Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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McKesson
Baxter

Last Updated: December 11, 2019

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Amphetamine - Generic Drug Details

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What are the generic sources for amphetamine and what is the scope of patent protection?

Amphetamine is the generic ingredient in twenty-seven branded drugs marketed by Neos Theraps Inc, Tris Pharma Inc, Neos Theraps, Teva, Shire, Par Pharm Inc, Actavis Elizabeth, Amerigen Pharms Ltd, Impax Labs, Nesher Pharms, Rhodes Pharms, Specgx Llc, Sun Pharm Industries, Barr Labs Inc, Shire Dev Llc, Teva Womens, Alvogen, Aurolife Pharma Llc, Barr, Epic Pharma Llc, Mylan, Nuvo Pharm, Sandoz, Sungen Pharma, Teva Pharms, Ucb Inc, Arbor Pharms Llc, Amneal Pharms, Granules Pharms, and Lannett, and is included in thirty-nine NDAs. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amphetamine has twenty-three patent family members in fourteen countries.

There are fifty-five drug master file entries for amphetamine. Two suppliers are listed for this compound.

Drug Prices for amphetamine

See drug prices for amphetamine

Drug Sales Revenue Trends for amphetamine

See drug sales revenues for amphetamine

Recent Clinical Trials for amphetamine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Massachusetts Institute of TechnologyPhase 2
Tris Pharma, Inc.Phase 2
Noven TherapeuticsPhase 1

See all amphetamine clinical trials

Recent Litigation for amphetamine

Identify potential future generic entrants

District Court Litigation
Case NameDate
Neos Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc.2017-12-13
Tris Pharma Inc. v. Par Pharmaceutical Inc.2015-01-21
Tris Pharma Inc. v. Actavis Laboratories FL Inc.2014-10-15

See all amphetamine litigation

Pharmacology for amphetamine
Synonyms for amphetamine
.alpha.-Methylbenzeneethanamine
.alpha.-Methylbenzeneethaneamine
.alpha.-Methylphenethylamine
.alpha.-Methylphenethylamine, d-form
.alpha.-Methylphenylethylamine
.beta.-Aminopropylbenzene
.beta.-Phenylisopropylamin
.beta.-Phenylisopropylamine
(.+/-.)-.alpha.-Methylphenethylamine
(.+/-.)-.alpha.-Methylphenylethylamine
(.+/-.)-.beta.-Phenylisopropylamine
(.+/-.)-Benzedrine
(.+/-.)-Desoxynorephedrine
(+-)-alpha-Methylbenzeneethanamine
(+-)-alpha-Methylphenethylamine
(+-)-alpha-Methylphenylethylamine
(+-)-Benzedrine
(+)-.alpha.-Methylphenethylamine
(+)-.alpha.-Methylphenylethylamine
(+/-)-Amphetamine solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
(+/-)-Amphetamine solution, 100 mug/mL in methanol, ampule of 1 mL, certified reference material
(+/-)-Benzedrine
(+/-)-beta-Phenylisopropylamine
(+/-)-Desoxynorephedrine
(Phenylisopropyl)amine
(plusmn)-amphetamine
(S)-.alpha.-Phenylethylamine
(S)-(+)-.beta.-Phenylisopropylamine
[1-(3-Methoxyphenyl)-2-propyl]amine
1-Methyl-2-phenylethylamine
1-Phenyl-2-amino-propan
1-Phenyl-2-amino-propan [German]
1-Phenyl-2-aminopropane
1-Phenyl-2-aminopropane (VAN)
1-Phenyl-2-propanamine
1-Phenyl-2-propylamine
1-phenylpropan-2-amine
17108-96-2
2-Amino-1-phenylpropane
3-Phenyl-2-propylamine
3-phenylpropan-2-amine
300-62-9
3797-EP2275420A1
3797-EP2295439A1
3797-EP2298734A2
3797-EP2298742A1
3797-EP2298779A1
3797-EP2305219A1
3797-EP2305648A1
3797-EP2305656A1
3797-EP2308867A2
3797-EP2308870A2
3797-EP2311801A1
3797-EP2311802A1
3797-EP2311803A1
3797-EP2314571A2
3797-EP2371814A1
60-13-9 (sulfate (2:1))
60-15-1
96332-84-2
AC1L1EYQ
AC1Q5065
Actedron
Adderal
Adderall
Adderall XR
Adipan
Adzenys ER
AI3-02438
AKOS022196414
Allodene
alpha-methyl phenethylamine
ALPHA-METHYL-BENZENEETHANAMIDE (SEE ALSO DL-AMPHETAMINE SULFATE)
alpha-Methylbenzeneethanamine
alpha-Methylbenzeneethaneamine
alpha-Methylphenethylamine
alpha-Methylphenylethylamine
Amfetamin (TN)
Amfetamina [INN-Spanish]
Amfetamina [Italian]
Amfetamine
Amfetamine (INN)
Amfetamine [INN:BAN]
amfetaminum
Amfetaminum [INN-Latin]
Amphetamin
AMPHETAMINE (SEE ALSO: D-AMPHETAMINE (51-64-9) & AMPHETAMINE SULFATE (60-13-9))
Amphetamine mixture with Dextroamphetamine
Amphetamine resin complex
Amphetamine salts
Amphetamine Sulfate (2:1)
AMPHETAMINE, (D)
Amphetamine, its salts, optical isomers, and salts of its optical isomers
AN-23365
Anfetamina [Spanish]
Anorexide
Anorexine
BDBM50005246
Benzebar
Benzedrine
Benzeneethanamine, .alpha.-methyl-
Benzeneethanamine, .alpha.-methyl-, (.+/-.)-
Benzeneethanamine, .alpha.-methyl-, (.alpha.S)-
Benzeneethanamine, .alpha.-methyl-, (S)-
Benzeneethanamine, (S)-
Benzeneethanamine, alpha-methyl-
Benzeneethanamine, alpha-methyl-, (+-)-
Benzolone
beta-Aminopropylbenzene
beta-Aminopropylbenzene (VAN)
beta-phenyl-isopropylamine
beta-Phenylisopropylamin
beta-Phenylisopropylamin [German]
beta-Phenylisopropylamine
C07514
C9H13N
CHEBI:132233
CHEBI:2679
CHEMBL405
component of Amodex
component of Biphetamine
d-.alpha.-Methylphenethylamine
D07445
DB00182
DEA No. 1100
DELCOBESE
Desoxynorephedrin
Desoxynorephedrine
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
DivK1c_000991
DL-.alpha.-Methylphenethylamine
dl-1-Phenyl-2-aminopropane
dl-alpha-Methylphenethylamine
dl-Amphetamine
DL-Amphetamine solution
DL-Amphetamine solution, 1 mg/mL in methanol, drug standard
dl-Benzedrine
DTXSID4022600
Dyanavel XR
EINECS 200-458-3
EINECS 206-096-2
Elastonon
Euphodyn (Salt/Mix)
Fabedrine (Salt/Mix)
Fenamin (Salt/Mix)
Fenopromin
Fenylo-izopropylaminyl
Fenylo-izopropylaminyl [Polish]
Finam
FT-0631912
FT-0694835
GTPL4804
HMS503G03
HSDB 3287
IDI1_000991
Isoamycin
Isoamyne
Isomyn
KB-219221
KB-50276
KBio1_000991
KWTSXDURSIMDCE-UHFFFAOYSA-N
L000864
levo-Amphetamine
Levoamphetamine
LS-1148
LS-1428
MCULE-4193952437
Mecodrin
Mydrial
NINDS_000991
Noclon (Salt/Mix)
Norephedrane
Norephedrine, deoxy-
Novydrine
NSC 27159
NSC-27159
NSC-73713
NSC27159
NSC73713
NT-0201
Oktedrin
Oprea1_447423
Oraldrina (Salt/Mix)
Ortedrine
Ortenal (Salt/Mix)
Percomon
Phenamine
Phenedrine
Phenethylamine, .alpha.-methyl-
Phenethylamine, .alpha.-methyl-, (.+/-.)-
Phenethylamine, (+)-
Phenethylamine, alpha-methyl-
Phenethylamine, alpha-methyl-, (+-)-
Phenethylamine, alpha-methyl, (+-)-
Phenethylamine, d-
Phenethylamine, D-.alpha.-methyl-
Profamina
Propisamine
Protioamphetamine
Psychedrine
rac-(2R)-1-phenylpropan-2-amine
rac-Amphetamine
rac-Amphetamine 1.0 mg/ml in Methanol
racemic-Desoxynor-ephedrine
Raphetamine
Rhinalator
S(+)-Amphetamine
SCHEMBL8858
Simpatedrin
Simpatina
Stimulan (Salt/Mix)
Sympametin (Salt/Mix)
Sympamine
Sympatedrine
Thyramine
Vapedrine (Salt/Mix)
Weckamine
WLN: ZY1&1R
WLN: ZY1&1R -D
Zedrine (Salt/Mix)
Paragraph IV (Patent) Challenges for AMPHETAMINE
Tradename Dosage Ingredient NDA Submissiondate
ADZENYS XR-ODT TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL amphetamine 204326 2016-05-10

US Patents and Regulatory Information for amphetamine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Industries DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040480-007 Sep 9, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
Aurolife Pharma Llc AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 211639-001 Apr 17, 2019 AA RX No No   Start Trial   Start Trial   Start Trial
Neos Theraps ADZENYS XR-ODT amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 204326-003 Jan 27, 2016 RX 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

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Harvard Business School
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Merck

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