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Last Updated: January 22, 2020

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ADDERALL XR 25 Drug Profile

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When do Adderall Xr 25 patents expire, and what generic alternatives are available?

Adderall Xr 25 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 25 is amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Twenty-five 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 25

Adderall Xr 25 was eligible for patent challenges on December 31, 1968.

Indicators of Generic Entry

Low

  Start Trial

Summary for ADDERALL XR 25
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 25 at DailyMed
Drug patent expirations by year for ADDERALL XR 25
Recent Clinical Trials for ADDERALL XR 25

Identify potential brand extensions & 505(b)(2) entrants

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

See all ADDERALL XR 25 clinical trials

Pharmacology for ADDERALL XR 25
Synonyms for ADDERALL XR 25
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 30
ADDERALL XR 5
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 25

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 25 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-004 May 22, 2002 AB RX Yes No   Start Trial   Start Trial   Start Trial
Shire ADDERALL XR 25 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-004 May 22, 2002 AB RX Yes No   Start Trial   Start Trial   Start Trial
Shire ADDERALL XR 25 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-004 May 22, 2002 AB RX Yes No   Start Trial   Start Trial   Start Trial
Shire ADDERALL XR 25 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-004 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 25

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