Applicant, as named in the Orange Book

Fresenius Kabi Usa

Part of Fresenius SE & Co. KGaA

Company and ticker: cliffwatch mapping, checked against SEC EDGAR

Next listed expiry: Naropin on 28 Nov 2026. 10 products with live protection, 29 without.

Products with listed protection

DrugEarliest generic entry
Naropin
NDA 020533 · 11 strengths
ropivacaine hydrochloride
28 Nov 2026
patent
Levothyroxine Sodium
NDA 202231 · 3 strengths
levothyroxine sodium
3 Oct 2032
patent
Dilaudid
NDA 019034 · 5 strengths
hydromorphone hydrochloride
12 Mar 2034
patent
Dilaudid-Hp
NDA 019034
hydromorphone hydrochloride
12 Mar 2034
patent
Morphine Sulfate
NDA 204223 · 3 strengths
morphine sulfate
12 Mar 2034
patent
Kabiven In Plastic Container
NDA 200656 · 4 strengths
amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil
3 May 2036
patent
Perikabiven In Plastic Container
NDA 200656 · 3 strengths
amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil
3 May 2036
patent
Levothyroxine Sodium
NDA 210632 · 3 strengths
levothyroxine sodium
1 Dec 2036
patent
Potassium Phosphates In 0.9% Sodium Chloride
NDA 212832 · 2 strengths
potassium phosphate, dibasic; potassium phosphate, monobasic
12 Oct 2041
patent
Epinephrine
NDA 215425
epinephrine
17 Jan 2045
patent

Recent events

  • Calcium Gluconate · Generic approved · ANDA 217891, CiplaApproved 17 Sep 2026Detected 25 Oct 2026
  • Xylocaine Preservative Free · Generic approved · ANDA 220071, Viwit PharmApproved 19 Mar 2026Detected 25 Oct 2026
  • Diprivan · Generic approved · ANDA 217945, Emerge BioscienceApproved 2 Dec 2025Detected 25 Oct 2026
  • Diprivan · Generic approved · ANDA 220857, AdaptisApproved 14 Jul 2026Detected 25 Oct 2026
  • Magnesium Sulfate · Generic approved · ANDA 217461, AdaptisApproved 9 Jul 2026Detected 25 Oct 2026
  • Sensorcaine · Generic approved · ANDA 220493, AdaptisApproved 22 Apr 2026Detected 25 Oct 2026
  • Xylocaine Viscous · Generic approved · ANDA 218676, QuagenApproved 20 Mar 2026Detected 25 Oct 2026
  • Naropin · Enters 12-month window basis: patentListed date 28 Nov 2026Detected 24 Oct 2026
  • Naropin · Enters 12-month window basis: patentListed date 28 Nov 2026Detected 24 Oct 2026
Products without listed protection (29)
DrugEarliest generic entry
Atropine Sulfate
NDA 209260
atropine sulfate
open now
no listed protection
Calcium Gluconate
NDA 208418 · 3 strengths
calcium gluconate
open now
no listed protection
Diprivan
NDA 019627
propofol
open now
no listed protection
Glucagon
NDA 201849 · 2 strengths
glucagon hydrochloride
open now
no listed protection
Glycophos
NDA 220381 · 2 strengths
sodium glycerophosphate
open now
no listed protection
Glycopyrrolate
NDA 214919
glycopyrrolate
open now
no listed protection
Heparin Sodium
NDA 017651
heparin sodium
open now
no listed protection
Heparin Sodium
NDA 017029 · 4 strengths
heparin sodium
open now
no listed protection
Heparin Sodium 25,000 Units In Dextrose 5%
NDA 017029 · 2 strengths
heparin sodium
open now
no listed protection
Heparin Sodium 25,000 Units In Sodium Chloride 0.45%
NDA 017029 · 2 strengths
heparin sodium
open now
no listed protection
Heparin Sodium In Plastic Container
NDA 017029 · 4 strengths
heparin sodium
open now
no listed protection
Heparin Sodium Preservative Free
NDA 017029 · 2 strengths
heparin sodium
open now
no listed protection
Indomethacin
NDA 022536
indomethacin
open now
no listed protection
Magnesium Sulfate
NDA 019316 · 4 strengths
magnesium sulfate
open now
no listed protection
Moxifloxacin Hydrochloride
NDA 205572
moxifloxacin hydrochloride
open now
no listed protection
Nebupent
NDA 019887
pentamidine isethionate
open now
no listed protection
Neostigmine Methylsulfate
NDA 203629 · 3 strengths
neostigmine methylsulfate
open now
no listed protection
Nesacaine
NDA 009435
chloroprocaine hydrochloride
open now
no listed protection
Nesacaine-Mpf
NDA 009435 · 2 strengths
chloroprocaine hydrochloride
open now
no listed protection
Omegaven
NDA 210589 · 2 strengths
fish oil triglycerides
open now
no listed protection
Oxytocin
NDA 018248 · 3 strengths
oxytocin
open now
no listed protection
Pentam
NDA 019264
pentamidine isethionate
open now
no listed protection
Potassium Phosphates
NDA 212832 · 3 strengths
potassium phosphate, dibasic; potassium phosphate, monobasic
open now
no listed protection
Rocuronium Bromide
NDA 217472 · 2 strengths
rocuronium bromide
open now
no listed protection
Sensorcaine
NDA 018304 · 3 strengths
bupivacaine hydrochloride
open now
no listed protection
Sensorcaine
NDA 018304 · 2 strengths
bupivacaine hydrochloride; epinephrine bitartrate
open now
no listed protection
Smoflipid 20%
NDA 207648 · 4 strengths
fish oil; medium chain triglycerides; olive oil; soybean oil
open now
no listed protection
Xylocaine
NDA 006488 · 4 strengths
lidocaine hydrochloride
open now
no listed protection
Xylocaine W/ Epinephrine
NDA 006488 · 6 strengths
epinephrine; lidocaine hydrochloride
open now
no listed protection