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Tofacitinib citrate - Generic Drug Details
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What are the generic drug sources for tofacitinib citrate and what is the scope of patent protection?
Tofacitinib citrate
is the generic ingredient in two branded drugs marketed by Pfizer Inc and Pf Prism Cv, and is included in two NDAs. There are eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Tofacitinib citrate has two hundred and twenty patent family members in sixty countries.
There are twelve drug master file entries for tofacitinib citrate. Two suppliers are listed for this compound.
Summary for tofacitinib citrate
| International Patents: | 220 |
| US Patents: | 8 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 12 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 60 |
| Clinical Trials: | 4 |
| Patent Applications: | 25 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tofacitinib citrate |
| DailyMed Link: | tofacitinib citrate at DailyMed |
Recent Clinical Trials for tofacitinib citrate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hanlim Pharm. Co., Ltd. | Phase 1 |
| Pfizer | Phase 1 |
| Johns Hopkins University | Phase 1 |
Recent Litigation for tofacitinib citrate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Pfizer Inc. v. Ajanta Pharma Ltd. | 2019-03-15 |
| Pfizer Inc. v. Teva Pharmaceuticals USA, Inc. | 2018-12-07 |
| Pfizer Inc. v. Sun Pharmaceutical Industries Limited | 2018-10-03 |
Pharmacology for tofacitinib citrate
| Drug Class | Janus Kinase Inhibitor |
| Mechanism of Action | Janus Kinase Inhibitors |
Synonyms for tofacitinib citrate
| (3R,4R)-4-Methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-?-oxo-1-piperidinepropanenitrile citrate |
| (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-beta-oxo-1-piperidine propanenitrile 2-hydroxy-1,2,3-propanetricarboxylate |
| 1-Piperidinepropanenitrile, 4-methyl-3-(methyl-7H-pyrrolo(2,3-d)pyrimidin-4-ylamino)- beta-oxo-, (3R,4R)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1) |
| 1-PIPERIDINEPROPANENITRILE,4-METHYL-3-(METHYL-7H-PYRROLO[2,3-D]PYRIMIDIN-4-YLAMINO)-BETA-OXO-,(3R,4R)-,2-HYDROXY-1,2,3-PROPANETRICARBOXYLATE(1:1) |
| 2-hydroxypropane-1,2,3-tricarboxylic acid;3-[(3R,4R)-4-methyl-3-[methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl]-3-oxopropanenitrile |
| 3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile 2-hydroxypropane-1,2,3-tricarboxylate |
| 3-((3R,4R)-4-Methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile mono citrate salt |
| 3-{(3r,4r)-4-methyl-3-[methyl-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile citrate salt |
| 3-{(3R,4R)-4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile Mono Citrate Salt |
| 3-{(3R,4R)-4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl}-amino]-piperidin-1-yl)-3-oxo-propionitrile citrate salt |
| 3-{(3R,4R)-4-methyl-3-[methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl}-3-oxopropanenitrile 2-hydroxypropane-1,2,3-tricarboxylate |
| 540737-29-9 |
| AB0033779 |
| AC-25004 |
| AKOS022178222 |
| AOB87768 |
| API0017273 |
| AS-19392 |
| AX8223835 |
| BC600313 |
| C22H28N6O8 |
| CEP-18770(Delanzomib) |
| CHEBI:71197 |
| CHEMBL2103743 |
| citro; tofacitinib |
| CP 690550 citrate |
| CP-690,550-10 |
| CP-690550 - Tofacitinib citrate |
| CP-690550 citrate |
| CP-690550-10 |
| CS-0928 |
| D09783 |
| DTXSID80202404 |
| EX-A204 |
| HY-40354A |
| MLS006010058 |
| MolPort-023-293-518 |
| O1FF4DIV0D |
| PB31590 |
| Q-3287 |
| s5001 |
| SC-12808 |
| SCHEMBL1374185 |
| SMR004701220 |
| ST24050181 |
| SYIKUFDOYJFGBQ-YLAFAASESA-N |
| Tasocitinib citrate |
| Tofacitinib (citrate) |
| Tofacitinib (CP-690550) Citrate |
| Tofacitinib citrate (CP-690550 citrate) |
| Tofacitinib citrate (JAN/USAN) |
| Tofacitinib citrate [USAN] |
| Tofacitinib citrate, >=98% (HPLC) |
| Tofacitinib citrate(CP690550) |
| UNII-O1FF4DIV0D |
| X7518 |
| Xeljanz |
| Xeljanz Xr |
Paragraph IV (Patent) Challenges for TOFACITINIB CITRATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| XELJANZ XR | TABLET, EXTENDED RELEASE;ORAL | tofacitinib citrate | 208246 | 2016-11-07 |
| XELJANZ | TABLET;ORAL | tofacitinib citrate | 203214 |
US Patents and Regulatory Information for tofacitinib citrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer Inc | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-001 | Nov 6, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-002 | May 30, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Pfizer Inc | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Pfizer Inc | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | 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 |
International Patents for tofacitinib citrate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Uruguay | 27317 | Start Trial |
| Denmark | 1451192 | Start Trial |
| Norway | 20035201 | Start Trial |
| Ukraine | 80093 | Start Trial |
| Norway | 323378 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for tofacitinib citrate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1666481 | 37/2017 | Austria | Start Trial | PRODUCT NAME: TOFACITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES CITRATS; REGISTRATION NO/DATE: EU/1/17/1178 (MITTEILUNG) 20170324 |
| 1666481 | C201730033 | Spain | Start Trial | PRODUCT NAME: TOFACITINIB Y SALES FARMACEUTICAMENTE ACEPTABLES DEL MISMO, INCLUYENDO LA SAL CITRATO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1178; DATE OF AUTHORISATION: 20170322; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1178; DATE OF FIRST AUTHORISATION IN EEA: 20170322 |
| 1666481 | LUC00031 | Luxembourg | Start Trial | PRODUCT NAME: TOFACITINIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE SEL DE CITRATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324 |
| 1666481 | 300887 | Netherlands | Start Trial | PRODUCT NAME: TOFACITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER TOFACITINIBCITRAAT; REGISTRATION NO/DATE: EU/1/17/1178 20170324 |
| 1666481 | PA2017025 | Lithuania | Start Trial | PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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LOE / Major Patent Expirations 2019 - 2020
NCE-1 Patent Challenge Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.