Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Express Scripts
Deloitte
Cipla
Accenture
McKesson
Moodys
Cantor Fitzgerald
Queensland Health

Generated: November 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210951

« Back to Dashboard

NDA 210951 describes ERLEADA, which is a drug marketed by Janssen Biotech and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ERLEADA profile page.

The generic ingredient in ERLEADA is apalutamide. One supplier is listed for this compound. Additional details are available on the apalutamide profile page.
Summary for 210951
Tradename:ERLEADA
Applicant:Janssen Biotech
Ingredient:apalutamide
Patents:6
Generic Entry Opportunity Date for 210951
Generic Entry Date for 210951*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 210951
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERLEADA apalutamide TABLET;ORAL 210951 NDA Janssen Products, LP 59676-600 59676-600-12 120 TABLET, FILM COATED in 1 BOTTLE (59676-600-12)
ERLEADA apalutamide TABLET;ORAL 210951 NDA Janssen Products, LP 59676-600 59676-600-99 120 TABLET, FILM COATED in 1 BOTTLE (59676-600-99)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Feb 14, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 14, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Sep 23, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT IN COMBINATION WITH A GNRH AGONIST OF HIGH RISK NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)
Patent:➤ Try a Free TrialPatent Expiration:Sep 23, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT IN COMBINATION WITH A GNRH AGONIST OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Fuji
Express Scripts
McKesson
Merck
Queensland Health
Harvard Business School
AstraZeneca
Daiichi Sankyo

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.