METHYLPREDNISOLONE - Generic Drug Details

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What are the generic drug 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, Chartwell Rx, Duramed Pharms Barr, Endo Operations, Heather, Invatech, Jubilant Cadista, Novast Labs, Par Pharm, Praxgen, Sandoz, Tianjin Tianyao, Watson Labs, Zydus Pharms, Pharmacia And Upjohn, Bel Mar, Epic Pharma Llc, Eugia Pharma, Hong Kong, Sagent Pharms Inc, Teva Pharms Usa, Wilshire Pharms Inc, Abbott, Hospira, Hospira Inc, Elkins Sinn, Organon Usa Inc, Abraxis Pharm, Bedford Labs, Fresenius Kabi Usa, Hikma, Intl Medication, Teva Parenteral, and Tianjin Kingyork, and is included in ninety-two NDAs. Additional information is available in the individual branded drug profile pages.

There are forty drug master file entries for methylprednisolone. Thirty suppliers are listed for this compound.

Summary for METHYLPREDNISOLONE

US Patents:	0
Tradenames:	11
Applicants:	35
NDAs:	92
Drug Master File Entries:	40
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	830
Patent Applications:	7,330
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

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Drug Sales Revenue Trends for METHYLPREDNISOLONE

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Recent Clinical Trials for METHYLPREDNISOLONE

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

Sponsor	Phase
University Hospital, Antwerp	Phase 3
Kasr El Aini Hospital	N/A
Hospital General Universitario de Alicante	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
Hospira	A-METHAPRED	methylprednisolone sodium succinate	INJECTABLE;INJECTION	085853-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	A-METHAPRED	methylprednisolone sodium succinate	INJECTABLE;INJECTION	089173-001	Aug 18, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbott	A-METHAPRED	methylprednisolone sodium succinate	INJECTABLE;INJECTION	089576-001	Feb 22, 1991		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abraxis Pharm	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	089187-001	Mar 28, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	METHYLPREDNISOLONE	methylprednisolone	TABLET;ORAL	209097-001	Feb 22, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	040583-001	Jul 30, 2004	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	METHYLPREDNISOLONE ACETATE	methylprednisolone acetate	INJECTABLE;INJECTION	210043-002	May 20, 2019	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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