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Fesoterodine fumarate - Generic Drug Details
What are the generic sources for fesoterodine fumarate and what is the scope of fesoterodine fumarate freedom to operate?
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 fifteen 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: | 15 |
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Pharms Usa Inc | FESOTERODINE FUMARATE | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 204946-001 | Oct 3, 2017 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-002 | Oct 31, 2008 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | |
| Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-002 | Oct 31, 2008 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | |
| Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-002 | Oct 31, 2008 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Pfizer | TOVIAZ | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 022030-002 | Oct 31, 2008 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Aurobindo Pharma Ltd | FESOTERODINE FUMARATE | fesoterodine fumarate | TABLET, EXTENDED RELEASE;ORAL | 205007-001 | Feb 17, 2017 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| 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 |
|---|---|---|
| European Patent Office | 1690536 | ➤ Sign Up |
| Japan | 4083431 | ➤ Sign Up |
| Germany | 69902037 | ➤ Sign Up |
| Australia | 778132 | ➤ Sign Up |
| Germany | 122007000065 | ➤ Sign Up |
| Portugal | 1690536 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for fesoterodine fumarate
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C/GB07/053 | United Kingdom | ➤ Sign Up | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/053 GRANTED TO SCHWARZ PHARMA AG IN RESPECT OF THE PRODUCT FESOTERODINE AND ITS SALTS WITH PHYSIOLOGICALLY ACCEPTABLE ACIDS, INCLUDING FUMARIC ACID, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6299 DATED 10 FEBRUARY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23 APRIL 2022. |
| C0050 | France | ➤ Sign Up | PRODUCT NAME: FESOTERODINE ET SES SELS AVEC DES ACIDES PHYSIOLOGIQUEMENT ACCEPTABLES NOTAMMENT L ACIDE FUMARIQUE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/386/001 DU 20070420; REGISTRATION NO/DATE AT EEC: EU/1/07/386/001 DU 20070420 |
| 1077912/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: FESOTERODIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58743 18.12.2008 |
| 2007 00046 | Denmark | ➤ Sign Up | PRODUCT NAME: FESOTERODIN, FUMARAT |
| 2007008,C1230209 | Lithuania | ➤ Sign Up | PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420 |
| C037/2007 | Ireland | ➤ Sign Up | SPC037/2007: 20080507, EXPIRES: 20220419 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
