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

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Last Updated: December 11, 2019

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Midodrine hydrochloride - Generic Drug Details

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

Midodrine hydrochloride is the generic ingredient in three branded drugs marketed by Apotex Inc, Casi Pharms Inc, Impax Pharms, Mylan Pharms Inc, Par Pharm Inc, Rubicon, Unique Pharm Labs, Upsher Smith Labs, and Shire Llc, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for midodrine hydrochloride. Sixteen suppliers are listed for this compound.

Recent Clinical Trials for midodrine hydrochloride

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

SponsorPhase
University of California, Los AngelesEarly Phase 1
H.A.C. PHARMAPhase 4
National Liver Institute, EgyptN/A

See all midodrine hydrochloride clinical trials

Pharmacology for midodrine hydrochloride
Medical Subject Heading (MeSH) Categories for midodrine hydrochloride
Synonyms for midodrine hydrochloride
( -)-Midodrin hydrochloride
( -)-Midodrine hydrochloride
(+-)-1-(2',5'-Dimethoxyphenyl)-2-glycinamidoethanol hydrochloride
(+-)-2-Amino-N-(beta-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride
(+-)-Midodrin hydrochloride
(+-)-Midodrine hydrochloride
[+/-]-1-[2,5-Dimethoxyphenyl]-2-glycinamidoethanol
092M179
1-(2',5'-Dimethoxyphenyl)-2-glycinamidoethanol hydrochloride
2- degrees +/->>u-N-[2-(2,5- paragraph signthorn(1/4)xNo>>u+/-(1/2)>>u)-2-oCOO>>u]OOo pound degrees .
2-amino-N-(2-(2,5-dimethoxyphenyl)-2-hydroxyethyl)acetamide hydrochloride
2-Amino-N-(2-(2,5-dimethoxyphenyl)-2-hydroxyethyl)acetamide monohydrochloride
2-Amino-N-(2-(2,5-dimethoxyphenyl)-2-hyyroxyethyl)acetamide monohydrochloride
2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-acetamide hydrochloride
2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]acetamide hydrochloride
2-Amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]acetamide monohydrochloride
2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]acetamide, chloride
2-azanyl-N-[2-(2,5-dimethoxyphenyl)-2-oxidanyl-ethyl]ethanamide hydrochloride
218M560
3092-17-9
43218-56-0
A 4020 Linz
A-4020 Linz
A820652
AC1L2BU9
Acetamide, 2-amino-N-(2-(2,5-dimethoxyphenyl)-2-hydroxyethyl)-, monohydrochloride
Acetamide, 2-amino-N-(2-(2,5-dimethoxyphenyl)-2-hydroxyethyl)-, monohydrochloride, (+-)-
Acetamide, 2-amino-N-(beta-hydroxy-2,5-dimethoxyphenethyl)-, hydrochloride
Acetamide, 2-amino-N-(beta-hydroxy-2,5-dimethoxyphenethyl)-, monohydrochloride, (+-)-
ACM43218560
AKOS015895724
Alphamine
Amatine
API0001437
API0024416
C12H18N2O4.HCl
C12H19ClN2O4
CAS-3092-17-9
CCG-39323
CHEBI:31847
CHEMBL1200461
CPD000058833
CS-4689
CTK1D6108
D01307
DSSTox_CID_27493
DSSTox_GSID_47493
DSSTox_RID_82380
DTXSID1047493
EINECS 256-148-3
FT-0603627
FT-0701302
Gutron
Hipertan
HMS1568H03
HMS1922O03
HS-0099
HY-12749A
I06-0865
LS-8042
LS-8052
MCULE-8615039451
Metligene
MGCQZNBCJBRZDT-UHFFFAOYSA-N
Midamine
Midodrine (hydrochloride)
Midodrine HCL
Midodrine hydrochloride (JAN/USAN)
Midodrine hydrochloride [USAN:JAN]
Midodrine hydrochloride [USAN:USP:JAN]
Midodrine hydrochloride [USAN]
Midodrine hydrochloride, analytical standard, for drug analysis
Midodrine hydrochloride, United States Pharmacopeia (USP) Reference Standard
Midodrine Monohydrochloride
MLS001332567
MLS001332568
MLS002154233
MolPort-003-666-473
NC00573
NCGC00016620-01
NCGC00095311-01
NCGC00178238-05
NCGC00256810-01
NSC-758429
NSC758429
Pharmakon1600-01503257
Prestwick_625
Pro-Amatine
Pro-Amatine (TN)
ProAmatine
Q-201404
rac-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]glycinamide hydrochloride
s120
SAM002564219
SCHEMBL41463
SMR000058833
SPECTRUM1503257
SR-05000001847-3
St 1085
St 1085 [as the base]
ST-1085 [As The Base]
St. Peter 224
ST51037351
TL8002369
Tox21_110529
Tox21_110529_1
Tox21_302723
TS 701
VA11298

US Patents and Regulatory Information for midodrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Unique Pharm Labs MIDODRINE HYDROCHLORIDE midodrine hydrochloride TABLET;ORAL 207613-002 Nov 2, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Rubicon MIDODRINE HYDROCHLORIDE midodrine hydrochloride TABLET;ORAL 212543-002 Aug 19, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Shire Llc PROAMATINE midodrine hydrochloride TABLET;ORAL 019815-002 Sep 6, 1996 DISCN Yes 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

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Colorcon
Merck

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