DEXMEDETOMIDINE Drug Research via One Search

Drug Market Analysis

Labels - Marketing Product 27

Approvals - Approved FDA Filings 22

API - Active Pharmaceutical Ingredients Filings 11

Tentative Approvals 1

There are 27 marketed drugs that starts with dexmedetomidine leveraging 22 FDA filings. To produce the drug products dexmedetomidine there are 11 registered Active Pharmacuetical Ingredients (APIs). There is also currently 1 tentative approval(s) which could be another future market entrant. The full list of this data can be seen here with an exportable excel file and easy access to the product insert and product labels. Our data is sourced through a combination of openFDA, orangebook and proprietary linking logic.
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The marketing companies and product returned from the search dexmedetomidine include ACCORD HE ACTAVIS I AKORN, IN AMNEAL PH ATHENEX P AUROMEDIC BAXTER HE CADILA HE DR.REDDY' FRESENIUS GENERAL I GLAND PHA HIKMA PHA HOSPIRA, MEDICAL P MEITHEAL MYLAN INS PAR PHARM PIRAMAL C PRECISION SANDOZ IN SLAYBACK SUN PHARM TAGI PHAR TEVA PHAR WG CRITIC ZYDUS PHA based on the returned terms: DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HCL DEXMEDETOMIDINE DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

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Active FDA approvals for the search dexmedetomidine exist for ACCORD HLT ACTAVIS IN AKORN INC AMNEAL PHA AUROBINDO BAXTER HLT FRESENIUS GLAND PHAR HIKMA HOSPIRA HQ SPCLT P JIANGSU HE MYLAN INST MYLAN LABS PAR STERIL SANDOZ INC SLAYBACK P SUN PHARM TAGI TEVA PHARM WEST-WARD ZYDUS PHAR based on the returned terms: DEXMEDETOMIDINE HYDROCHLORIDE

Go to FDA Approvals for dexmedetomidine

APIs filings returned based on the search term dexmedetomidine are ALCAMI WISCO ASYMCHEM LAB CHEMWERTH IN EDMOND PHARM EMCURE PHARM FERMION OY GLAND PHARMA INTERQUIM SA JIANGSU HENG MOEHS IBERIC RELIABLE BIO based on the returned terms: DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HCI DEXMEDETOMIDINE HCL

Go to API Details for dexmedetomidine Go to API Details for dexmedetomidine

Tentative approvals are typically a filing that is ready to approve but waiting for a patent or exclusivity period to expire prior to approval. Information on tentatively approved drug can inform pharma companies of future entrants that may impact thier go to market staregy or inform business development experts of companies that may be looking for a partner to bring a tentatively approved drug to the market.

We where able to find the following tentative approvals based on the search dexmedetomidine . FRESENIUS KABI USA, DEXMEDETOMIDINE HYDROCHLORIDE, EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML), INJECTABLE;INJECTION

We have been able to locate the private label and GPO suppliers for the following highlighted labels. Click on the details to see the private label supplier

BluePoint Civica Intalere Northstar NovaPlus Premier Schein (HF or GI)

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Vertically integrated analysis is completed by searchong for companies with the FDA approved drug filings and an API (Drug Master Filings) on record. That list includes... gland p

Drug Supply Analysis

FDA Shortages - Listings on FDA Shortage List 14

Recalls - Recalls on product (abridged) 3

483s - Drug Mentioned in 483s 4

Compounders - Compounders Making This Drug 1

How Made - Report on Manufacturing Process 2

Drug supply is evaluated upon many factors from current status and process to manufacture. dexmedetomidine has 14 listings on the FDA drug shortage list. In addition, there are 3 recalls on file for dexmedetomidine. Another area of interest could be if dexmedetomidine is mentioned in any FDA 483s. dexmedetomidine is mentioned in 4 483s. Also, to meet patient needs it appears there are 1 compounded forms of dexmedetomidine. To see more information on how is made we do have access to 2 production files out of Europe which could be a good proxy for production.

There are a total of 14 drug shortage listings for dexmedetomidine . Of those listings 13 are listed as current drug shortages while 0 are listed as resolved and 1 listed as to be discontinued.

Go To dexmedetomidine Drug Shortage Details Go To dexmedetomidine Drug Shortage Details

Recalling firms and dates include CMC ENTERPRISE PHARMACY, 20190501 FRESENIUS KABI USA, LLC, 20200902 FRESENIUS KABI USA, LLC, 20201216

FDA 483 forms are the forms to close out inspections and they note any FDA observations. Wizmed performs word searched of common words and drug names within 483s on file. We were able to idendifty the following 483s that mention this drug from HOSPIRA HOSPIRA INC, A PFIZER COMPANY HOSPIRA INC. HOSPIRA INC. A PFIZER COMPANY

See the 483s for dexmedetomidine See the 483s for dexmedetomidine

Compounders, often reffered to as 503b compounders, prepare and modify drugs to be in a more final form for use by health care practitioners and patients. We were able to locate the following compounders for this search. ATLAS PHARMACEU

Go To Compounders for dexmedetomidine Go To Compounders for dexmedetomidine

One method to access manufactuing process is to use filings out of Europe which publish manufacturing data. filings we were able to locate are for the following company(s) Orion Corporation Accord Healthcare S.L.U.

Go To Manufacturing Reports Go To Manufacturing Reports
Drug Exclusivity Analysis

Patents - Drug Patents 15

Exclusivity - FDA Exclusivity 0

PIV - Paragraph IV Drug Files 3

Drug exclusivity for dexmedetomidine is evaluated based on Orange Book Patents, Paragraph IV filings and FDA Exclusivity. Currently there are 15 orange book patents, 0 FDA exclusivities and 3 paragraph IV filings. Further analysis can be seen in the additional tabs

The FDA offers drug exclusivities for products such as Orphan Drug Exclusivity (ODE) – 7 years, New Chemical Entity Exclusivity (NCE) – 5 years, Generating Antibiotic Incentives Now (GAIN) Exclusivity – 5 years added to certain exclusivities, New Clinical Investigation Exclusivity – 3 years, Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity, Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only), Competitive Generic Therapy (CGT) - 180 days (this exclusivity is for ANDAs only).

There were no FDA exclusivities located for the serach dexmedetomidine

Precedex 21038 (Dexmedetomidine Injection 100 mcg/mL) had a patent submission date of 2009-04-08 and has a current 180 day status of _ Eligible. There are _1 ANDAs submitted. The date of the last PIV qualifying patent is _ 2019-03-31. The date of the first applicant approval is _2016-06-14.

Precedex 21038 (Dexmedetomidine Injection 4 mcg/mL, 50 mL and 100 mL vials) had a patent submission date of 2013-12-26 and has a current 180 day status of _ Extinguished. There are _1 ANDAs submitted. The date of the last PIV qualifying patent is _ 2032-01-04. The date of the first applicant approval is _2020-01-30.
Precedex 21038 (Dexmedetomidine Injection 4 mcg/mL, 20 mL vials) had a patent submission date of 2015-09-30 and has a current 180 day status of _ Eligible. There are _1 ANDAs submitted. The date of the last PIV qualifying patent is _ 2023-01-04. The date of the first applicant approval is _2018-11-29.

Drug Partnership Analysis

Shared Filings 9

GPO/Private Labels Identified 2

Often pharmaceutical filings are shared by many marketing organizations and not just virtual pharma companies. There are 9 companies sharing FDA filngs and we have been able to trace back GPO / private labes for 2 filings for dexmedetomidine . See details in the tabs to the right

We have been able to locate that there are 9 shared filings for the search dexmedetomidine

Go To Shared Filings for dexmedetomidine Marketers Go To Shared Filings for dexmedetomidine Marketers

We have been able to locate the private label and GPO suppliers for the following highlighted labels. Click on the details to see the private label supplier

BluePoint Civica Intalere Northstar NovaPlus Premier Schein (HF or GI)

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Drug Pricing Analysis

FSS - Federal Supply Schedule Pricing 7

NADAC - National Drug Acquisition Cost 0

Pharmaceutical pricing is not very transparent. The two available sources to use are the federal supply schedule and National Average Drug Acquisition Cost, if it exists. Federal supply schedule pricing traditionally gives insight into the more accurate and lower cost of the product in the market. The prefered and more accurage source is the FSS schedule low and there are 7 vendors on the Federal Supply Schedule contract. The full table can be seen here on the FSS tab and in the detailed table. The National Average Drug Acquisition cost was located for 0 listings. The details can be seen in NADAC details.

Federal supply schedule drug pricing sets the pricing paid by the many government entities. The data is pulled daily and we have it for Baxter Healthcare Corporation Fresenius Kabi, LLC Golden State Medical Supply, Inc. Hospira Worldwide, LLC Mylan Institutional LLC Par Pharmaceutical, Inc. WG Critical Care, LLC

Go To FSS Details on dexmedetomidine Marketers

The National Average Drug Acquisition Cost or NADAC sets some key reimbursement rates of drugs.

We did not have any NADAC's for the search dexmedetomidine .

Drug Promotions Analysis

Advertising - Available Relevant Ads 0

Warnings - Product Warning and Precautions Coming soon

We have 0 promotional materials for the search dexmedetomidine . Promotional ads are highly regulated and based off of OpenFDA this product has specific warnings and risks called out.

We have no pharmaceutical ads on file for the search dexmedetomidine .