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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
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 |
Recent Clinical Trials for ADDERALL XR 25
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute on Drug Abuse (NIDA) | Phase 4 |
| Jeffrey Newcorn | Phase 4 |
| University of Wyoming | Phase 2 |
Pharmacology for ADDERALL XR 25
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
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 |
Paragraph IV (Patent) Challenges for ADDERALL XR 25
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ADDERALL XR 5 | CAPSULE, EXTENDED RELEASE;ORAL | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | 021303 | |
| 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 |
US Patents and Regulatory Information for ADDERALL XR 25
Expired US Patents for ADDERALL XR 25
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Shire | ADDERALL XR 25 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303-004 | May 22, 2002 | 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 | 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 | 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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ADDERALL XR 25
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2323910 | Start Trial |
| Germany | 69940673 | Start Trial |
| Canada | 2348090 | Start Trial |
| European Patent Office | 1977736 | Start Trial |
| Austria | 427101 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0023055 | Start Trial |
| Japan | 2002527468 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
