.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Dexmedetomidine hydrochloride - Generic Drug Details

« Back to Dashboard
Dexmedetomidine hydrochloride is the generic ingredient in two branded drugs marketed by Accord Hlthcare Inc, Sun Pharm Inds Inc, Hq Spclt Pharma, Hospira, Sandoz Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Par Sterile Products, Mylan Institutional, and Akorn Inc, and is included in ten NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-four patent family members in twenty-seven countries.

There are twelve drug master file entries for dexmedetomidine hydrochloride. Nine suppliers are listed for this compound.

Summary for Generic Name: dexmedetomidine hydrochloride

Tradenames:2
Patents:5
Applicants:10
NDAs:10
Drug Master File Entries: see list12
Suppliers / Packaging: see list9
Drug Prices:see low prices

Pharmacology for Ingredient: dexmedetomidine hydrochloride

Clinical Trials for: dexmedetomidine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-003Mar 13, 2013RXYesDec 17, 2016
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-001Dec 17, 1999RXYesJun 17, 2016
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-002Mar 13, 2013RXYes8,338,470*PEDJul 4, 2032Y
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: dexmedetomidine hydrochloride

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-001Dec 17, 19995,344,840<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-003Mar 13, 20134,910,214*PED<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038-002Mar 13, 20134,910,214*PED<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: dexmedetomidine hydrochloride

Country Document Number Estimated Expiration
Germany69934305<disabled in preview>
Japan4606581<disabled in preview>
Hungary229162<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: DEXMEDETOMIDINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00117Netherlands<disabled>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
1069893/01Switzerland<disabled>PRODUCT NAME: DEXMEDETOMIDIN; REGISTRATION NO/DATE: SWISSMEDIC 62183 25.10.2012
03C/005Belgium<disabled>PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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 verifification 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.

`abc