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Last Updated: August 11, 2022

HEMADY Drug Patent Profile


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When do Hemady patents expire, and when can generic versions of Hemady launch?

Hemady is a drug marketed by Dexcel Pharma and is included in one NDA. There are two patents protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in HEMADY is dexamethasone. There are thirty-nine drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Hemady

A generic version of HEMADY was approved as dexamethasone by XSPIRE PHARMA on April 28th, 1983.

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Summary for HEMADY
International Patents:1
US Patents:2
Applicants:1
NDAs:1
Clinical Trials: 33
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in HEMADY?HEMADY excipients list
DailyMed Link:HEMADY at DailyMed
Drug patent expirations by year for HEMADY
Recent Clinical Trials for HEMADY

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

SponsorPhase
Southwest Oncology GroupPhase 2/Phase 3
National Cancer Institute (NCI)Phase 2/Phase 3
Emory UniversityPhase 2

See all HEMADY clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for HEMADY
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D07AB Corticosteroids, moderately potent (group II)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XB Corticosteroids, moderately potent, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D10AA Corticosteroids, combinations for treatment of acne
D10A ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10 ANTI-ACNE 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

US Patents and Regulatory Information for HEMADY

HEMADY is protected by two US patents and one FDA Regulatory Exclusivity.

Patents protecting HEMADY

Compositions comprising dexamethasone
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions comprising dexamethasone
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING ADULTS WITH MULTIPLE MYELOMA USING DEXAMETHASONE IN COMBINATION WITH AN ANTI-MYELOMA PRODUCT

FDA Regulatory Exclusivity protecting HEMADY

INDICATED IN COMBINATION WITH OTHER ANTI-MYELOMA PRODUCTS FOR THE TREATMENT OF ADULTS WITH MULTIPLE MYELOMA (MM)
Exclusivity Expiration: 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
Dexcel Pharma HEMADY dexamethasone TABLET;ORAL 211379-001 Oct 3, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Dexcel Pharma HEMADY dexamethasone TABLET;ORAL 211379-001 Oct 3, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Dexcel Pharma HEMADY dexamethasone TABLET;ORAL 211379-001 Oct 3, 2019 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

EU/EMA Drug Approvals for HEMADY

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
AbbVie Deutschland GmbH & Co. KG Ozurdex dexamethasone EMEA/H/C/001140
Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO)., , Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis., , Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.,
Authorised no no no 2010-07-26
Laboratoires CTRS  Neofordex dexamethasone EMEA/H/C/004071
Treatment of multiple myeloma.
Authorised no no no 2016-03-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for HEMADY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 SPC/GB12/058 United Kingdom See Plans and Pricing PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
1581193 SPC/GB12/047 United Kingdom See Plans and Pricing PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
1429780 13C0012 France See Plans and Pricing PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Baxter
Boehringer Ingelheim
McKesson
AstraZeneca
Harvard Business School

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