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Fesoterodine fumarate - Generic Drug Details
What are the generic drug sources for fesoterodine fumarate and what is the scope of fesoterodine fumarate patent protection?
Fesoterodine fumarate
is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Zydus Pharms Usa Inc, and Pfizer, and is included in four NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Fesoterodine fumarate has one hundred and thirty-one patent family members in thirty-three countries.
There are fourteen drug master file entries for fesoterodine fumarate. Six suppliers are listed for this compound. There are nine tentative approvals for this compound.
Summary for fesoterodine fumarate
| International Patents: | 131 |
| US Patents: | 8 |
| Tradenames: | 2 |
| Applicants: | 4 |
| NDAs: | 4 |
| Drug Master File Entries: | 14 |
| Suppliers / Packagers: | 6 |
| Bulk Api Vendors: | 45 |
| Clinical Trials: | 10 |
| Patent Applications: | 15 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for fesoterodine fumarate |
| DailyMed Link: | fesoterodine fumarate at DailyMed |
Synonyms for fesoterodine fumarate
| (E)-but-2-enedioic acid;[2-[(1R)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl] 2-methylpropanoate |
| (R)-Fesoterodine fumarate |
| [2-[(1R)-3-(diisopropylamino)-1-phenyl-propyl]-4-(hydroxymethyl)phenyl] 2-methylpropanoate; fumaric acid |
| 2-((1R)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl 2-methylpropanoate hydrogen (2E)-butenedioate (salt) |
| 2-((1R)-3-(Diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl isobutyrate |
| 286930-03-8 |
| 930F038 |
| ABP000771 |
| AC-3486 |
| AK323629 |
| AKOS005146248 |
| AKOS015855886 |
| AN-490 |
| AT-36463 |
| BC244477 |
| BCP9000682 |
| BCPP000231 |
| C26H37NO3.C4H4O4 |
| CHEMBL1201765 |
| CS-0822 |
| D08923 |
| EOS72165S7 |
| Fesoterodine fumarate - Toviaz |
| Fesoterodine fumarate (JAN/USP) |
| Fesoterodine fumarate [USAN:JAN] |
| Fesoterodine fumarate [USAN] |
| Fesoterodine fumarate, Toviaz |
| Fesoterodine fumarate/ |
| Fesoterodine fumarate|286930-03-8 |
| Fesoterodine maleate |
| fesoterodine; fumaric acid |
| Fesoterodinefumarate |
| Fesoterodinefumarate;(R)-Fesoterodine Fumarate;2-Methylpropanoic Acid 2-[(1R)-3-[Bis(1-methylethyl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl Ester (2E)-2-Butenedioate |
| HY-A0030 |
| KB-51873 |
| KS-1298 |
| LS-184117 |
| MFCD12756004 |
| MLS003915638 |
| MolPort-006-394-111 |
| MWHXMIASLKXGBU-RNCYCKTQSA-N |
| PF-00695838 |
| Propanoic acid, 2-methyl-, 2-((1R)-3-(bis(1-methylethyl)amino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl ester, (2E)-2-butenedioate (1:1) (salt) |
| s2240 |
| SCHEMBL1993632 |
| SCHEMBL814971 |
| SMR002544691 |
| SPM 8272 |
| SPM 907 |
| SPM-8272 |
| SPM-907 |
| Toviaz |
| Toviaz (TN) |
| UNII-EOS72165S7 |
| X5023 |
Tentative approvals for FESOTERODINE FUMARATE
| Applicant | Application No. | Strength | Dosage Form |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 8MG | TABLET, EXTENDED RELEASE;ORAL |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 4MG | TABLET, EXTENDED RELEASE;ORAL |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 8MG | TABLET, EXTENDED RELEASE;ORAL |
US Patents and Regulatory Information for fesoterodine fumarate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-001 | Oct 31, 2008 | AB | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | |
| Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-002 | Oct 31, 2008 | AB | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | ||
| Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-001 | Oct 31, 2008 | AB | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | |
| Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-001 | Oct 31, 2008 | AB | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ 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 |
International Patents for fesoterodine fumarate
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 5503393 | ➤ Try a Free Trial |
| Japan | 2014111589 | ➤ Try a Free Trial |
| Hungary | 0600760 | ➤ Try a Free Trial |
| Spain | 2181443 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for fesoterodine fumarate
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 1077912/01 | Switzerland | ➤ Try a Free Trial | PRODUCT NAME: FESOTERODIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58743 18.12.2008 |
| 2007 00046 | Denmark | ➤ Try a Free Trial | PRODUCT NAME: FESOTERODIN, FUMARAT |
| 2007008,C1230209 | Lithuania | ➤ Try a Free Trial | PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420 |
| 8 | Finland | ➤ Try a Free Trial | |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
