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

See drug prices for METHYLPREDNISOLONE

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
Bedford Labs	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	040641-002	Feb 21, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharmacia And Upjohn	SOLU-MEDROL	methylprednisolone sodium succinate	INJECTABLE;INJECTION	011856-006	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	METHYLPREDNISOLONE	methylprednisolone	TABLET;ORAL	206751-004	Apr 23, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	METHYLPREDNISOLONE ACETATE	methylprednisolone acetate	INJECTABLE;INJECTION	086507-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sagent Pharms Inc	METHYLPREDNISOLONE ACETATE	methylprednisolone acetate	INJECTABLE;INJECTION	201835-003	Jun 27, 2018	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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