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Serving leading biopharmaceutical companies globally:

UBS
Mallinckrodt
Covington
McKesson
Federal Trade Commission
Colorcon
US Department of Justice
Chubb
McKinsey
Citi

Generated: February 18, 2018

DrugPatentWatch Database Preview

PRECEDEX Drug Profile

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Which patents cover Precedex, and when can generic versions of Precedex launch?

Precedex is a drug marketed by Hospira and is included in one NDA. There are seven patents protecting this drug and three Paragraph IV challenges.

This drug has seventy-one patent family members in thirty-seven countries.

The generic ingredient in PRECEDEX is dexmedetomidine hydrochloride. There are thirteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
Summary for PRECEDEX
Drug patent expirations by year for PRECEDEX
Pharmacology for PRECEDEX
Medical Subject Heading (MeSH) Categories for PRECEDEX

US Patents and Regulatory Information for PRECEDEX

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 021038-004 Nov 14, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-001 Dec 17, 1999 AP RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 PRECEDEX

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

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Paragraph IV (Patent) Challenges for PRECEDEX
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Injection 4 mcg/mL, 20 mL vials ➤ Subscribe 9/30/2015
➤ Subscribe Injection 100 mcg/mL ➤ Subscribe 4/8/2009
➤ Subscribe Injection 4 mcg/mL, 50 mL and 100 mL vials ➤ Subscribe 12/26/2013

Non-Orange Book US Patents for PRECEDEX

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 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for PRECEDEX

Supplementary Protection Certificates for PRECEDEX

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

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Dow
Queensland Health
Argus Health
Johnson and Johnson
Teva
Boehringer Ingelheim
Mallinckrodt
Cerilliant

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