DEXMEDETOMIDINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Dexmedetomidine Hydrochloride, and what generic alternatives are available?
Dexmedetomidine Hydrochloride is a drug marketed by Accord Hlthcare, Actavis Inc, Am Regent, Amneal, Amneal Pharms Co, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hengrui Pharma, Hikma, Meitheal, Milla Pharms, Mylan Institutional, Mylan Labs Ltd, Par Sterile Products, Piramal Critical, Rising, Sandoz, Slayback Pharma Llc, Tagi, Teva Pharms Usa, Zydus Pharms, and Hq Spclt Pharma. and is included in twenty-nine NDAs. There are two patents protecting this drug.
This drug has five patent family members in five countries.
The generic ingredient in DEXMEDETOMIDINE HYDROCHLORIDE is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dexmedetomidine Hydrochloride
A generic version of DEXMEDETOMIDINE HYDROCHLORIDE was approved as dexmedetomidine hydrochloride by MYLAN INSTITUTIONAL on August 18th, 2014.
Summary for DEXMEDETOMIDINE HYDROCHLORIDE
International Patents: | 5 |
US Patents: | 2 |
Applicants: | 25 |
NDAs: | 29 |
Finished Product Suppliers / Packagers: | 26 |
Raw Ingredient (Bulk) Api Vendors: | 97 |
Clinical Trials: | 1,288 |
Patent Applications: | 222 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DEXMEDETOMIDINE HYDROCHLORIDE |
What excipients (inactive ingredients) are in DEXMEDETOMIDINE HYDROCHLORIDE? | DEXMEDETOMIDINE HYDROCHLORIDE excipients list |
DailyMed Link: | DEXMEDETOMIDINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for DEXMEDETOMIDINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University Hospital "Sestre Milosrdnice" | N/A |
Kafrelsheikh University | Phase 2 |
Kasr El Aini Hospital | N/A |
Pharmacology for DEXMEDETOMIDINE HYDROCHLORIDE
Drug Class | Central alpha-2 Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha2-Agonists |
Physiological Effect | General Anesthesia |
Medical Subject Heading (MeSH) Categories for DEXMEDETOMIDINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for DEXMEDETOMIDINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DEXMEDETOMIDINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
PRECEDEX | Injection | dexmedetomidine hydrochloride | 4 mcg/mL, 20 mL vials | 021038 | 1 | 2015-09-30 |
PRECEDEX | Injection | dexmedetomidine hydrochloride | 4 mcg/mL, 50 mL and 100 mL vials | 021038 | 1 | 2013-12-26 |
PRECEDEX | Injection | dexmedetomidine hydrochloride | 100 mcg/mL | 021038 | 1 | 2009-04-08 |
US Patents and Regulatory Information for DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDE is protected by two US patents.
Patents protecting DEXMEDETOMIDINE HYDROCHLORIDE
Heat sterilizeable, premixed, ready to use dexmedetomidine solution packaged in a flexible plastic container
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Heat sterilizeable, premixed, ready to use dexmedetomidine solution packaged in a flexible plastic container
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
International Patents for DEXMEDETOMIDINE HYDROCHLORIDE
See the table below for patents covering DEXMEDETOMIDINE HYDROCHLORIDE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2017184188 | ⤷ Try a Trial | |
South Africa | 201807466 | HEAT STERILIZEABLE, PREMIXED, READY TO USE DEXMEDETOMIDINE SOLUTION PACKAGED IN A FLEXIBLE PLASTIC CONTAINER | ⤷ Try a Trial |
Australia | 2016403510 | Heat sterilizeable, premixed, ready to use dexmedetomidine solution packaged in a flexible plastic container | ⤷ Try a Trial |
European Patent Office | 3429574 | SOLUTION DE DEXMÉDÉTOMIDINE PRÉMÉLANGÉE, PRÊTE À L'EMPLOI, STÉRILISABLE À CHAUD PRÉSENTÉE DANS UN CONTENANT EN PLASTIQUE SOUPLE (HEAT STERILIZEABLE, PREMIXED, READY TO USE DEXMEDETOMIDINE SOLUTION PACKAGED IN A FLEXIBLE PLASTIC CONTAINER) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DEXMEDETOMIDINE HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0300652 | 2003C/005 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903 |
0300652 | C300117 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DEXMEDETOMIDINE, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH IN FARMACEUTISCH OPZICHT AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZ ONDER DEXMEDETOMIDINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/2/02/033/001 20020830 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |