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 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. Forty-two 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 KEY THERAP on April 28^th, 1983.

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Summary for HEMADY

International Patents:	1
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	43
Patent Applications:	4,440
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for HEMADY
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

Sponsor	Phase
Mayo Clinic	Phase 1
City of Hope Medical Center	Phase 1
Southwest Oncology Group	Phase 3

See all HEMADY clinical trials

Pharmacology for HEMADY

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Compositions comprising dexamethasone
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dexcel	HEMADY	dexamethasone	TABLET;ORAL	211379-001	Oct 3, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Dexcel	HEMADY	dexamethasone	TABLET;ORAL	211379-001	Oct 3, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Dexcel	HEMADY	dexamethasone	TABLET;ORAL	211379-001	Oct 3, 2019		RX	Yes	Yes	⤷ 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

EU/EMA Drug Approvals for HEMADY

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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
THERAVIA	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

International Patents for HEMADY

See the table below for patents covering HEMADY around the world.

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019123453		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for HEMADY

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	13C0012	France	⤷ Sign Up	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
1581193	SPC/GB12/047	United Kingdom	⤷ Sign Up	PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
1429780	SPC/GB12/058	United Kingdom	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description