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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 amphetamine patent protection?

Amphetamine is the generic ingredient in twenty-five branded drugs marketed by Neos Theraps Inc, Tris Pharma Inc, Neos Theraps, Teva, Shire, Actavis Elizabeth, Impax Labs, Barr Labs Inc, Shire Dev Llc, Teva Womens, Alvogen Malta, Aurolife Pharma Llc, Barr, Epic Pharma Llc, Mylan Pharms Inc, Nesher Pharms, Sandoz, Specgx Llc, Sun Pharm Industries, Sunrise Pharm Inc, Teva Pharms, Ucb Inc, Lannett, and Arbor Pharms Llc, and is included in twenty-eight NDAs. There are nineteen 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-four drug master file entries for amphetamine. Two suppliers are listed for this compound.

Summary for amphetamine

International Patents:	23
US Patents:	19
Tradenames:	25
Applicants:	24
NDAs:	28
Drug Master File Entries:	54
Suppliers / Packagers:	2
Bulk Api Vendors:	29
Clinical Trials:	130
Patent Applications:	6,840
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for amphetamine
DailyMed Link:	amphetamine at DailyMed

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

(+/-)-1-Phenyl-2-aminopropane

(+/-)-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

(Phenylisopropyl)amine

(plusmn)-amphetamine

(S)-.alpha.-Phenylethylamine

(S)-(+)-.beta.-Phenylisopropylamine

[1-(3-Methoxyphenyl)-2-propyl]amine

1-benzylethylamine

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 (tamper and abuse-resistant, Bio-MD/MPAR, ADHD)

Amphetamine (tamper and abuse-resistant, Bio-MD/MPAR, ADHD), PharmacoFore

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, ?-methyl-, (+/-)-

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

CHEBI:132233

CHEBI:2679

CHEMBL405

component of Amodex

component of Biphetamine

d-.alpha.-Methylphenethylamine

d/l-Amphetamine hydrochloride

D/L-AMPHETAMINEHYDROCHLORIDE

D05BMG

D07445

DB00182

DEA No. 1100

Desoxynorephedrin

Desoxynorephedrine

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-Amphetamine-d11 solution

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

Isoamyne

Isomyn

KB-219221

KB-50276

KBio1_000991

KWTSXDURSIMDCE-UHFFFAOYSA-N

L000864

levo-Amphetamine

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

OR038219

OR255017

Oraldrina (Salt/Mix)

Ortedrine

Ortenal (Salt/Mix)

Percomon

PF-08 (Bio-MD/MPAR/prodrug/oral, ADHD), PharmacoFore

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

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)

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	ADDERALL XR 20	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-002	Oct 11, 2001	AB	RX	Yes	No					Y
Shire Dev Llc	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-004	Jun 20, 2017		RX	Yes	No
Actavis Elizabeth	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	206340-005	Feb 5, 2016	AB	RX	No	No
Actavis Elizabeth	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	206340-006	Feb 5, 2016	AB	RX	No	No

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Non-Orange Book US Patents for amphetamine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,839,619	Method for treating ADD or ADHD comprising administering amphetamine complexed with ion-exchange resin particles
9,072,680	Compositions comprising methylphenidate complexed with ion-exchange resin particles
9,675,704	Modified release formulations containing drug-ion exchange resin complexes
9,549,989	Modified release formulations containing drug-ion exchange resin complexes

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International Patents for amphetamine

Country	Document Number	Estimated Expiration
Denmark	2018160
Israel	194042
Australia	2007227569
World Intellectual Property Organization (WIPO)	2013003622