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Last Updated: December 9, 2019

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Tolterodine tartrate - Generic Drug Details

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What are the generic drug sources for tolterodine tartrate and what is the scope of freedom to operate?

Tolterodine tartrate is the generic ingredient in three branded drugs marketed by Pharmacia And Upjohn, Hetero Labs Ltd Iii, Inventia Hlthcare, Mylan, Teva Pharms Usa, Torrent, Apotex Corp, Ivax Sub Teva Pharms, Macleods Pharms Ltd, and Mylan Pharms Inc, and is included in eleven NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tolterodine tartrate has one hundred and thirty-seven patent family members in forty-four countries.

There are twenty-three drug master file entries for tolterodine tartrate. Eighteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for tolterodine tartrate

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Drug Sales Revenue Trends for tolterodine tartrate

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Recent Clinical Trials for tolterodine tartrate

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

SponsorPhase
Shanghai Institute of Acupuncture, Moxibustion and MeridianN/A
RenJi HospitalN/A
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all tolterodine tartrate clinical trials

Recent Litigation for tolterodine tartrate

Identify potential future generic entrants

District Court Litigation
Case NameDate
PFIZER INC. v. LUPIN LTD.2013-03-21
PFIZER INC. v. TEVA PHARMACEUTICALS USA, INC.2008-03-13
Pfizer Inc. v. IMPAX Laboratories, Inc.2008-03-04

See all tolterodine tartrate litigation

Generic filers with tentative approvals for TOLTERODINE TARTRATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial2MGTABLET; ORAL
  Start Trial  Start Trial1MGTABLET; ORAL
  Start Trial  Start Trial2MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for tolterodine tartrate
Medical Subject Heading (MeSH) Categories for tolterodine tartrate
Synonyms for tolterodine tartrate
(+)-(r)-2-(a-[2-(diisopropylamino)ethyl]benzyl)-p-cresol tartrate
(+)-(R)-2-(alpha-(2-(Diisopropylamino)ethyl)benzyl)-p-cresol
(+)-(R)-2-(I-(2-(Diisopropylamino)ethyl)benzyl)-p-cresol L-tartrate (1:1) (salt)
(+)-(R)-3-(2-hydroxy-5-methylphenyl)-N,N-diisopropyl-3-phenylpropylamine
(+)-r)-2-{a-(2-(diisopropylamino)ethyl)benzyl}-p-cresol tartrate
(+)-Tolterodine
(2R,3R)-2,3-dihydroxybutanedioic acid,2-[(1R)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-methylphenol
(2R,3R)-2,3-dihydroxybutanedioic acid; 2-[(1R)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-methylphenol
(2R,3R)-2,3-dihydroxybutanedioic acid;2-[(1R)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-methylphenol
(R)-(+)-N,N-Diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropylamine
(R)-(+)-Tolterodine
(R)-2-(3-(Bis(1-methylethyl)amino)-1-phenylpropyl)-4-methylphenol (R-(R*,R*))-2,3-dihydroxybutanedioate (1:1) (salt)
(R)-2-(3-(diisopropylamino)-1-phenylpropyl)-
(r)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-methylphenol
(R)-2-(3-(Diisopropylamino)-1-phenylpropyl)-4-methylphenol (2R,3R)-2,3-dihydroxysuccinate
(R)-2-(3-(Diisopropylamino)-1-phenylpropyl)-4-methylphenol 2,3-dihydroxysuccinate
(R)-2-(3-Diisopropylamino-1-phenyl-propyl)-p-cresol L-tartrate
(R)-2-[3-(diisopropylamino)-1-phenylpropyl]-4-methylphenol
(R)-2-[3-(Diisopropylamino)-1-phenylpropyl]-4-methylphenol L-Tartrate
(R)-2-[3-(Diisopropylamino)-1-phenylpropyl]-4-methylphenolL-Tartrate
(R)-2,3-BIS(1-METHYLETHYL)AMINO-1-PHENYLPROPYL-4-METHYLPHENOL
(R)-Tolterodine
(tolterodine tartrate)
124937-51-5
124937-52-6
124937-53-7
2-[(1R)-3-(di(propan-2-yl)amino)-1-phenylpropyl]-4-methylphenol
2-[(1R)-3-(diisopropylamino)-1-phenylpropyl]-4-methylphenol
2-[(1R)-3-[BIS(1-METHYLETHYL)AMINO]-1-PHENYLPROPYL]-4-METHYL-PHENOL TARTRATE
2-[(1R)-3-[Bis(1-methylethyl)amino]-1-phenylpropyl]-4-methylphenol
2-[(1R)-3-[Bis(1-methylethyl)amino]-1-phenylpropyl]-4-methylphenol (2R,3R)-2,3-dihydroxybutanedioate
2-[(1R)-3-[bis(propan-2-yl)amino]-1-phenylpropyl]-4-methylphenol
2-[(1R)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-methylphenol
2-[3-[Bis(1-Methylethyl)Amino]-1-Phenylpropyl]-4-Methyl Phenol Monohydrobromide
2-{(1R)-3-[bis(1-methylethyl)amino]-1-phenylpropyl}-4-methylphenol
209747-05-7
215929-30-9
27817-EP2269989A1
27817-EP2298767A1
27817-EP2314587A1
4-methylphenol (2R,3R)-2,3-dihydroxysuccinate
5T619TQR3R
937T515
937T526
AB00698547_13
AB00698547-12
AB14347
AB2000647
AB42195
AC-2617
AC-3472
AC1L9FDO
AC1L9FDR
ACM209747057
ACT03352
ACT04387
AJ-24600
AK-72840
AKOS015841711
AKOS015895578
AKOS015920262
AKOS015961803
ANW-44905
API0004447
API0008372
AS-35344
AX8017869
BCP0726000292
BDBM50165008
BIDD:GT0318
BR-72840
C07750
C22H31NO.C4H6O6
C26H37NO7
CAS-124937-51-5
CCG-100865
CCG-221263
CHEBI:9622
CHEMBL1382
CHEMBL1722209
CPD000469196
CS-0441
CS-1799
CTK8B4394
D00646
D01148
DB01036
Detrol
Detrol (TN)
Detrol LA
Detrol LA;Kabi-2234;PNU-200583E
Detrusitol
Detrusitol (TN)
Detrusitol SR
DS-1398
DSSTox_CID_3687
DSSTox_GSID_23687
DSSTox_RID_77147
DTXSID3023687
FT-0082150
FT-0082998
FT-0085110
FT-0602571
FT-0631119
FT-0675276
GTPL360
HMS2051E12
HMS2230E24
HMS2230P06
HMS3715N08
HY-90010
HY-A0024
J-005184
J-500064
Jsp001637
Jsp001638
Kabi 2234
Kabi-2234
KS-0000099P
KS-5165
L-tartaric acid; tolterodine
LS-172609
LS-187278
MFCD07771985
MLS001195620
MLS001304745
MLS001401389
MLS003915640
MLS006010051
MolPort-002-885-868
MolPort-003-850-574
MolPort-005-935-051
NC00115
NCGC00159519-02
NCGC00263557-01
OOGJQPCLVADCPB-HXUWFJFHSA-N
PHA-686464B
Phenol, 2-((1R)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-methyl-
Phenol, 2-((1R)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-methyl-, (2R,3R)-2,3-dihydroxybutanedioate (1:1) (salt)
Phenol, 2-(3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-methyl-, (R)-, (R-(R*,R*))-2,3-dihydroxybutanedioate (1:1) (salt)
Phenol,2-((1R)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-methyl-,(2R,3R)-2,3-dihydroxybutanedioate
PNU 200583
PNU 200583E
PNU-200583E
PubChem20792
Q-200223
RL01153
RT-015598
RTR-003803
S-(-)-Tolterodine
s-tolterodine
s2550
SAM001246691
SC-18999
SCHEMBL3064
SCHEMBL36881
SCHEMBL467372
SMR000469196
SMR000596518
SMR002544692
ST2402599
SW197495-2
tolterodin
TOLTERODIN HYDROGEN TARTRATE
Tolterodina
tolterodine
Tolterodine (USAN/INN)
Tolterodine [USAN:INN:BAN]
tolterodine extended release capsules
Tolterodine L-Tartrate
tolterodine l-tartrate 124937-51-5
Tolterodine L-tartrate, >=98% (HPLC)
Tolterodine tartrate (Detrol LA)
Tolterodine tartrate (JAN/USAN)
Tolterodine tartrate [USAN]
Tolterodine Tartrate,(S)
Tolterodine Tartrate|124937-52-6|Kabi-2234|PNU-200583E
tolterodine, tartrate
Tolterodinetartrate
Tolterodinum
Tolterondine Tartrate
Tox21_111737
Tox21_111737_1
TWHNMSJGYKMTRB-KXYUELECSA-N
TWHNMSJGYKMTRB-VEIFNGETSA-N
Unidet
UNII-5T619TQR3R
UNII-WHE7A56U7K
Urotrol
WHE7A56U7K
ZINC968336
Paragraph IV (Patent) Challenges for TOLTERODINE TARTRATE
Tradename Dosage Ingredient NDA Submissiondate
DETROL LA CAPSULE, EXTENDED RELEASE;ORAL tolterodine tartrate 021228 2007-07-30
DETROL TABLET;ORAL tolterodine tartrate 020771

US Patents and Regulatory Information for tolterodine tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd Iii TOLTERODINE TARTRATE tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 206419-002 Dec 12, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Inventia Hlthcare TOLTERODINE TARTRATE tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 204562-002 Aug 19, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 077006-001 Feb 23, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Pharmacia And Upjohn DETROL LA tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 021228-002 Dec 22, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pharmacia And Upjohn DETROL LA tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 021228-001 Dec 22, 2000 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Pharmacia And Upjohn DETROL LA tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 021228-002 Dec 22, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for tolterodine tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn DETROL tolterodine tartrate TABLET;ORAL 020771-002 Mar 25, 1998   Start Trial   Start Trial
Pharmacia And Upjohn DETROL LA tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 021228-002 Dec 22, 2000   Start Trial   Start Trial
Pharmacia And Upjohn DETROL tolterodine tartrate TABLET;ORAL 020771-002 Mar 25, 1998   Start Trial   Start Trial
Pharmacia And Upjohn DETROL LA tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 021228-001 Dec 22, 2000   Start Trial   Start Trial
Pharmacia And Upjohn DETROL LA tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 021228-002 Dec 22, 2000   Start Trial   Start Trial
Pharmacia And Upjohn DETROL tolterodine tartrate TABLET;ORAL 020771-001 Mar 25, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for tolterodine tartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0325571 C980020 Netherlands   Start Trial PRODUCT NAME: TOLTERODINE, DESGEWENST IN DE VORM VAN EEN ZOUT MET EEN FYSIOLO GISCH ACCEPTABEL ZUUR, IN HET BIJZONDER TOLTERODINE L-TARTRAAT; NAT. REGISTRATION NO/DATE: RVG 22148, RVG 22149 19980217; FIRST REGISTRATION: SE 13475, 13476 19970905
0325571 SPC/GB98/027 United Kingdom   Start Trial PRODUCT NAME: TOLTERODINE OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: SE 13475 19970905; SE 13476 19970905; UK 00032/0222 19980203; UK 00032/0223 19980203
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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