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Last Updated: December 2, 2022

Methylprednisolone sodium succinate - Generic Drug Details


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What are the generic drug sources for methylprednisolone sodium succinate and what is the scope of freedom to operate?

Methylprednisolone sodium succinate is the generic ingredient in four branded drugs marketed by Abbott, Hospira, Hospira Inc, Elkins Sinn, Organon Usa Inc, Abraxis Pharm, Amneal, Bedford Labs, Eugia Pharma, Fresenius Kabi Usa, Hikma, Intl Medication, Sagent Pharms Inc, Teva Parenteral, Tianjin Kingyork, Watson Labs, and Pharmacia And Upjohn, and is included in forty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for methylprednisolone sodium succinate. Fifteen suppliers are listed for this compound.

Summary for methylprednisolone sodium succinate
Recent Clinical Trials for methylprednisolone sodium succinate

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

SponsorPhase
Nihon Pharmaceutical Co., LtdPhase 3
University Children's Hospital BaselPhase 3
University of Roma La SapienzaPhase 3

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Pharmacology for methylprednisolone sodium succinate

US Patents and Regulatory Information for methylprednisolone sodium succinate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Parenteral METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate INJECTABLE;INJECTION 081267-001 Nov 30, 1992 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hospira A-METHAPRED methylprednisolone sodium succinate INJECTABLE;INJECTION 089173-001 Aug 18, 1987 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Elkins Sinn METHYLPREDNISOLONE methylprednisolone sodium succinate INJECTABLE;INJECTION 086906-004 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Parenteral METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate INJECTABLE;INJECTION 081266-001 Nov 30, 1992 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sagent Pharms Inc METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate INJECTABLE;INJECTION 040888-001 Jul 18, 2011 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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