Hikma Drug Patent Portfolio
Hikma owns 10 orange book drugs protected by 35 US patents with Levothyroxine Sodium having the least patent protection, holding only 1 patent. And Kloxxado with maximum patent protection, holding 7 patents. Given below is the list of Hikma's drug patents along with their expiration dates.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US12295932 | Succinylcholine chloride prefilled syringe | 02 Nov, 2041 | Active |
| US11759497 | Daptomycin formulations | 28 Aug, 2038 | Active |
| US12053502 | Daptomycin formulations | 28 Aug, 2038 | Active |
| US11213480 | Phenylephrine hydrochloride ready-to-use solution | 26 Sep, 2036 | Active |
| US12257342 | Phenylephrine hydrochloride ready-to-use solution | 26 Sep, 2036 | Active |
| US11471400 | Phenylephrine hydrochloride ready-to-use solution | 05 Aug, 2036 | Active |
| US11154498 | Stabilized liquid formulation of levothyroxine | 20 Jul, 2036 | Active |
| US11213498 | Aqueous formulation comprising paracetamol and ibuprofen | 14 Jan, 2036 | Active |
| US10039804 | Glycopeptide compositions | 06 Nov, 2035 | Active |
| US10188697 | Glycopeptide compositions | 06 Nov, 2035 | Active |
| US10849956 | Glycopeptide compositions | 06 Nov, 2035 | Active |
| US11517609 | Glycopeptide compositions | 06 Nov, 2035 | Active |
| US11628200 | Glycopeptide compositions | 06 Nov, 2035 | Active |
| US12161690 | Glycopeptide compositions | 06 Nov, 2035 | Active |
| US11000567 | Glycopeptide compositions | 06 Nov, 2035 | Active |
| US11389416 | Aqueous formulation comprising paracetamol and ibuprofen | 17 Jul, 2035 | Active |
| US12083087 | Aqueous formulation comprising paracetamol and ibuprofen | 17 Jul, 2035 | Active |
| US10722510 | Liquid naloxone spray | 26 Aug, 2034 | Active |
| US10973814 | Liquid naloxone spray | 26 Aug, 2034 | Active |
| US11135155 | Liquid naloxone spray | 26 Aug, 2034 | Active |
| US11617713 | Liquid naloxone spray | 26 Aug, 2034 | Active |
| US11628139 | Liquid naloxone spray | 26 Aug, 2034 | Active |
| US11975096 | Liquid naloxone spray | 26 Aug, 2034 | Active |
| US12414915 | Liquid Naloxone Spray | 26 Aug, 2034 | Active |
| US8927607 | Methods of colchicine administration | 22 Aug, 2033 | Active |
| US9399036 | Methods of colchicine administration | 22 Aug, 2033 | Active |
| US9555029 | Methods of colchicine administration | 22 Aug, 2033 | Active |
| US9675613 | Methods of colchicine administration | 22 Aug, 2033 | Active |
| US9789108 | Methods of colchicine administration | 22 Aug, 2033 | Active |
| US11446266 | Combination composition | 26 Oct, 2031 | Active |
| US11896567 | Combination composition | 26 Oct, 2031 | Active |
| US12220392 | Combination Composition | 26 Oct, 2031 | Active |
| US6451289 | Albuterol formulations | 21 Mar, 2021 | Expired |
| US5547994 | Method for treating asthma using optically pure R(-) albuterol | 20 Aug, 2013 | Expired |
| US5362755 | Method for treating asthma using optically pure (R)-albuterol | 25 Mar, 2013 | Expired |
Latest Legal Activities on Hikma's Drug Patents
Given below is the list of recent legal activities going on the following drug patents of Hikma.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification | 04 Sep, 2025 | US12414915 |
| Issue Notification Mailed | 03 Sep, 2025 | US12414915 |
| Application Is Considered Ready for Issue | 26 Aug, 2025 | US12414915 |
| Dispatch to FDC | 26 Aug, 2025 | US12414915 |
| Mail Response to 312 Amendment (PTO-271) | 25 Aug, 2025 | US12414915 |
| Email Notification | 25 Aug, 2025 | US12414915 |
| Response to Amendment under Rule 312 | 21 Aug, 2025 | US12414915 |
| Pubs Case Remand to TC | 20 Aug, 2025 | US12414915 |
| Issue Fee Payment Received | 18 Aug, 2025 | US12414915 |
| Issue Fee Payment Verified | 18 Aug, 2025 | US12414915 |
| Amendment after Notice of Allowance (Rule 312) | 18 Aug, 2025 | US12414915 |
| Email Notification | 30 Jul, 2025 | US12414915 |
| Mail PUB other miscellaneous communication to applicant | 29 Jul, 2025 | US12414915 |
| PUB Other miscellaneous communication to applicant | 28 Jul, 2025 | US12414915 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Jul, 2025 | US11241382 |
Hikma Drug Patents' Oppositions Filed in EPO
Hikma drug patents have faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 01, 2020, by Df-Mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte Parg Mbb. This opposition was filed on patent number EP15791287A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15791287A | Oct, 2020 | df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte ParG mbB | Revoked |
Hikma's Family Patents
Recent FDA approvals and tentative approvals for Hikma
This section lists recent FDA approvals and tentative approvals for Lupin, covering innovator and generic drugs with key regulatory details and timelines.
Generic drugs
Includes generic drug submissions with tentative FDA approvals, not yet marketable due to patent or exclusivity restrictions.
| Drug Name | Submission class (FDA) | Submission Category | Submission Date |
|---|---|---|---|
| Enzalutamide |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | - | 02 Feb, 2026 |
| Sugammadex |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | - | 27 Jun, 2025 |
| Testosterone Undecanoate |
ORIG-1
ⓘ
Orig = Original submission Suppl = Supplement submission Number = submission sequence | - | 09 Dec, 2016 |
Hikma Drug List
Given below is the complete list of Hikma's drugs and the patents protecting them.
1. Combogesic Iv
Combogesic Iv is protected by 6 patents, out of which none have expired yet. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US11213498 | Aqueous formulation comprising paracetamol and ibuprofen |
14 Jan, 2036
(9 years from now)
| Active |
| US11389416 | Aqueous formulation comprising paracetamol and ibuprofen |
17 Jul, 2035
(9 years from now)
| Active |
| US12083087 | Aqueous formulation comprising paracetamol and ibuprofen |
17 Jul, 2035
(9 years from now)
| Active |
| US11446266 | Combination composition |
26 Oct, 2031
(5 years from now)
| Active |
| US11896567 | Combination composition |
26 Oct, 2031
(5 years from now)
| Active |
| US12220392 | Combination Composition |
26 Oct, 2031
(5 years from now)
| Active |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Combogesic Iv's drug page
2. Daptomycin
Daptomycin is protected by 2 patents, out of which none have expired yet. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US11759497 | Daptomycin formulations |
28 Aug, 2038
(12 years from now)
| Active |
| US12053502 | Daptomycin formulations |
28 Aug, 2038
(12 years from now)
| Active |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Daptomycin's drug page
3. Immphentiv
Immphentiv is protected by 3 patents, out of which none have expired yet. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US11213480 | Phenylephrine hydrochloride ready-to-use solution |
26 Sep, 2036
(10 years from now)
| Active |
| US12257342 | Phenylephrine hydrochloride ready-to-use solution |
26 Sep, 2036
(10 years from now)
| Active |
| US11471400 | Phenylephrine hydrochloride ready-to-use solution |
05 Aug, 2036
(10 years from now)
| Active |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Immphentiv's drug page
4. Kloxxado
Kloxxado is protected by 7 patents, out of which none have expired yet. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US10722510 | Liquid naloxone spray |
26 Aug, 2034
(8 years from now)
| Active |
| US10973814 | Liquid naloxone spray |
26 Aug, 2034
(8 years from now)
| Active |
| US11135155 | Liquid naloxone spray |
26 Aug, 2034
(8 years from now)
| Active |
| US11617713 | Liquid naloxone spray |
26 Aug, 2034
(8 years from now)
| Active |
| US11628139 | Liquid naloxone spray |
26 Aug, 2034
(8 years from now)
| Active |
| US11975096 | Liquid naloxone spray |
26 Aug, 2034
(8 years from now)
| Active |
| US12414915 | Liquid Naloxone Spray |
26 Aug, 2034
(8 years from now)
| Active |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Kloxxado's drug page
5. Levothyroxine Sodium
Levothyroxine Sodium is protected by 1 patent, which is still active. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US11154498 | Stabilized liquid formulation of levothyroxine |
20 Jul, 2036
(10 years from now)
| Active |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Levothyroxine Sodium's drug page
Explore Our Curated Drug Screens
6. Mitigare
Mitigare is protected by 5 patents, out of which none have expired yet. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US8927607 | Methods of colchicine administration |
22 Aug, 2033
(7 years from now)
| Active |
| US9399036 | Methods of colchicine administration |
22 Aug, 2033
(7 years from now)
| Active |
| US9555029 | Methods of colchicine administration |
22 Aug, 2033
(7 years from now)
| Active |
| US9675613 | Methods of colchicine administration |
22 Aug, 2033
(7 years from now)
| Active |
| US9789108 | Methods of colchicine administration |
22 Aug, 2033
(7 years from now)
| Active |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Mitigare's drug page
7. Succinylcholine Chloride
Succinylcholine Chloride is protected by 1 patent, which is still active. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US12295932 | Succinylcholine chloride prefilled syringe |
02 Nov, 2041
(15 years from now)
| Active |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Succinylcholine Chloride's drug page
8. Tyzavan
Tyzavan is protected by 6 patents, out of which none have expired yet. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US10039804 | Glycopeptide compositions |
06 Nov, 2035
(9 years from now)
| Active |
| US10188697 | Glycopeptide compositions |
06 Nov, 2035
(9 years from now)
| Active |
| US10849956 | Glycopeptide compositions |
06 Nov, 2035
(9 years from now)
| Active |
| US11517609 | Glycopeptide compositions |
06 Nov, 2035
(9 years from now)
| Active |
| US11628200 | Glycopeptide compositions |
06 Nov, 2035
(9 years from now)
| Active |
| US12161690 | Glycopeptide compositions |
06 Nov, 2035
(9 years from now)
| Active |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Tyzavan's drug page
9. Vancomycin
Vancomycin is protected by 5 patents, out of which none have expired yet. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US10039804 | Glycopeptide compositions |
06 Nov, 2035
(9 years from now)
| Active |
| US10188697 | Glycopeptide compositions |
06 Nov, 2035
(9 years from now)
| Active |
| US10849956 | Glycopeptide compositions |
06 Nov, 2035
(9 years from now)
| Active |
| US11000567 | Glycopeptide compositions |
06 Nov, 2035
(9 years from now)
| Active |
| US11517609 | Glycopeptide compositions |
06 Nov, 2035
(9 years from now)
| Active |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Vancomycin's drug page
10. Xopenex
Xopenex is protected by 3 patents, out of which all have expired. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US6451289 | Albuterol formulations |
21 Mar, 2021
(4 years ago)
| Expired |
| US5547994 | Method for treating asthma using optically pure R(-) albuterol |
20 Aug, 2013
(12 years ago)
| Expired |
| US5362755 | Method for treating asthma using optically pure (R)-albuterol |
25 Mar, 2013
(12 years ago)
| Expired |
Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Xopenex's drug page