Methylprednisolone - Generic Drug Details

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

Methylprednisolone is the generic ingredient in eleven branded drugs marketed by Pfizer, Amneal, Duramed Pharms Barr, Heather, Invatech, Jubilant Cadista, Lupin Ltd, Novast Labs, Par Pharm, Praxgen, Sandoz, Tianjin Tianyao, Vintage Pharms, Watson Labs, Zydus Pharms, Pharmacia And Upjohn, Bel Mar, Akorn, Par Sterile Products, Sagent Pharms Inc, Sandoz Inc, Teva Pharms Usa, Abbott, Hospira, Hospira Inc, Elkins Sinn, Organon Usa Inc, Abraxis Pharm, Bedford Labs, Eugia Pharma, Fresenius Kabi Usa, Hikma, Intl Medication, Teva Parenteral, and Tianjin Kingyork, and is included in eighty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are forty drug master file entries for methylprednisolone. Twenty-nine suppliers are listed for this compound.

Summary for methylprednisolone

US Patents:	0
Tradenames:	11
Applicants:	35
NDAs:	89
Drug Master File Entries:	40
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	800
Patent Applications:	7,129
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for methylprednisolone
Drug Sales Revenues:	Drug sales revenues for methylprednisolone
What excipients (inactive ingredients) are in methylprednisolone?	methylprednisolone excipients list
DailyMed Link:	methylprednisolone at DailyMed

See drug prices for methylprednisolone

Drug Sales Revenue Trends for methylprednisolone

See drug sales revenues for methylprednisolone

Recent Clinical Trials for methylprednisolone

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

Sponsor	Phase
Fen Li	Phase 4
Rigshospitalet, Denmark	N/A
Beijing Tongren Hospital	Phase 4

See all methylprednisolone clinical trials

Pharmacology for methylprednisolone

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for methylprednisolone

Anti-Inflammatory Agents
Antiemetics
Glucocorticoids
Neuroprotective Agents

US Patents and Regulatory Information for methylprednisolone

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	040612-001	Aug 12, 2004	AP	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Lupin Ltd	METHYLPREDNISOLONE	methylprednisolone	TABLET;ORAL	209097-001	Feb 22, 2019		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Hospira	A-METHAPRED	methylprednisolone sodium succinate	INJECTABLE;INJECTION	040665-001	Dec 20, 2005		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Hospira Inc	A-METHAPRED	methylprednisolone sodium succinate	INJECTABLE;INJECTION	040793-001	Nov 25, 2008		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Abraxis Pharm	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	089143-001	Mar 28, 1986		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	040888-005	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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