cliffwatch

upadacitinib · Abbvie · NDA 211675

Rinvoq

Earliest generic entry, as listed · earliest of 3 marketed strengths
9 Mar 2038

Blocked by patent: US 11564922, US 11607411. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 45 unexpired

61 Orange Book listing rows for 45 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 11564922use U-3624, U-43039 Mar 2038
US 11564922 listing rowuse U-3624 · sets the listed date9 Mar 2038
US 11564922 listing rowuse U-4303 · sets the listed date9 Mar 2038
US 11607411use U-3341, U-43029 Mar 2038
US 11607411 listing rowuse U-3341 · sets the listed date9 Mar 2038
US 11607411 listing rowuse U-4302 · sets the listed date9 Mar 2038
US 10202393drug product17 Oct 2036
US 10344036drug product17 Oct 2036
US 10519164drug product17 Oct 2036
US 10550126use U-329817 Oct 2036
US 10597400use U-325517 Oct 2036
US 10730883drug product17 Oct 2036
US 10981923drug substance17 Oct 2036
US 10981924drug product17 Oct 2036
US 10995095use U-329817 Oct 2036
US 11186584drug substance17 Oct 2036
US 11198697drug product17 Oct 2036
US 11365198use U-3275, U-394617 Oct 2036
US 11365198 listing rowuse U-327517 Oct 2036
US 11365198 listing rowuse U-394617 Oct 2036
US 11512092use U-3275, U-3371, U-3487, U-394617 Oct 2036
US 11512092 listing rowuse U-327517 Oct 2036
US 11512092 listing rowuse U-337117 Oct 2036
US 11512092 listing rowuse U-348717 Oct 2036
US 11512092 listing rowuse U-394617 Oct 2036
US 11524964use U-337117 Oct 2036
US 11535624use U-325517 Oct 2036
US 11535625use U-329817 Oct 2036
US 11535626use U-329817 Oct 2036
US 11661425drug substance, drug product17 Oct 2036
US 11680069drug substance, drug product17 Oct 2036
US 11718627drug substance, drug product17 Oct 2036
US 11767326use U-329817 Oct 2036
US 11773105drug substance, drug product17 Oct 2036
US 11773106use U-3275, U-3371, U-3487, U-394617 Oct 2036
US 11773106 listing rowuse U-327517 Oct 2036
US 11773106 listing rowuse U-337117 Oct 2036
US 11773106 listing rowuse U-348717 Oct 2036
US 11773106 listing rowuse U-394617 Oct 2036
US 11780847drug product17 Oct 2036
US 11780848use U-337117 Oct 2036
US 11787815drug product17 Oct 2036
US 11795175use U-325517 Oct 2036
US 11976077use U-329817 Oct 2036
US 11993605use U-3275, U-394617 Oct 2036
US 11993605 listing rowuse U-327517 Oct 2036
US 11993605 listing rowuse U-394617 Oct 2036
US 11993606use U-348717 Oct 2036
US 12077545drug product17 Oct 2036
US 12091415drug product17 Oct 2036
US 12103933drug product17 Oct 2036
US 12110297drug product17 Oct 2036
US 12110298drug substance, drug product17 Oct 2036
US 12116373drug product17 Oct 2036
US 12134621drug product17 Oct 2036
US 12365689use U-394517 Oct 2036
US 12570664use U-445417 Oct 2036
US 9951080drug substance, drug product17 Oct 2036
US 9963459drug product17 Oct 2036
US RE47221drug substance16 Aug 2033
US 8962629drug substance, use U-3255, U-3275, U-3341, U-3371, U-3624, U-3945, U-394615 Jan 2031
US 8962629 listing rowdrug substance, use U-325515 Jan 2031
US 8962629 listing rowdrug substance, use U-327515 Jan 2031
US 8962629 listing rowdrug substance, use U-334115 Jan 2031
US 8962629 listing rowdrug substance, use U-337115 Jan 2031
US 8962629 listing rowdrug substance, use U-362415 Jan 2031
US 8962629 listing rowdrug substance, use U-394515 Jan 2031
US 8962629 listing rowdrug substance, use U-394615 Jan 2031

Exclusivities · 5 unexpired

ODE-538orphan drug (7 years)28 Apr 2032
ODE-481orphan drug (7 years)26 Apr 2031
I-966new indication (3 years)28 Apr 2028
I-946new indication (3 years)26 Apr 2027
NPPnew patient population26 Apr 2027

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 3

NDA · productFormStrengthListed expiry
211675 · 001 · RLDtablet, extended release, oral15MG9 Mar 2038
211675 · 002 · RLDtablet, extended release, oral30MG9 Mar 2038
211675 · 003 · RLDtablet, extended release, oral45MG9 Mar 2038
Expired or delisted (1)
  • I-919 · 18 May 2026