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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 Takeda Pharms Usa and is included in one NDA.
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. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.
Summary for ADDERALL XR 5
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Bulk Api Vendors: | 1 |
Clinical Trials: | 38 |
Formulation / Manufacturing: | see details |
DailyMed Link: | ADDERALL XR 5 at DailyMed |

Recent Clinical Trials for ADDERALL XR 5
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of California, Los Angeles | Early Phase 1 |
National Institute on Drug Abuse (NIDA) | Phase 4 |
Jeffrey Newcorn | Phase 4 |
Paragraph IV (Patent) Challenges for ADDERALL XR 5
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
ADDERALL XR 20 | CAPSULE, EXTENDED RELEASE;ORAL | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | 021303 | |
ADDERALL XR 25 | CAPSULE, EXTENDED RELEASE;ORAL | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | 021303 | |
ADDERALL XR 10 | CAPSULE, EXTENDED RELEASE;ORAL | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | 021303 | |
ADDERALL XR 30 | CAPSULE, EXTENDED RELEASE;ORAL | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | 021303 | |
ADDERALL XR 15 | CAPSULE, EXTENDED RELEASE;ORAL | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | 021303 | |
ADDERALL XR 5 | CAPSULE, EXTENDED RELEASE;ORAL | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | 021303 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | 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
International Patents for ADDERALL XR 5
Country | Patent Number | Estimated Expiration |
---|---|---|
European Patent Office | 1977736 | Start Trial |
Canada | 2348090 | Start Trial |
Japan | 2002527468 | Start Trial |
Germany | 69940673 | Start Trial |
Australia | 1214500 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |