Applicant, as named in the Orange Book
Hikma
Part of Hikma Pharmaceuticals
Company and ticker: cliffwatch mapping, checked against SEC EDGAR
Next listed expiry: Mitigare on 22 Aug 2033. 7 products with live protection, 30 without.
Products with listed protection
| Drug | Earliest generic entry |
|---|---|
| Mitigare NDA 204820 colchicine | 22 Aug 2033 patent, carve-out possible |
| Kloxxado NDA 212045 naloxone hydrochloride | 26 Aug 2034 patent |
| Tyzavan NDA 211962 · 7 strengths vancomycin hydrochloride | 6 Nov 2035 patent |
| Combogesic Iv NDA 215320 acetaminophen; ibuprofen sodium | 14 Jan 2036 patent |
| Immphentiv NDA 203826 · 2 strengths phenylephrine hydrochloride | 26 Sep 2036 patent |
| Daptomycin NDA 217415 · 2 strengths daptomycin | 9 Jan 2043 patent |
| Hydromorphone Hydrochloride NDA 217812 hydromorphone hydrochloride | 10 Jan 2043 patent |
Recent events
- Morphine Sulfate · Generic approved · ANDA 213892, QuagenApproved 7 Jul 2026Detected 25 Oct 2026
- Reglan · Generic approved · ANDA 217072, Baxter Hlthcare CorpApproved 11 Sep 2026Detected 25 Oct 2026
- Mitigare · Generic approved · ANDA 212880, Micro LabsApproved 17 Feb 2026Detected 25 Oct 2026
- Xopenex · Generic approved · ANDA 215217, NephronApproved 26 May 2026Detected 25 Oct 2026
Products without listed protection (30)
| Drug | Earliest generic entry |
|---|---|
| Acetaminophen NDA 206968 acetaminophen | open now no listed protection |
| Amicar NDA 015230 aminocaproic acid | open now no listed protection |
| Amicar NDA 015197 · 2 strengths aminocaproic acid | open now no listed protection |
| Ativan NDA 018140 · 2 strengths lorazepam | open now no listed protection |
| Cafcit NDA 020793 caffeine citrate | open now no listed protection |
| Cefazolin Sodium NDA 216109 · 2 strengths cefazolin sodium | open now no listed protection |
| Codeine Sulfate NDA 022402 · 3 strengths codeine sulfate | open now no listed protection |
| Cyclophosphamide NDA 203856 · 2 strengths cyclophosphamide | open now no listed protection |
| Daptomycin NDA 209949 daptomycin | open now no listed protection |
| Daunorubicin Hydrochloride NDA 050731 daunorubicin hydrochloride | open now no listed protection |
| Digoxin NDA 021648 digoxin | open now no listed protection |
| Dopram NDA 014879 doxapram hydrochloride | open now no listed protection |
| Duramorph Pf NDA 018565 · 2 strengths morphine sulfate | open now no listed protection |
| Fentanyl Citrate NDA 019101 fentanyl citrate | open now no listed protection |
| Heparin Sodium NDA 017037 · 3 strengths heparin sodium | open now no listed protection |
| Infumorph NDA 018565 · 2 strengths morphine sulfate | open now no listed protection |
| Labetalol Hydrochloride NDA 213330 labetalol hydrochloride | open now no listed protection |
| Labetalol Hydrochloride In Dextrose NDA 213330 labetalol hydrochloride | open now no listed protection |
| Labetalol Hydrochloride In Sodium Chloride NDA 213330 · 3 strengths labetalol hydrochloride | open now no listed protection |
| Lithium Carbonate NDA 017812 · 3 strengths lithium carbonate | open now no listed protection |
| Lithium Carbonate NDA 018558 lithium carbonate | open now no listed protection |
| Methadone Hydrochloride NDA 017058 methadone hydrochloride | open now no listed protection |
| Morphine Sulfate NDA 022207 · 2 strengths morphine sulfate | open now no listed protection |
| Morphine Sulfate NDA 022195 · 3 strengths morphine sulfate | open now no listed protection |
| Oxytocin NDA 018243 · 2 strengths oxytocin | open now no listed protection |
| Pamidronate Disodium NDA 021113 · 2 strengths pamidronate disodium | open now no listed protection |
| Pantoprazole Sodium NDA 209463 pantoprazole sodium | open now no listed protection |
| Phenylephrine Hydrochloride NDA 203826 · 3 strengths phenylephrine hydrochloride | open now no listed protection |
| Robaxin NDA 011790 methocarbamol | open now no listed protection |
| Robinul NDA 017558 glycopyrrolate | open now no listed protection |