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XELJANZ XR Drug Profile
Which patents cover Xeljanz Xr, and what generic alternatives are available?
Xeljanz Xr is a drug marketed by Pfizer Inc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and five patent family members in fifty-eight countries.
The generic ingredient in XELJANZ XR 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.
Summary for XELJANZ XR
International Patents: | 205 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 2 |
Bulk Api Vendors: | 53 |
Clinical Trials: | 6 |
Patent Applications: | 19 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for XELJANZ XR |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XELJANZ XR |
DailyMed Link: | XELJANZ XR at DailyMed |

Pharmacology for XELJANZ XR
Drug Class | Janus Kinase Inhibitor |
Mechanism of Action | Janus Kinase Inhibitors |
Synonyms for XELJANZ XR
(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 |
(3R,4R)-4-METHYL-3-(METHYL-7H-PYRROLO[2,3-D]PYRIMIDIN-4-YLAMINO)-BETA-OXO-1-PIPERIDINEPROPANENITRILE CITRATE SALT |
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) |
1-PIPERIDINEPROPANENITRILE,4-METHYL-3- -BETA-OXO-, -,2-HYDROXY-1,2,3-PROPANETRICARBOXYLATE |
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-OXOPROPANENITRILE 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 |
AK117841 |
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 |
CP-690550-10 CITRATE SALT |
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 |
TASOCITINIB CITRATE SALT |
Tofacitinib (citrate) |
Tofacitinib (CP-690550) Citrate |
Tofacitinib citrate |
Tofacitinib citrate (CP-690550 citrate) |
Tofacitinib citrate (JAN/USAN) |
Tofacitinib citrate [USAN] |
Tofacitinib citrate, >=98% (HPLC) |
Tofacitinib citrate(CP690550) |
TOFACITINIB, CITRATE SALT |
UNII-O1FF4DIV0D |
X7518 |
US Patents and Regulatory Information for XELJANZ XR
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 | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
Pfizer Inc | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
Pfizer Inc | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
Pfizer Inc | XELJANZ XR | tofacitinib citrate | TABLET, EXTENDED RELEASE;ORAL | 208246-001 | Feb 23, 2016 | RX | Yes | Yes | ➤ 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 |
Paragraph IV (Patent) Challenges for XELJANZ XR
Drugname | Dosage | Strength | RLD | Date |
---|---|---|---|---|
➤ Subscribe | Extended-release Tablets | 11 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for XELJANZ XR
Country | Document Number | Estimated Expiration |
---|---|---|
Uruguay | 26477 | ➤ Sign Up |
Mexico | PA03011062 | ➤ Sign Up |
Japan | 2016199602 | ➤ Sign Up |
Georgia, Republic of | P20053479 | ➤ Sign Up |
Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for XELJANZ XR
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|
2017 00035 | Denmark | ➤ Sign Up | PRODUCT NAME: TOFACITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER CITRAT-SALTET; REG. NO/DATE: EU/1/17/1178/001-003 20170324 |
1235830/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: TOFACITINIB; REGISTRATION NO/DATE: SWISSMEDIC 62630 12.07.2013 |
2017025 | Lithuania | ➤ Sign Up | PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322 |
2017000062 | Germany | ➤ Sign Up | PRODUCT NAME: TOFACITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, EINSCHLIESSLICH DES CITRAT-SALZES; REGISTRATION NO/DATE: EU/1/17/1178 20170322 |
Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |