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Amphetamine - Generic Drug Details

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

Amphetamine is the generic ingredient in twenty-six branded drugs marketed by Neos Theraps Inc, Tris Pharma Inc, Neos Theraps, Teva, Shire, Actavis Elizabeth, Amerigen Pharms Ltd, Impax Labs, Nesher Pharms, Par Pharm Inc, Rhodes Pharms, Specgx Llc, Sun Pharm Industries, Sungen Pharma, Barr Labs Inc, Shire Dev Llc, Teva Womens, Alvogen, Aurolife Pharma Llc, Barr, Epic Pharma Llc, Mylan, Nuvo Pharm, Sandoz, Teva Pharms, Ucb Inc, Arbor Pharms Llc, Amneal Pharms, Bionpharma Inc, Granules Pharms, and Lannett, and is included in forty-one 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. Three suppliers are listed for this compound.

Summary for amphetamine

International Patents:	23
US Patents:	20
Tradenames:	26
Applicants:	31
NDAs:	41
Drug Master File Entries:	55
Suppliers / Packagers:	3
Bulk Api Vendors:	27
Clinical Trials:	149
Patent Applications:	7,176
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for amphetamine
Drug Sales Revenues:	Drug sales revenues for amphetamine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for amphetamine
DailyMed Link:	amphetamine at DailyMed

See drug prices for amphetamine

See drug sales revenues for amphetamine

Recent Clinical Trials for amphetamine

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

Sponsor	Phase
Weill Medical College of Cornell University	Early Phase 1
Lindner Center of HOPE	Phase 2
Mayo Clinic	Phase 2

See all amphetamine clinical trials

Recent Litigation for amphetamine

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for amphetamine

Adrenergic Agents

Adrenergic Uptake Inhibitors

Central Nervous System Stimulants

Dopamine Agents

Dopamine Uptake Inhibitors

Sympathomimetics

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
Shire Dev Llc	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-003	Jun 20, 2017		RX	Yes	No
Shire Dev Llc	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-004	Jun 20, 2017		RX	Yes	Yes			Y
Teva Pharms	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	040472-003	Sep 30, 2003		DISCN	No	No
Nesher Pharms	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	210080-001	Jul 17, 2019	AB	RX	No	No

International Patents for amphetamine

Country	Patent Number	Estimated Expiration
European Patent Office	2018160
Japan	2009530298
European Patent Office	2726066
South Korea	20080108520