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Last Updated: February 27, 2021

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AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE - Generic Drug Details

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What are the generic drug 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 sixteen branded drugs marketed by Takeda Pharms Usa, Actavis Elizabeth, Ani Pharms Inc, Elite Labs Inc, Impax Labs, Mylan, Nesher Pharms, Par Pharm Inc, Rhodes Pharms, Specgx Llc, Sun Pharm Industries, Teva, Barr Labs Inc, Teva Womens, Alvogen, Aurolife Pharma Llc, Barr, Epic Pharma Llc, Nuvo Pharm, Sandoz, Teva Pharms, and Uspharma, and is included in thirty NDAs. There are four 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 thirty-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-six suppliers are listed for this compound.

Pharmacology for AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Paragraph IV (Patent) Challenges for AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Tradename Dosage Ingredient NDA Submissiondate
MYDAYIS CAPSULE, EXTENDED RELEASE;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 022063 2017-08-07
MYDAYIS CAPSULE, EXTENDED RELEASE;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 022063 2017-08-03
ADDERALL 7.5 TABLET;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 011522 2009-11-18
ADDERALL 20 TABLET;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 011522 2009-11-18
ADDERALL 10 TABLET;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 011522 2009-11-18
ADDERALL 30 TABLET;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 011522 2009-11-18
ADDERALL 12.5 TABLET;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 011522 2009-11-18
ADDERALL 5 TABLET;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 011522 2009-11-18
ADDERALL 15 TABLET;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 011522 2009-11-18
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 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Epic Pharma Llc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040444-001 Jun 19, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Epic Pharma Llc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040444-006 Nov 3, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-001 Jun 20, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Sandoz DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040439-001 Jun 14, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Nuvo Pharm DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 209799-002 Dec 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Aurolife Pharma Llc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 202424-001 Nov 27, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Nesher Pharms DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 210080-005 Jul 17, 2019 DISCN No 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 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Womens ADDERALL 7.5 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 011522-011 Aug 31, 2000   Start Trial   Start Trial
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-001 Jun 20, 2017   Start Trial   Start Trial
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-004 Jun 20, 2017   Start Trial   Start Trial
Teva Womens ADDERALL 15 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 011522-013 Aug 31, 2000   Start Trial   Start Trial
Takeda Pharms Usa ADDERALL XR 25 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-004 May 22, 2002   Start Trial   Start Trial
Takeda Pharms Usa ADDERALL XR 30 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-003 Oct 11, 2001   Start Trial   Start Trial
Takeda Pharms Usa 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 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Country Patent Number Estimated Expiration
Poland 375991   Start Trial
Canada 2499546   Start Trial
Eurasian Patent Organization 018082   Start Trial
Norway 336938   Start Trial
European Patent Office 1542660   Start Trial
Iceland 7818   Start Trial
Slovenia 1542660   Start Trial
>Country >Patent Number >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.