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-nine suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Precedex
A generic version of PRECEDEX was approved as dexmedetomidine hydrochloride by MYLAN INSTITUTIONAL on August 18th, 2014.
Summary for PRECEDEX
International Patents: | 51 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 97 |
Clinical Trials: | 308 |
Patent Applications: | 233 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for PRECEDEX |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PRECEDEX |
What excipients (inactive ingredients) are in PRECEDEX? | PRECEDEX excipients list |
DailyMed Link: | PRECEDEX at DailyMed |
Recent Clinical Trials for PRECEDEX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Samsung Medical Center | N/A |
Korea Institute of Science and Technology | N/A |
Assiut University | N/A |
Pharmacology for PRECEDEX
Drug Class | Central alpha-2 Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha2-Agonists |
Physiological Effect | General Anesthesia |
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 and one FDA Regulatory Exclusivity.
Patents protecting PRECEDEX
Dexmedetomidine premix formulation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dexmedetomidine premix formulation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dexmedetomidine premix formulation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting PRECEDEX
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-003 | Mar 13, 2013 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-003 | Mar 13, 2013 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-004 | Nov 14, 2014 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-004 | Nov 14, 2014 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
>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 | 021038-001 | Dec 17, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-003 | Mar 13, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-004 | Nov 14, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-001 | Dec 17, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-002 | Mar 13, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PRECEDEX
See the table below for patents covering PRECEDEX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | 201332546 | Dexmedetomidine premix formulation | ⤷ Try a Trial |
Czech Republic | 301013 | Lécivo pro sedaci kriticky nemocného pacienta (Medicament for sedating a patient while in the intensive care unit) | ⤷ Try a Trial |
Denmark | 165788 | ⤷ Try a Trial | |
Japan | 2002509880 | ⤷ Try a Trial | |
Slovakia | 14362000 | Liečivo na sedáciu na jednotke intenzívnej starostlivosti (USE OF DEXMEDETOMIDINE FOR ICU SEDATION) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PRECEDEX
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 |
0300652 | 7/2003 | Austria | ⤷ Try a Trial | PRODUCT NAME: DEXMEDETOMIDIN HYDROCHLORID; REGISTRATION NO/DATE: EU/2/02/033/001 20020830 |
1069893 | C01069893/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: ORION CORPORATION, FI |
0300652 | 300117 | Netherlands | ⤷ Try a Trial | 300117, 20080708, EXPIRES: 20130707 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |