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ADDERALL 5 Drug Profile
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Which patents cover Adderall 5, and when can generic versions of Adderall 5 launch?
Adderall 5 is a drug marketed by Teva Womens and is included in one NDA. There is one patent protecting this drug.
This drug has six patent family members in six countries.
The generic ingredient in ADDERALL 5 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 5
Indicators of Generic Entry
Summary for ADDERALL 5
International Patents: | 6 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Bulk Api Vendors: | 1 |
Clinical Trials: | 38 |
Formulation / Manufacturing: | see details |
DailyMed Link: | ADDERALL 5 at DailyMed |

Recent Clinical Trials for ADDERALL 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 5
US Patents and Regulatory Information for ADDERALL 5
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Womens | ADDERALL 5 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | TABLET;ORAL | 011522-009 | May 12, 1997 | DISCN | Yes | No | Start Trial | Start Trial | Y | 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 5
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Teva Womens | ADDERALL 5 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | TABLET;ORAL | 011522-009 | May 12, 1997 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ADDERALL 5
Country | Patent Number | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 0105407 | Start Trial |
European Patent Office | 1202739 | Start Trial |
Australia | 6089200 | Start Trial |
Japan | 2003504406 | Start Trial |
Mexico | PA02000290 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |