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 ENDO OPERATIONS on August 18th, 2014.
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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: | 312 |
| Patent Applications: | 222 |
| 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 |
|---|---|
| Boston Medical Center | Phase 4 |
| Ain Shams University | Phase 4 |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Phase 4 |
Pharmacology for PRECEDEX
| Drug Class | Central alpha-2 Adrenergic Agonist |
| Mechanism of Action | Adrenergic alpha2-Agonists |
| Physiological Effect | General Anesthesia |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dexmedetomidine premix formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dexmedetomidine premix formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting PRECEDEX
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-003 | Mar 13, 2013 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-003 | Mar 13, 2013 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-004 | Nov 14, 2014 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-004 | Nov 14, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-001 | Dec 17, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-001 | Dec 17, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Canada | 2806706 | ⤷ Sign Up | |
| South Korea | 101632103 | ⤷ Sign Up | |
| Israel | 224867 | Dexmedetomidine premix formulation | ⤷ Sign Up |
| Germany | 10399005 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PRECEDEX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0300652 | 7/2003 | Austria | ⤷ Sign Up | PRODUCT NAME: DEXMEDETOMIDIN HYDROCHLORID; REGISTRATION NO/DATE: EU/2/02/033/001 20020830 |
| 0300652 | 300117 | Netherlands | ⤷ Sign Up | 300117, 20080708, EXPIRES: 20130707 |
| 0300652 | SPC/GB03/005 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: D-MEDETOMIDINE (4-((1S)-1-(2,3-DIMETHYLPHENYL)ETHYL)-1H-IMIDAZOLE) AND ITS NON-TOXIC PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE HYDROCHLORIDE; REGISTERED: UK EU/2/02/033/001 20020830 |
| 0300652 | C300117 | Netherlands | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & 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 verification 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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