PREDNISONE - Generic Drug Details
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What are the generic drug sources for prednisone and what is the scope of freedom to operate?
Prednisone
is the generic ingredient in thirteen branded drugs marketed by Hikma, Xttrium Labs Inc, Muro, Actavis Labs Fl Inc, Horizon, Halsey, Bayer Pharms, Pharmacia And Upjohn, Ferndale Labs, Schering, Solvay, Parke Davis, Schwarz Pharma, Am Therap, Amneal, Amneal Pharms Ny, Aurobindo Pharma Ltd, Bundy, Chartwell Molecular, Chartwell Rx, Contract Pharmacal, Duramed Pharms Barr, Elkins Sinn, Endo Operations, Everylife, Ferrante, Geneyork Pharms, Granulation Tech, Heather, Hikma Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Jubilant Cadista, Kv Pharm, Lederle, Marshall Pharma, Mutual Pharm, Mylan, Novitium Pharma, Nylos, Panray, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Rexall, Rising, Roxane, Sandoz, Scherer Labs, Sperti, Strides Pharma, Sun Pharm Industries, Superpharm, Teva, UDL, Upsher Smith, Valeant Pharm Intl, Vangard, Vitarine, Watson Labs, and Whiteworth Town Plsn, and is included in one hundred and twenty-nine NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Prednisone has fifty-three patent family members in twenty-nine countries.
There are sixteen drug master file entries for prednisone. Forty-nine suppliers are listed for this compound.
Summary for PREDNISONE
International Patents: | 53 |
US Patents: | 6 |
Tradenames: | 13 |
Applicants: | 63 |
NDAs: | 129 |
Drug Master File Entries: | 16 |
Finished Product Suppliers / Packagers: | 49 |
Raw Ingredient (Bulk) Api Vendors: | 90 |
Clinical Trials: | 2,021 |
Patent Applications: | 5,734 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for PREDNISONE |
Drug Sales Revenues: | Drug sales revenues for PREDNISONE |
What excipients (inactive ingredients) are in PREDNISONE? | PREDNISONE excipients list |
DailyMed Link: | PREDNISONE at DailyMed |
Recent Clinical Trials for PREDNISONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Zhejiang University | Phase 3 |
Merck Sharp & Dohme LLC | Phase 3 |
Orion Corporation, Orion Pharma | Phase 3 |
Pharmacology for PREDNISONE
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for PREDNISONE
Anatomical Therapeutic Chemical (ATC) Classes for PREDNISONE
Paragraph IV (Patent) Challenges for PREDNISONE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
RAYOS | Delayed-release Tablets | prednisone | 5 mg | 202020 | 1 | 2012-11-26 |
US Patents and Regulatory Information for PREDNISONE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Kv Pharm | PREDNISONE | prednisone | TABLET;ORAL | 084236-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Aurobindo Pharma Ltd | PREDNISONE | prednisone | TABLET;ORAL | 215672-005 | Mar 28, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Panray | PREDNISONE | prednisone | TABLET;ORAL | 080350-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Whiteworth Town Plsn | PREDNISONE | prednisone | TABLET;ORAL | 089028-001 | Jul 24, 1986 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Rising | PREDNISONE | prednisone | TABLET;ORAL | 089983-001 | Jan 12, 1989 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Jubilant Cadista | PREDNISONE | prednisone | TABLET;ORAL | 040362-003 | Jun 29, 2005 | AB | RX | No | No | ⤷ 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 |
Expired US Patents for PREDNISONE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Horizon | RAYOS | prednisone | TABLET, DELAYED RELEASE;ORAL | 202020-001 | Jul 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Horizon | RAYOS | prednisone | TABLET, DELAYED RELEASE;ORAL | 202020-002 | Jul 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Horizon | RAYOS | prednisone | TABLET, DELAYED RELEASE;ORAL | 202020-002 | Jul 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Horizon | RAYOS | prednisone | TABLET, DELAYED RELEASE;ORAL | 202020-001 | Jul 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Horizon | RAYOS | prednisone | TABLET, DELAYED RELEASE;ORAL | 202020-001 | Jul 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Horizon | RAYOS | prednisone | TABLET, DELAYED RELEASE;ORAL | 202020-002 | Jul 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PREDNISONE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1113915 | ⤷ Sign Up | |
Portugal | 1631251 | ⤷ Sign Up | |
South Africa | 200509477 | Delayed release tablet with defined core geometry | ⤷ Sign Up |
European Patent Office | 2049123 | TRAITEMENT GLUCOCORTICOÏDIQUE À LIBÉRATION RETARDÉE DE MALADIE RHUMATOÏDE (DELAYED-RELEASE GLUCOCORTICOID TREATMENT OF RHEUMATOID DISEASE) | ⤷ Sign Up |
Singapore | 174026 | DELAYED-RELEASE GLUCOCORTICOID TREATMENT OF RHEUMATOID DISEASE | ⤷ Sign Up |
Norway | 20090958 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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