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adderall 30 Drug Profile
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When do Adderall 30 patents expire, and what generic alternatives are available?
Adderall 30 is a drug marketed by Teva Womens and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has six patent family members in six countries.
The generic ingredient in ADDERALL 30 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 30
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for adderall 30
| International Patents: | 6 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 38 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | adderall 30 at DailyMed |
Recent Clinical Trials for adderall 30
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 30
US Patents and Regulatory Information for adderall 30
| 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 30 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | TABLET;ORAL | 011522-010 | 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 30
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva Womens | ADDERALL 30 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | TABLET;ORAL | 011522-010 | May 12, 1997 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for adderall 30
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2378336 | Start Trial |
| Mexico | PA02000290 | Start Trial |
| Japan | 2003504406 | Start Trial |
| Australia | 6089200 | Start Trial |
| European Patent Office | 1202739 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
