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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 |
