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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Fuji
McKinsey
AstraZeneca
Farmers Insurance
Accenture
Julphar
Federal Trade Commission
US Army

Generated: August 19, 2018

DrugPatentWatch Database Preview

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.

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
(+/-)-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
Alvogen Malta DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 207388-001 Jul 28, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurolife Pharma Llc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 202424-002 Nov 27, 2013 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Specgx Llc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040440-007 Oct 7, 2003 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sun Pharm Industries DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040480-004 Sep 9, 2003 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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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
9,072,680 Compositions comprising methylphenidate complexed with ion-exchange resin particles ➤ Try a Free Trial
9,089,496 Compositions comprising methylphenidate complexed with ion-exchange resin particles ➤ Try a Free Trial
9,839,619 Method for treating ADD or ADHD comprising administering amphetamine complexed with ion-exchange resin particles ➤ Try a Free Trial
8,202,537 Modified release formulations containing drug-ion exchange resin complexes ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Teva
Dow
AstraZeneca
Mallinckrodt
UBS
Harvard Business School
Argus Health
US Department of Justice

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 verifification 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.