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Last Updated: May 10, 2021

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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, Cadila Pharms Ltd, Glenmark Pharms Ltd, Invagen Pharms, Sciegen Pharms Inc, Teva Pharms Usa, and Watson Labs Inc, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for raloxifene hydrochloride
Recent Clinical Trials for raloxifene hydrochloride

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

SponsorPhase
Monash HealthPhase 4
Massachusetts General HospitalPhase 4
Instituto Nacional de Salud Publica, MexicoPhase 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
Glenmark Pharms Ltd RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride TABLET;ORAL 204491-001 Mar 22, 2016 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Lilly EVISTA raloxifene hydrochloride TABLET;ORAL 020815-001 Dec 9, 1997 AB RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Teva Pharms Usa RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride TABLET;ORAL 078193-001 Mar 4, 2014 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Aurobindo Pharma Ltd RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride TABLET;ORAL 204310-001 Aug 28, 2015 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Watson Labs Inc RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride TABLET;ORAL 200825-001 Jan 21, 2015 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Invagen Pharms RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride TABLET;ORAL 090842-001 Sep 24, 2014 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Cadila Pharms Ltd RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride TABLET;ORAL 211324-001 Aug 18, 2020 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
>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

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
Merck
McKinsey
Colorcon
Mallinckrodt

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