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Last Updated: September 25, 2022

ORAPRED ODT Drug Patent Profile


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Which patents cover Orapred Odt, and what generic alternatives are available?

Orapred Odt is a drug marketed by Concordia Pharms Inc and is included in one NDA.

The generic ingredient in ORAPRED ODT is prednisolone sodium phosphate. There are eighty-eight drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate profile page.

Drug patent expirations by year for ORAPRED ODT
Drug Prices for ORAPRED ODT

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Drug Sales Revenue Trends for ORAPRED ODT

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Recent Clinical Trials for ORAPRED ODT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Chulalongkorn UniversityN/A
University of FloridaPhase 4
University of California, San FranciscoPhase 4

See all ORAPRED ODT clinical trials

Pharmacology for ORAPRED ODT
Anatomical Therapeutic Chemical (ATC) Classes for ORAPRED ODT
A06AD Osmotically acting laxatives
A06A DRUGS FOR CONSTIPATION
A06 DRUGS FOR CONSTIPATION
A Alimentary tract and metabolism
A06AG Enemas
A06A DRUGS FOR CONSTIPATION
A06 DRUGS FOR CONSTIPATION
A Alimentary tract and metabolism
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
B05XA Electrolyte solutions
B05X I.V. SOLUTION ADDITIVES
B05 BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B Blood and blood forming organs
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D07AA Corticosteroids, weak (group I)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XA Corticosteroids, weak, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs
V03AG Drugs for treatment of hypercalcemia
V03A ALL OTHER THERAPEUTIC PRODUCTS
V03 ALL OTHER THERAPEUTIC PRODUCTS
V Various
Paragraph IV (Patent) Challenges for ORAPRED ODT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ORAPRED ODT Orally Disintegrating Tablets prednisolone sodium phosphate 10 mg, 15 mg and 30 mg 021959 1 2010-07-22

US Patents and Regulatory Information for ORAPRED ODT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-001 Jun 1, 2006 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-002 Jun 1, 2006 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-003 Jun 1, 2006 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 ORAPRED ODT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-003 Jun 1, 2006 See Plans and Pricing See Plans and Pricing
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-003 Jun 1, 2006 See Plans and Pricing See Plans and Pricing
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-001 Jun 1, 2006 See Plans and Pricing See Plans and Pricing
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-002 Jun 1, 2006 See Plans and Pricing See Plans and Pricing
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-001 Jun 1, 2006 See Plans and Pricing See Plans and Pricing
Concordia Pharms Inc ORAPRED ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING;ORAL 021959-001 Jun 1, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ORAPRED ODT

See the table below for patents covering ORAPRED ODT around the world.

Country Patent Number Title Estimated Expiration
Australia 1922000 See Plans and Pricing
Hong Kong 1146901 See Plans and Pricing
European Patent Office 0975336 See Plans and Pricing
European Patent Office 0494972 PRESENTATION SOUS FORME EFFERVESCENTE D'UN MEDICAMENT A USAGE PEDIATRIQUE (EFFERVESCENT DOSAGE FORM AND METHOD OF ADMINISTERING SAME) See Plans and Pricing
World Intellectual Property Organization (WIPO) 9846215 See Plans and Pricing
Canada 2061917 FORME POSOLOGIQUE EFFERVESCENTE POUR ENFANTS (PEDIATRIC EFFERVESCENT DOSAGE FORM) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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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 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.