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Last Updated: September 25, 2022

PRECEDEX Drug Patent Profile


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When do Precedex patents expire, and what generic alternatives are available?

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 fifty-one patent family members in thirty-five countries.

The generic ingredient in PRECEDEX is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.

Drug patent expirations by year for PRECEDEX
Drug Prices for PRECEDEX

See drug prices for PRECEDEX

Recent Clinical Trials for PRECEDEX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Lawson Health Research InstitutePhase 3
Kaohsiung Veterans General Hospital.N/A
Children's Cancer Hospital Egypt 57357Phase 3

See all PRECEDEX clinical trials

Pharmacology for PRECEDEX
Anatomical Therapeutic Chemical (ATC) Classes for PRECEDEX
Paragraph IV (Patent) Challenges for PRECEDEX
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 PRECEDEX

PRECEDEX is protected by three US patents.

Patents protecting PRECEDEX

Dexmedetomidine premix formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dexmedetomidine premix formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dexmedetomidine premix formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 021038-005 Jan 31, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-003 Mar 13, 2013 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014 AP RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PRECEDEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 See Plans and Pricing See Plans and Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-004 Nov 14, 2014 See Plans and Pricing See Plans and Pricing
Hospira PRECEDEX dexmedetomidine hydrochloride INJECTABLE;INJECTION 021038-002 Mar 13, 2013 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PRECEDEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0300652 C300117 Netherlands See Plans and Pricing 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 C01069893/01 Switzerland See Plans and Pricing FORMER OWNER: ORION CORPORATION, FI
0300652 300117 Netherlands See Plans and Pricing 300117, 20080708, EXPIRES: 20130707
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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