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Last Updated: March 31, 2020

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ADDERALL XR 5 Drug Profile


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Which patents cover Adderall Xr 5, and what generic alternatives are available?

Adderall Xr 5 is a drug marketed by Shire and is included in one NDA. There are four patents protecting this drug.

This drug has ten patent family members in eight countries.

The generic ingredient in ADDERALL XR 5 is amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.

US ANDA Litigation and Generic Entry Outlook for Adderall Xr 5

Indicators of Generic Entry

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Summary for ADDERALL XR 5
International Patents:10
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 5
Bulk Api Vendors: 1
Clinical Trials: 36
Formulation / Manufacturing:see details
DailyMed Link:ADDERALL XR 5 at DailyMed
Drug patent expirations by year for ADDERALL XR 5
Recent Clinical Trials for ADDERALL XR 5

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SponsorPhase
Jeffrey NewcornPhase 4
National Institute on Drug Abuse (NIDA)Phase 4
University of WyomingPhase 2

See all ADDERALL XR 5 clinical trials

Pharmacology for ADDERALL XR 5
Synonyms for ADDERALL XR 5
24 HR Amphetamine aspartate
ADDERALL 10
ADDERALL 12.5
ADDERALL 15
ADDERALL 20
ADDERALL 30
ADDERALL 5
ADDERALL 7.5
ADDERALL XR 10
ADDERALL XR 15
ADDERALL XR 20
ADDERALL XR 25
ADDERALL XR 30
Adzenys XR-ODT
Amphetamine aspartate mixture with amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate
Dextroamphetamine sulfate mixture with dextroamphetamine saccharate and amphetamine aspartate monohydrate and amphetamine sulfate
S900000010

US Patents and Regulatory Information for ADDERALL XR 5

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire ADDERALL XR 5 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-005 May 22, 2002 AB RX Yes No   Start Trial   Start Trial   Start Trial
Shire ADDERALL XR 5 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-005 May 22, 2002 AB RX Yes No   Start Trial   Start Trial   Start Trial
Shire ADDERALL XR 5 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-005 May 22, 2002 AB RX Yes No   Start Trial   Start Trial   Start Trial
Shire ADDERALL XR 5 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-005 May 22, 2002 AB RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ADDERALL XR 5

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Baxter
AstraZeneca
Medtronic
Boehringer Ingelheim

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 verification 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.