.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

APTENSIO XR Drug Profile

« Back to Dashboard
Aptensio Xr 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.

This drug has twenty-four patent family members in twelve countries.

The generic ingredient in APTENSIO XR is methylphenidate hydrochloride. There are thirty-one drug master file entries for this compound. Thirty-five suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for Tradename: APTENSIO XR

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: APTENSIO XR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rhodes Pharms
APTENSIO XR
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL205831-006Apr 17, 2015RXNo7,438,930► subscribeYY ► subscribe
Rhodes Pharms
APTENSIO XR
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL205831-005Apr 17, 2015RXNo9,066,869► subscribeY ► subscribe
Rhodes Pharms
APTENSIO XR
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL205831-007Apr 17, 2015RXYes► subscribe► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV activity for: APTENSIO XR

Drugname Dosage Strength RLD Submissiondate
methylphenidate hydrochlorideExtended-release Capsules30 mgAptensio XR3/28/2016
methylphenidate hydrochlorideExtended-release Capsules15 mg, 20 mg, 40 mg and 50 mgAptensio XR12/28/2015
methylphenidate hydrochlorideExtended-release Capsules10 mgAptensio XR12/24/2015
methylphenidate hydrochlorideExtended-release Capsules60 mgAptensio XR12/23/2015

Non-Orange Book Patents for Tradename: APTENSIO XR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,673,367 Controlled/modified release oral methylphenidate formulations► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: APTENSIO XR

Country Document Number Estimated Expiration
Japan4663880► subscribe
Spain2224740► subscribe
Denmark1140088► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

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

How are People Using DrugPatentWatch?

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.

`abc