABLE;INJECTION203622-001Jun 27, 2014APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Pharmacia And UpjohnDOXORUBICIN HYDROCHLORIDEdoxorubicin hydrochlorideINJECTABLE;INJECTION050467-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdDOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)doxorubicin hydrochlorideINJECTABLE, LIPOSOMAL;INJECTION208657-001May 15, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Pharmacia And UpjohnDOXORUBICIN HYDROCHLORIDEdoxorubicin hydrochlorideINJECTABLE;INJECTION050629-003Mar 28, 2011RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Sandoz IncDOXORUBICIN HYDROCHLORIDEdoxorubicin hydrochlorideINJECTABLE;INJECTION200146-001Jul 18, 2012DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: doxorubicin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Res And DevDOXIL (LIPOSOMAL)doxorubicin hydrochlorideINJECTABLE, LIPOSOMAL;INJECTION050718-001Nov 17, 1995► Subscribe► Subscribe
Janssen Res And DevDOXIL (LIPOSOMAL)doxorubicin hydrochlorideINJECTABLE, LIPOSOMAL;INJECTION050718-002Jun 13, 2000► Subscribe► Subscribe
Janssen Res And DevDOXIL (LIPOSOMAL)doxorubicin hydrochlorideINJECTABLE, LIPOSOMAL;INJECTION050718-002Jun 13, 2000► Subscribe► Subscribe
Janssen Res And DevDOXIL (LIPOSOMAL)doxorubicin hydrochlorideINJECTABLE, LIPOSOMAL;INJECTION050718-001Nov 17, 1995► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
UBS
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Dow
Merck
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Cipla
AstraZeneca
Baxter
McKinsey

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