docetaxel · Hospira Inc · NDA 022234, 022312, 022534, 201195, 201525, 202356, 203551, 205934

Docetaxel

Earliest generic entry, as listed · earliest of 12 marketed strengths
30 Sep 2033

9 of 12 marketed strengths have no unexpired patent or exclusivity listed.

Blocked by patent: US 8940786, US 9308195, US 9763880.

Listed patents · 4 unexpired

10 Orange Book listing rows for 4 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 8940786drug product, use U-1789 · sets the listed date30 Sep 2033
US 9308195drug product · sets the listed date30 Sep 2033
US 9763880use U-2558, U-2559, U-2560, U-2561, U-2562, U-2563, U-256430 Sep 2033
US 9763880 listing rowuse U-2558 · sets the listed date30 Sep 2033
US 9763880 listing rowuse U-2559 · sets the listed date30 Sep 2033
US 9763880 listing rowuse U-2560 · sets the listed date30 Sep 2033
US 9763880 listing rowuse U-2561 · sets the listed date30 Sep 2033
US 9763880 listing rowuse U-2562 · sets the listed date30 Sep 2033
US 9763880 listing rowuse U-2563 · sets the listed date30 Sep 2033
US 9763880 listing rowuse U-2564 · sets the listed date30 Sep 2033
US 10842770drug product, use U-29987 Aug 2031

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

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 · 31

NDA · productFormStrengthListed expiry
022234 · 001 · RLDinjectable, injection20MG/2ML (10MG/ML)open
022234 · 002 · RLDinjectable, injection80MG/8ML (10MG/ML)open
022234 · 003 · RLDinjectable, injection160MG/16ML (10MG/ML)open
022234 · 004 · RLDinjectable, injection20MG/ML (20MG/ML)open
022234 · 005 · RLDinjectable, injection80MG/4ML (20MG/ML)open
022234 · 006 · RLD · discontinuedinjectable, injection120MG/6ML (20MG/ML)open
022234 · 007 · RLDinjectable, injection160MG/8ML (20MG/ML)open
022312 · 001 · discontinuedinjectable, injection20MG/0.5ML (40MG/ML)open
022312 · 002 · discontinuedinjectable, injection80MG/2ML (40MG/ML)open
022534 · 003 · discontinuedinjectable, injection20MG/ML (20MG/ML)open
022534 · 004 · discontinuedinjectable, injection80MG/4ML (20MG/ML)open
022534 · 005 · discontinuedinjectable, injection160MG/8ML (20MG/ML)open
201195 · 001 · RLD · discontinuedinjectable, injection20MG/0.5ML (40MG/ML)open
201195 · 002 · RLD · discontinuedinjectable, injection80MG/2ML (40MG/ML)open
201195 · 003 · RLDinjectable, injection20MG/ML (20MG/ML)open
201195 · 004 · RLDinjectable, injection80MG/4ML (20MG/ML)open
201195 · 005 · RLDinjectable, injection160MG/8ML (20MG/ML)open
201525 · 001injectable, injection20MG/2ML (10MG/ML)open
201525 · 002injectable, injection80MG/8ML (10MG/ML)open
201525 · 003injectable, injection160MG/16ML (10MG/ML)open
202356 · 001 · discontinuedinjectable, injection20MG/2ML (10MG/ML)open
202356 · 002 · discontinuedinjectable, injection80MG/8ML (10MG/ML)open
202356 · 003 · discontinuedinjectable, injection130MG/13ML (10MG/ML)open
202356 · 004 · discontinuedinjectable, injection200MG/20ML (10MG/ML)open
203551 · 001injectable, injection20MG/ML (20MG/ML)open
203551 · 002injectable, injection80MG/4ML (20MG/ML)open
203551 · 003injectable, injection140MG/7ML (20MG/ML)open
203551 · 004injectable, injection160MG/8ML (20MG/ML)open
205934 · 001 · RLDinjectable, injection20MG/ML (20MG/ML)30 Sep 2033
205934 · 002 · RLDinjectable, injection80MG/4ML (20MG/ML)30 Sep 2033
205934 · 003 · RLDinjectable, injection160MG/8ML (20MG/ML)30 Sep 2033