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Serving leading biopharmaceutical companies globally:

AstraZeneca
Novartis
Healthtrust
Deloitte
UBS
Mallinckrodt
US Department of Justice
US Army
Johnson and Johnson
Argus Health

Generated: January 18, 2018

DrugPatentWatch Database Preview

APTENSIO XR Drug Profile

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Which patents cover Aptensio Xr, and when can generic versions of Aptensio Xr launch?

Aptensio Xr is a drug marketed by Rhodes Pharms and is included in one NDA. There are six patents protecting this drug and four Paragraph IV challenges.

This drug has thirty-seven patent family members in fourteen 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. Additional details are available on the methylphenidate hydrochloride profile page.
Summary for APTENSIO XR
Drug patent expirations by year for APTENSIO XR
Pharmacology for APTENSIO XR

US Patents and Regulatory Information for APTENSIO XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-006 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-005 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-007 Apr 17, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-007 Apr 17, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-004 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-005 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-005 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-001 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-003 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Rhodes Pharms APTENSIO XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 205831-004 Apr 17, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for APTENSIO XR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Capsules 10 mg ➤ Subscribe 12/24/2015
➤ Subscribe Extended-release Capsules 15 mg, 20 mg, 40 mg and 50 mg ➤ Subscribe 12/28/2015
➤ Subscribe Extended-release Capsules 30 mg ➤ Subscribe 3/28/2016
➤ Subscribe Extended-release Capsules 60 mg ➤ Subscribe 12/23/2015

Non-Orange Book US Patents for 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
9,801,823 Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations ➤ Subscribe
6,673,367 Controlled/modified release oral methylphenidate formulations ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for APTENSIO XR

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Serving leading biopharmaceutical companies globally:

Dow
Fish and Richardson
AstraZeneca
Farmers Insurance
Cantor Fitzgerald
Chubb
Novartis
Express Scripts
Deloitte

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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