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Phentermine hydrochloride - Generic Drug Details
What are the generic drug sources for phentermine hydrochloride and what is the scope of patent protection?
Phentermine hydrochloride
is the generic ingredient in eleven branded drugs marketed by Teva, Glaxosmithkline, Ferndale Labs, Shire Richwood, Mast Mm, Abc Holding, Able, Aurolife Pharma Llc, Barr, Camall, Chartwell Rx, Duramed Pharms Barr, Elite Labs, Elite Labs Inc, Invagen Pharms, Ivax Pharms, Kvk Tech, Lannett, Lannett Co Inc, Nuvo Pharm, Sandoz, Sun Pharm Industries, Tg United Inc, Upsher Smith Labs, Usl Pharma, Vitarine, Watson Labs, Zydus Pharms, Citius Pharms, Avanthi Inc, Actavis Elizabeth, Kvk Tech Inc, Novast Labs, Polygen Pharms, Prinston Inc, Sandoz Inc, Sun Pharm Inds Inc, Solvay, and Vivus, and is included in one hundred NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Phentermine hydrochloride has two patent family members in two countries.
There are seventeen drug master file entries for phentermine hydrochloride. Thirty-six suppliers are listed for this compound.
Summary for phentermine hydrochloride
International Patents: | 2 |
US Patents: | 11 |
Tradenames: | 11 |
Applicants: | 39 |
NDAs: | 100 |
Drug Master File Entries: | 17 |
Suppliers / Packagers: | 36 |
Bulk Api Vendors: | 36 |
Clinical Trials: | 32 |
Patent Applications: | 1,247 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for phentermine hydrochloride |
DailyMed Link: | phentermine hydrochloride at DailyMed |
Recent Clinical Trials for phentermine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Colorado- Nutrition Obesity Research Center | Phase 2 |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 2 |
Jaime Moore, MD MPH | Phase 2 |
Recent Litigation for phentermine hydrochloride
Identify potential future generic entrants
District Court Litigation
Case Name | Date |
---|---|
ALPEX PHARMA, S.A. v. ZYDUS PHARMACEUTICALS USA, INC. | 2013-07-01 |
See all phentermine hydrochloride litigation
PTAB Litigation
Petitioner | Date |
---|---|
Erich, Spangenberg | 2015-11-24 |
Pharmacology for phentermine hydrochloride
Drug Class | Sympathomimetic Amine Anorectic |
Physiological Effect | Appetite Suppression Increased Sympathetic Activity |
Synonyms for phentermine hydrochloride
.alpha.-Methylamphetamine hydrochloride |
.alpha.,.alpha.-Dimethylphenethylamine hydrochloride |
(1,1-DIMETHYL-2-PHENYL)ETHYLAMINE HYDROCHLORIDE |
0K2I505OTV |
1-Phenyl-2-methyl-2-aminopropane hydrochloride |
1-phenyl-2-methyl-2-aminopropanehydrochloride |
1-Phenyl-2-methyl-2-propylamine Hydrochloride |
1,1-Dimethyl-2-phenylethylamine hydrochloride |
1197-21-3 |
122-09-8 (Parent) |
2-Amino-2-methyl-1-phenylpropane hydrochloride |
2-methyl-1-phenyl-2-propanamine hydrochloride |
2-Methyl-1-phenylpropan-2-amine hydrochloride |
2-methyl-1-phenylpropan-2-amine;hydrochloride |
AC1L2F9M |
Adipex-P |
Adipex-p (TN) |
AKOS015891196 |
alpha-Methylamphetamine hydrochloride |
alpha-methylamphetaminehydrochloride |
alpha,alpha-dimethyl-phenethylaminhydrochloride |
alpha,alpha-Dimethylphenethylamine hydrochloride |
ANW-58508 |
AOB5784 |
API0007710 |
AS01627 |
BCP23776 |
Benzeneethanamine, alpha,alpha-dimethyl-, hydrochloride |
Benzeneethanamine, alpha,alpha-dimethyl, hydrochloride |
Benzeneethanamine,.alpha.-dimethyl, hydrochloride |
benzeneethanamine,alpha,alpha-dimethyl,hydrochloride |
CCG-221139 |
CHEBI:50506 |
CHEMBL1200912 |
CTK6A7128 |
D05459 |
DEA No. 1640 |
DTXSID20152550 |
Duromine Hydrochloride |
EINECS 214-821-9 |
Fastin |
Fastin (TN) |
FT-0673716 |
I01-8880 |
I14-44888 |
Inoamin Hydrochloride |
Ionamin Hydrochloride |
Linyl Hydrochloride |
Lipopill Hydrochloride |
Lomaira |
Lonamin Hydrochloride |
LS-103359 |
MG 18370 |
MG 18570 |
Mirapront Hydrochloride |
MLS003882563 |
NCAIGTHBQTXTLR-UHFFFAOYSA-N |
Normephentermine Hydrochloride |
NSC 44090 |
NSC-44090 |
NSC44090 |
Obestin-30 |
Oby-Trim |
Omnibex Hydrochloride |
Ona Mast |
Ona-Mast |
Ona-Mast hydrochloride |
Phenethylamine, alpha,alpha-dimethyl-, hydrochloride |
Phenteral |
Phenteramine hydrochloride |
Phentermine HCl |
Phentermine hydrochloride (USP) |
Phentermine hydrochloride [USAN] |
Phentermine hydrochloride [USP] |
Phentermine hydrochloride, >=98% (HPLC) |
Phentermine hydrochloride, United States Pharmacopeia (USP) Reference Standard |
Phentermyl Wyncaps |
Phenyl-t-butylamine hydrochloride |
phenyl-t-butylaminehydrochloride |
Phenyl-tert-butylamine Hydrochloride |
S 58 |
SCHEMBL41585 |
SMR000058739 |
Suprenza |
TC-147253 |
TL8000587 |
Tora |
UNII-0K2I505OTV |
Wilpo (VAN) |
Wilpo Hydrochloride |
wilpohydrochloride |
WLN: ZX1&1&1R &GH |
Paragraph IV (Patent) Challenges for PHENTERMINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
SUPRENZA | TABLET, ORALLY DISINTEGRATING;ORAL | phentermine hydrochloride | 202088 | 2013-03-22 |
SUPRENZA | TABLET, ORALLY DISINTEGRATING;ORAL | phentermine hydrochloride | 202088 | 2012-10-19 |
US Patents and Regulatory Information for phentermine hydrochloride
Expired US Patents for phentermine hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Citius Pharms | SUPRENZA | phentermine hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 202088-001 | Jun 13, 2011 | Start Trial | Start Trial |
Citius Pharms | SUPRENZA | phentermine hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 202088-003 | Mar 27, 2012 | Start Trial | Start Trial |
Citius Pharms | SUPRENZA | phentermine hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 202088-002 | Jun 13, 2011 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for phentermine hydrochloride
Country | Patent Number | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 2009098169 | Start Trial |
European Patent Office | 2254558 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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