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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

US Department of Justice
UBS
Mallinckrodt
Fish and Richardson
Queensland Health
Chubb
Colorcon
Fuji
Julphar
Farmers Insurance

Generated: November 19, 2017

Glossary

Applicant
The firm holding legal responsibility for the new drug application.

Trade Name
The trade name of the product as shown on the labeling.

Generic Name / Ingredient
The active ingredient(s) for the product. Multiple ingredients are in alphabetical order separated by a semicolon.

New Drug Application (NDA) Number
The FDA-assigned number to the application.

Product Number
The FDA-assigned number to identify the application products. Each strength is a separate product.

Approval Date
The date the product was approved as stated in the FDA approval letter to the applicant.

Type
The group or category of approved drugs; RX, OTC, or DISCN.

Reference Listed Drug (RLD)
The pioneer or innovator of the drug. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. The RLD must be a listed drug approved under section 505(c) of the FD&C Act based on a demonstration of safety and effectiveness.

Reference Standard (RS)
The previously approved drug selected by FDA that an applicant must use in the conduct of in vivo bioequivalence studies required for approval of an ANDA. The reference standard may or may not be the same listed drug as the RLD.

Drug Product Flag
Patents listed after August 18, 2003 may have a drug product flag indicating the sponsor submitted the patent as claiming the drug product. The FDA defines a drug product as a finished dosage form, for example, tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients

Drug Substance Flag
Patents listed after August 18, 2003 may have a drug substance flag indicating the sponsor submitted the patent as claiming the drug substance. The FDA defines a drug substance as an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

Patent Delist Request Flag
Sponsor has requested patent be delisted.  This patent has remained listed because a first applicant may retain eligibility for 180-day exclusivity based on a paragraph IV certification. 

Patent Number
Patent numbers as submitted to the FDA by the applicant, who may not be the patent-assignee.  A '*PED' tag indicates pediatric exclusivity granted by the FDA. 

Patent Expiration Date
The date the patent expires as submitted by the applicant holder, including applicable extensions.  A '*PED' tag indicates pediatric exclusivity granted by the FDA. 

Dosage form; Route of Administration
The product dosage form and route separated by a semi-colon. 

Strength
The potency of the active ingredient.  May repeat for multiple part products.

Therapeutic Equivalence (TE) Code
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

The two basic categories into which multisource drugs have been placed are indicated by the first letter as follows:

Patented / Exclusive Use
Designation to designate exclusivity granted to a drug product. 

Exclusivity Expiration Date
The date the exclusivity expires.

Tentative Approval
If a generic drug product is ready for approval before the expiration of any patents or exclusivities, the FDA issues a tentative approval letter to the applicant. Final approval of the generic drug product is delayed until all patent or exclusivity issues have been resolved. A tentative approval does not allow the applicant to market the generic drug product.

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Serving leading biopharmaceutical companies globally:

Citi
Mallinckrodt
Chubb
McKesson
Merck
Cerilliant
Chinese Patent Office
AstraZeneca
McKinsey
Express Scripts

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 verifification 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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