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Serving leading biopharmaceutical companies globally:

Merck
Moodys
US Department of Justice
Chubb
Mallinckrodt
Baxter
Cantor Fitzgerald
Boehringer Ingelheim
QuintilesIMS
Argus Health

Generated: January 20, 2018

DrugPatentWatch Database Preview

Dexmedetomidine hydrochloride - Generic Drug Details

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What are the generic sources for dexmedetomidine hydrochloride and what is the scope of dexmedetomidine hydrochloride freedom to operate?

Dexmedetomidine hydrochloride
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Actavis Inc, Akorn Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Jiangsu Hengrui Med, Luitpold Pharms Inc, Mylan Institutional, Par Sterile Products, Sandoz Inc, Sun Pharm Inds Inc, West-ward Pharms Int, Hospira, and Hq Spclt Pharma, and is included in fourteen NDAs. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dexmedetomidine hydrochloride has seventy-one patent family members in thirty-seven countries.

There are thirteen drug master file entries for dexmedetomidine hydrochloride. Thirteen suppliers are listed for this compound.
Summary for dexmedetomidine hydrochloride
Pharmacology for dexmedetomidine hydrochloride
Medical Subject Heading (MeSH) Categories for dexmedetomidine hydrochloride

US Patents and Regulatory Information for dexmedetomidine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sandoz Inc DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 091465-001 Jun 14, 2016 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mylan Institutional DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 202881-001 Aug 18, 2014 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Akorn Inc DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 202585-001 Nov 24, 2014 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
West-ward Pharms Int DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 205046-001 Apr 26, 2017 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for dexmedetomidine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 ➤ Subscribe ➤ Subscribe
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 ➤ Subscribe ➤ Subscribe
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 ➤ Subscribe ➤ Subscribe
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for dexmedetomidine hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,436,033 Methods of treatment using a dexmedetomidine premix formulation ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for dexmedetomidine hydrochloride

Supplementary Protection Certificates for dexmedetomidine hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1069893/01 Switzerland ➤ Subscribe FORMER OWNER: ORION CORPORATION, FI
03C/005 Belgium ➤ Subscribe PRODUCT NAME: CHLORHYDRATE DE DEXMEDETOMIDINE; REGISTRATION NO/DATE: EU/2/02/033/001 20020903
00117 Netherlands ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Citi
Colorcon
Chubb
Fuji
Covington
Medtronic
QuintilesIMS
Cipla

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.

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