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Serving leading biopharmaceutical companies globally:

US Department of Justice
McKesson
Federal Trade Commission
Fish and Richardson
US Army
Covington
Cerilliant
Dow
Colorcon
Farmers Insurance

Generated: October 18, 2017

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 six 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-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for NDA: 205831

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:6
Therapeutic Class:Central Nervous System Agents
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Apr 17, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 17, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:► SubscribePatent Expiration:Dec 16, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Dec 16, 2019Product Flag?YSubstance Flag?Delist Request?


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Serving leading biopharmaceutical companies globally:

Healthtrust
Johnson and Johnson
Teva
US Army
Express Scripts
Chinese Patent Office
UBS
AstraZeneca
Cerilliant
Argus Health

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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