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AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE - Generic Drug Details
What are the generic sources for amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate and what is the scope of freedom to operate?
Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
is the generic ingredient in seventeen branded drugs marketed by Shire, Par Pharm Inc, Actavis Elizabeth, Amerigen Pharms Ltd, Impax Labs, Nesher Pharms, Rhodes Pharms, Specgx Llc, Sun Pharm Industries, Teva, Barr Labs Inc, Shire Dev Llc, Teva Womens, Alvogen, Aurolife Pharma Llc, Barr, Epic Pharma Llc, Mylan, Nuvo Pharm, Sandoz, Sungen Pharma, and Teva Pharms, and is included in twenty-seven NDAs. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate has forty-nine patent family members in thirty countries.
There are fifty-five drug master file entries for amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. Twenty-five suppliers are listed for this compound.
Summary for AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
| International Patents: | 49 |
| US Patents: | 8 |
| Tradenames: | 17 |
| Applicants: | 22 |
| NDAs: | 27 |
| Drug Master File Entries: | 55 |
| Suppliers / Packagers: | 25 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
| DailyMed Link: | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE at DailyMed |
Recent Litigation for AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Shire Development LLC v. SpecGx LLC | 2018-05-25 |
| ADAMAS PHARMA, LLC v. SANDOZ INC. | 2018-05-10 |
| Shire Development LLC v. Impax Laboratories LLC | 2018-04-13 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| KVK-Tech, Inc. | 2017-12-11 |
| Amerigen Pharmaceuticals Limited | 2017-01-13 |
| Mylan Pharmaceuticals Inc. | 2016-10-04 |
