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ADDERALL XR 10 Drug Profile
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» See Plans and PricingWhen do Adderall Xr 10 patents expire, and what generic alternatives are available?
Adderall Xr 10 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 10 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 10
There have been twelve patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for ADDERALL XR 10
| International Patents: | 10 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 36 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ADDERALL XR 10 |
| DailyMed Link: | ADDERALL XR 10 at DailyMed |
Recent Clinical Trials for ADDERALL XR 10
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Jeffrey Newcorn | Phase 4 |
| National Institute on Drug Abuse (NIDA) | Phase 4 |
| University of Wyoming | Phase 2 |
Recent Litigation for ADDERALL XR 10
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Shire Development LLC v. Rhodes Pharmaceuticals L.P. | 2017-12-21 |
| Shire Development LLC v. Teva Pharmaceuticals USA, Inc. | 2017-11-22 |
| Shire LLC v. Abhai LLC | 2015-11-20 |
See all ADDERALL XR 10 litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Pharmaceuticals Inc. | 2016-10-04 |
| Mylan Pharmaceuticals Inc. | 2016-05-12 |
| Amerigen Pharmaceuticals Limited | 2015-10-01 |
Pharmacology for ADDERALL XR 10
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Synonyms for ADDERALL XR 10
| 24 HR Amphetamine aspartate |
| ADDERALL 10 |
| ADDERALL 12.5 |
| ADDERALL 15 |
| ADDERALL 20 |
| ADDERALL 30 |
| ADDERALL 5 |
| ADDERALL 7.5 |
| ADDERALL XR 15 |
| ADDERALL XR 20 |
| ADDERALL XR 25 |
| 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 10
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| 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 | |
| ADDERALL XR 20 | CAPSULE, EXTENDED RELEASE;ORAL | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | 021303 |
US Patents and Regulatory Information for ADDERALL XR 10
| 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 10 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303-001 | Oct 11, 2001 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Shire | ADDERALL XR 10 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303-001 | Oct 11, 2001 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Shire | ADDERALL XR 10 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303-001 | Oct 11, 2001 | 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 10
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Shire | ADDERALL XR 10 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303-001 | Oct 11, 2001 | Start Trial | Start Trial |
| Shire | ADDERALL XR 10 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303-001 | Oct 11, 2001 | Start Trial | Start Trial |
| Shire | ADDERALL XR 10 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE;ORAL | 021303-001 | Oct 11, 2001 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ADDERALL XR 10
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Austria | 427101 | Start Trial |
| Germany | 69940673 | Start Trial |
| European Patent Office | 1123087 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
