PREDNISONE Drug Patent Profile
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When do Prednisone patents expire, and what generic alternatives are available?
Prednisone is a drug marketed by Hikma, Xttrium Labs Inc, Actavis Labs Fl Inc, Am Therap, Amneal, Amneal Pharms Ny, Aurobindo Pharma Ltd, Bundy, Chartwell Molecular, Chartwell Rx, Contract Pharmacal, Duramed Pharms Barr, Elkins Sinn, Everylife, Ferrante, Geneyork Pharms, Granulation Tech, Halsey, 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, Vintage Pharms, Vitarine, Watson Labs, and Whiteworth Town Plsn. and is included in one hundred and seventeen NDAs.
The generic ingredient in PREDNISONE is prednisone. There are sixteen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the prednisone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Prednisone
A generic version of PREDNISONE was approved as prednisone by WATSON LABS on December 31st, 1969.
Summary for PREDNISONE
Recent Clinical Trials for PREDNISONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
MacroGenics | Phase 2 |
Philippe Armand, MD, PhD | Phase 2 |
Liaoning Tumor Hospital & Institute | Phase 2 |
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 | 1 mg, 2 mg, and 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jubilant Cadista | PREDNISONE | prednisone | TABLET;ORAL | 040362-003 | Jun 29, 2005 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Rising | PREDNISONE | prednisone | TABLET;ORAL | 084774-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Geneyork Pharms | PREDNISONE | prednisone | TABLET;ORAL | 210525-002 | Dec 4, 2018 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Everylife | PREDNISONE | prednisone | TABLET;ORAL | 084440-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novitium Pharma | PREDNISONE | prednisone | TABLET;ORAL | 211575-003 | Nov 15, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Strides Pharma | PREDNISONE | prednisone | TABLET;ORAL | 209727-002 | Nov 20, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Watson Labs | PREDNISONE | prednisone | TABLET;ORAL | 080356-001 | Approved Prior to Jan 1, 1982 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |