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-four 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 PANGEA on April 28th, 1983.
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Questions you can ask:
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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: | 5,937 |
| Drug Prices: | Drug price information for HEMADY |
| What excipients (inactive ingredients) are in HEMADY? | HEMADY excipients list |
| DailyMed Link: | HEMADY at DailyMed |
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 |
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.
| 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 | 11,304,961 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Dexcel | HEMADY | dexamethasone | TABLET;ORAL | 211379-001 | Oct 3, 2019 | RX | Yes | Yes | 10,537,585 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Dexcel | HEMADY | dexamethasone | TABLET;ORAL | 211379-001 | Oct 3, 2019 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >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/001140Ozurdex 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/004071Treatment 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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2019123453 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for HEMADY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1429780 | 13C0012 | France | ⤷ Start Trial | 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 |
| 1429780 | SPC/GB12/058 | United Kingdom | ⤷ Start Trial | 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 | ⤷ Start Trial | PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
DrugChatter Q&A for HEMADY
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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