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Serving leading biopharmaceutical companies globally:

Citi
Harvard Business School
Medtronic
Novartis
Dow
Chubb
Covington
Express Scripts
Fish and Richardson
Farmers Insurance

Generated: November 22, 2017

DrugPatentWatch Database Preview

Prednisone - Generic Drug Details

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What are the generic sources for prednisone and what is the scope of prednisone freedom to operate?

Prednisone
is the generic ingredient in thirteen branded drugs marketed by Halsey, West-ward Pharms Int, Marshall Pharma, Mutual Pharm, Vangard, Inwood Labs, Vitarine, Phoenix Labs Ny, Solvay, Contract Pharmacal, Roxane, Muro, Elkins Sinn, Jubilant Cadista, Aurolife Pharma Llc, Watson Labs, Whiteworth Town Plsn, Lannett, Nylos, Heather, Horizon Pharma, Lederle, Wockhardt, Mylan Pharms Inc, Rexall, Ivax Sub Teva Pharms, Kv Pharm, Sandoz, Valeant Pharm Intl, Hikma Pharms, Everylife, Sun Pharm Inds, Panray, Pvt Form, Purepac Pharm, Schwarz Pharma, Vintage Pharms, Chartwell Rx, Sperti, Parke Davis, Pharmavite, Ferrante, Ferndale Labs, Superpharm, Schering, Actavis Labs Fl Inc, Upsher Smith, Scherer Labs, Bundy, Impax Labs, UDL, Pharmacia And Upjohn, Am Therap, Bayer Pharms, Duramed Pharms Barr, Amneal Pharms Ny, and Teva, and is included in one hundred and nineteen NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Prednisone has sixty-eight patent family members in thirty countries.

There are sixteen drug master file entries for prednisone. Fifty-six suppliers are listed for this compound.

Medical Subject Heading (MeSH) Categories for prednisone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurolife Pharma Llc
PREDNISONE
prednisone
TABLET;ORAL089983-001Jan 12, 1989DISCNNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds
PREDNISONE
prednisone
TABLET;ORAL086596-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Phoenix Labs Ny
PREDNISONE
prednisone
TABLET;ORAL083807-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds
PREDNISONE
prednisone
TABLET;ORAL089247-001Dec 4, 1985ABRXNoNo► Subscribe► Subscribe► Subscribe
Mutual Pharm
PREDNISONE
prednisone
TABLET;ORAL086595-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Udl
PREDNISONE
prednisone
TABLET;ORAL087984-001Jan 18, 1983DISCNNoNo► Subscribe► Subscribe► Subscribe
Horizon Pharma
RAYOS
prednisone
TABLET, DELAYED RELEASE;ORAL202020-003Jul 26, 2012ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Vangard
PREDNISONE
prednisone
TABLET;ORAL087682-001Jan 15, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Sperti
PREDNISONE
prednisone
TABLET;ORAL080359-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Horizon Pharma
RAYOS
prednisone
TABLET, DELAYED RELEASE;ORAL202020-003Jul 26, 2012ABRXYesYes► Subscribe► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: prednisone

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,920,838Delayed-release glucocorticoid treatment of rheumatoid disease► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: prednisone

Country Document Number Estimated Expiration
CroatiaP20130148► Subscribe
Norway20090958► Subscribe
South Africa200809858► Subscribe
Japan2002539167► Subscribe
Spain2400446► Subscribe
Denmark1631251► Subscribe
Cyprus1111835► Subscribe
European Patent Office2049123► Subscribe
Russian Federation2005132451► Subscribe
United Kingdom9905898► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Fuji
Mallinckrodt
Dow
Merck
Covington
Cerilliant
Chinese Patent Office
Citi
Healthtrust
Colorcon

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 verifification 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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