XELJANZ Drug Patent Profile
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Which patents cover Xeljanz , and what generic alternatives are available?
Xeljanz is a drug marketed by Pfizer and is included in one NDA. There are four patents protecting this drug and three Paragraph IV challenges.
This drug has seventy-five patent family members in fifty-two countries.
The generic ingredient in XELJANZ is tofacitinib citrate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tofacitinib citrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Xeljanz
A generic version of XELJANZ was approved as tofacitinib citrate by SLAYBACK PHARMA LLC on September 25th, 2023.
Summary for XELJANZ
International Patents: | 75 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for XELJANZ |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XELJANZ |
What excipients (inactive ingredients) are in XELJANZ ? | XELJANZ excipients list |
DailyMed Link: | XELJANZ at DailyMed |
Pharmacology for XELJANZ
Drug Class | Janus Kinase Inhibitor |
Mechanism of Action | Janus Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for XELJANZ
Paragraph IV (Patent) Challenges for XELJANZ
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
XELJANZ | Oral Solution | tofacitinib citrate | 1 mg/mL | 213082 | 1 | 2021-11-12 |
XELJANZ | Tablets | tofacitinib citrate | 10 mg | 203214 | 1 | 2019-07-24 |
XELJANZ | Tablets | tofacitinib citrate | 5 mg | 203214 | 3 | 2016-11-07 |
US Patents and Regulatory Information for XELJANZ
XELJANZ is protected by one US patents and one FDA Regulatory Exclusivity.
Patents protecting XELJANZ
Pyrrolo[2,3-D]pyrimidine compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting XELJANZ
TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS, TO THE PRESCRIBING INFORMATION
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-002 | Dec 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Pfizer | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-002 | Dec 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 XELJANZ
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-001 | Nov 6, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-001 | Nov 6, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer | XELJANZ | tofacitinib citrate | SOLUTION;ORAL | 213082-001 | Sep 25, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
Pf Prism Cv | XELJANZ | tofacitinib citrate | TABLET;ORAL | 203214-001 | Nov 6, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for XELJANZ
See the table below for patents covering XELJANZ around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Argentina | 037635 | FORMAS CRISTALINAS Y AMORFAS DE LA SAL MONOCITRATO DE 3-[4-METIL-3-[METIL-(7H-PIRROLO[2,3-D] PIRIMIDIN-4-IL)-AMINO]- PIPERIDIN-1-IL)-3-OXO-PROPIONITRILO, COMPOSICIONES FARMACEUTICAS QUE LO CONTIENEN, USO EN LA MANUFACTURA DE MEDICAMENTOS Y PROCEDIMIENTO PARA OBTENER UNA FORMA CRISTALIZADA | ⤷ Try a Trial |
New Zealand | 540332 | Optical resolution of (1-benzyl-4-methylpiperidin-3-YL) - methylamine and the use thereof for the preparation of pyrrolo 2,3-pyrimidine derivatives as protein kinases inhibitors | ⤷ Try a Trial |
Denmark | 1666481 | ⤷ Try a Trial | |
Mexico | PA03011062 | RESOLUCION OPTICA DE (1-BENCIL-4-METILPIPERIDIN-3-IL)-METILAMINA Y EL USO DE LA MISMA PARA LA PREPARACION DE DERIVADOS DE PIRROLO 2,3-PIRIMIDINA COMO INHIBIDORES DE PROTEINA QUINASAS. (OPTICAL RESOLUTION OF (1-BENZYL-4-METHYLPIPERIDIN-3-YL) -METHYLAMINE AND THE USE THEREOF FOR THE PREPARATION OF PYRROLO 2,3-PYRIMIDINE DERIVATIVES AS PROTEIN KINASES INHIBITORS.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XELJANZ
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1666481 | 2017/036 | Ireland | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE CITRATE SALT; REGISTRATION NO/DATE: EU/1/17/1178/001 EU/1/17/1178/004 20170322 |
1666481 | 122017000062 | Germany | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322 |
1666481 | PA2017025 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322 |
1666481 | C201730033 | Spain | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |