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METHYLPREDNISOLONE ACETATE - Generic Drug Details
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What are the generic drug sources for methylprednisolone acetate and what is the scope of patent protection?
Methylprednisolone acetate
is the generic ingredient in six branded drugs marketed by Pharmacia And Upjohn, Bel Mar, Akorn, Amneal, Sagent Pharms Inc, Sandoz Inc, Teva Pharms Usa, and Watson Labs, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.There are forty drug master file entries for methylprednisolone acetate. Nine suppliers are listed for this compound.
Summary for METHYLPREDNISOLONE ACETATE
| US Patents: | 0 |
| Tradenames: | 6 |
| Applicants: | 8 |
| NDAs: | 19 |
| Drug Master File Entries: | 40 |
| Suppliers / Packagers: | 9 |
| Bulk Api Vendors: | 50 |
| Clinical Trials: | 24 |
| Patent Applications: | 4,241 |
| Formulation / Manufacturing: | see details |
| Drug Sales Revenues: | Drug sales revenues for METHYLPREDNISOLONE ACETATE |
| DailyMed Link: | METHYLPREDNISOLONE ACETATE at DailyMed |
Recent Clinical Trials for METHYLPREDNISOLONE ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hadassah Medical Organization | Phase 2 |
| Northwestern University | Phase 4 |
| The University of Texas Medical Branch, Galveston | Phase 2 |
Pharmacology for METHYLPREDNISOLONE ACETATE
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for METHYLPREDNISOLONE ACETATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sagent Pharms Inc | METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 201835-002 | Jun 27, 2018 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sandoz Inc | METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 040794-001 | Mar 5, 2009 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Amneal | METHYLPREDNISOLONE ACETATE | methylprednisolone acetate | INJECTABLE;INJECTION | 210043-002 | May 20, 2019 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Bel Mar | M-PREDROL | methylprednisolone acetate | INJECTABLE;INJECTION | 087135-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Pharmacia And Upjohn | MEDROL | methylprednisolone acetate | ENEMA;RECTAL | 018102-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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