Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 6, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205831

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NDA 205831 describes APTENSIO XR, which is a drug marketed by Rhodes Pharms and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug and four Paragraph IV challenges. Additional details are available on the APTENSIO XR profile page.

The generic ingredient in APTENSIO XR is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for 205831
Tradename:APTENSIO XR
Applicant:Rhodes Pharms
Ingredient:methylphenidate hydrochloride
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 205831
Suppliers and Packaging for NDA: 205831
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831 NDA Rhodes Pharmaceuticals L.P. 42858-401 42858-401-45 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-401-45)
APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831 NDA Rhodes Pharmaceuticals L.P. 42858-402 42858-402-45 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-402-45)
Paragraph IV (Patent) Challenges for 205831
Tradename Dosage Ingredient NDA Submissiondate
APTENSIO XR CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 205831 2015-12-24
APTENSIO XR CAPSULE, EXTENDED RELEASE;ORAL methylphenidate hydrochloride 205831 2015-12-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Apr 17, 2015TE:AB3RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 16, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Jun 16, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Jun 16, 2020Product Flag?Substance Flag?Delist Request?Y

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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Harvard Business School
Express Scripts
Boehringer Ingelheim
Merck

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