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Last Updated: August 4, 2020

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Raloxifene hydrochloride - Generic Drug Details

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

Raloxifene hydrochloride is the generic ingredient in two branded drugs marketed by Lilly, Amneal Pharms, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Invagen Pharms, Sciegen Pharms Inc, Teva Pharms Usa, and Watson Labs Inc, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for raloxifene hydrochloride. Fifteen suppliers are listed for this compound.

Recent Clinical Trials for raloxifene hydrochloride

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

SponsorPhase
Monash HealthPhase 4
Massachusetts General HospitalPhase 4
Laboratorios Grossman, S.A.Phase 3

See all raloxifene hydrochloride clinical trials

Pharmacology for raloxifene hydrochloride
Medical Subject Heading (MeSH) Categories for raloxifene hydrochloride
Paragraph IV (Patent) Challenges for RALOXIFENE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
EVISTA TABLET;ORAL raloxifene hydrochloride 020815

US Patents and Regulatory Information for raloxifene hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sciegen Pharms Inc RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride TABLET;ORAL 206384-001 Oct 12, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Invagen Pharms RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride TABLET;ORAL 090842-001 Sep 24, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Lilly EVISTA raloxifene hydrochloride TABLET;ORAL 020815-001 Dec 9, 1997 AB RX Yes Yes   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 raloxifene hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly EVISTA raloxifene hydrochloride TABLET;ORAL 020815-001 Dec 9, 1997   Start Trial   Start Trial
Lilly EVISTA raloxifene hydrochloride TABLET;ORAL 020815-001 Dec 9, 1997   Start Trial   Start Trial
Lilly EVISTA raloxifene hydrochloride TABLET;ORAL 020815-001 Dec 9, 1997   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:

AstraZeneca
Boehringer Ingelheim
Merck
McKinsey
Colorcon
Mallinckrodt

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