MEROPENEM Drug Research via One Search

Drug Market Analysis

Labels - Marketing Product 16

Approvals - Approved FDA Filings 10

API - Active Pharmaceutical Ingredients Filings 10

Tentative Approvals 0

There are 16 marketed drugs that starts with meropenem leveraging 10 FDA filings. To produce the drug products meropenem there are 10 registered Active Pharmacuetical Ingredients (APIs). There is also currently 0 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 meropenem include ACS DOBFA AMNEAL PH AUROMEDIC B. BRAUN BLUEPOINT CIVICA, I DAEWOONG FRESENIUS GLAND PHA HOSPIRA, MELINTA T PFIZER LA SANDOZ IN SAVIOR LI WG CRITIC XELLIA PH based on the returned terms: MEROPENEM AND SODIUM CHLORIDE MEROPENEM MEROPENEM-VABORBACTAM

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Active FDA approvals for the search meropenem exist for ACS DOBFAR AMNEAL PHA AUROBINDO B BRAUN ME DAEWOONG P GLAND HQ SPCLT P PFIZER REMPEX SAVIOR LIF based on the returned terms: MEROPENEM MEROPENEM; VABORBACTAM

Go to FDA Approvals for meropenem

APIs filings returned based on the search term meropenem are ACS DOBFAR S AUROBINDO PH EUGIA PHARMA SAVIOR LIFET SHANDONG ANH SHENZHEN HAI STERILE INDI SUMITOMO DAI SUZHOU HOMES UNIMARK REME based on the returned terms: MEROPENEM MEROPENEM BULK BLEND Meropenem USP MEROPENEM AND SODIUM CARBONATE MEROPENEM FOR INJECTION MEROPENEM FOR INJECTION STERIL MEROPENEM STERILE MEROPENEM TECHNICAL MEROPENEM (NON-STERILE DRUG SU MEROPENEM FOR INJECTION (STERI MEROPENEM USP (STERILE) MEROPENEM WITH SODIUM CARBONAT MEROPENEM FOR INJECTION USP MEROPENEM TRIHYDRATE STERILE MEROPENEM TRIHYDRATE NON STERI

Go to API Details for meropenem Go to API Details for meropenem

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 did not find any tentative approvals for the search meropenem

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 Schien (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... savior acs dob

Drug Supply Analysis

FDA Shortages - Listings on FDA Shortage List 0

Recalls - Recalls on product (abridged) 0

483s - Drug Mentioned in 483s 12

Compounders - Compounders Making This Drug 0

How Made - Report on Manufacturing Process 0

Drug supply is evaluated upon many factors from current status and process to manufacture. meropenem has 0 listings on the FDA drug shortage list. In addition, there are 0 recalls on file for meropenem. Another area of interest could be if meropenem is mentioned in any FDA 483s. meropenem is mentioned in 12 483s. Also, to meet patient needs it appears there are 0 compounded forms of meropenem. To see more information on how is made we do have access to 0 production files out of Europe which could be a good proxy for production.

There were no FDA drug shortage listings for your the search meropenem .

Recalling firms and dates include We were not able to locate and drug recalls for the search meropenem . Our database reflects that of the publically available FDA recalls but that list is not comprehensive

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 ALEXANDER INFUSION, LLC DBA AVANTI HEALTH CARE SERVICES CORAM HEALTHCARE CORP. FRANCK'S LAB INC DBA TRINITY CARE SOLUTIONS I.V. SPECIALTY LTD. I.V. SPECIALTY LTD. INFUSCIENCE, INC. DBA BIOSCRIP INFUSION SERVICES INFUSION OPTIONS, INC. LINCARE, INC. LINCARE, INC. PHARMSCRIPT, LLC SENTARA ENTERPRISES SENTARA ENTERPRISES DBA SENTARA HOME INFUSION PHARMACY SERVICES

See the 483s for meropenem See the 483s for meropenem

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 not able to locate any compounders of product for this search.

One method to access manufactuing process is to use filings out of Europe which publish manufacturing data. We were not able to locate any of these reports for this search.

Drug Exclusivity Analysis

Patents - Drug Patents 6

Exclusivity - FDA Exclusivity 2

PIV - Paragraph IV Drug Files 0

Drug exclusivity for meropenem is evaluated based on Orange Book Patents, Paragraph IV filings and FDA Exclusivity. Currently there are 6 orange book patents, 2 FDA exclusivities and 0 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).

We were able to locate the following drug exclusivities which you can click to see the drug patent details. REMPEX, VABOMERE, 1GM/VIAL;1GM/VIAL, NCE:NEW CHEMICAL ENTITY, 2022-08-29 REMPEX, VABOMERE, 1GM/VIAL;1GM/VIAL, GAIN:GENERATING ANTIBIOTIC INCENTIVES NOW, 2027-08-29

We were not able to locate any paragraph four (PIV) drug patent statuses for this search meropenem

Drug Partnership Analysis

Shared Filings 3

GPO/Private Labels Identified 4

Often pharmaceutical filings are shared by many marketing organizations and not just virtual pharma companies. There are 3 companies sharing FDA filngs and we have been able to trace back GPO / private labes for 4 filings for meropenem . See details in the tabs to the right

We have been able to locate that there are 3 shared filings for the search meropenem

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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 Schien (HF or GI)

Go To More Details on meropenem Marketers Go To More Details on meropenem Marketers
Drug Pricing Analysis

FSS - Federal Supply Schedule Pricing 5

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 5 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 Fresenius Kabi, LLC Golden State Medical Supply, Inc. Hospira Worldwide, LLC Melinta Therapeutics, LLC Pfizer, Inc.

Go To FSS Details on meropenem 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 meropenem .

Drug Promotions Analysis

Advertising - Available Relevant Ads 1

Warnings - Product Warning and Precautions Coming soon

We have 1 promotional materials for the search meropenem . Promotional ads are highly regulated and based off of OpenFDA this product has specific warnings and risks called out.

We have pharmaceutical ads on file for WG Critical Care, Meropenem, Reminder ad

Go To Drug Ads for meropenem Marketers Go To Drug Ads for meropenem Marketers