Amneal Drug Patent Portfolio
Amneal owns 5 orange book drugs protected by 30 US patents with Tigecycline having the least patent protection, holding only 2 patents. And Ongentys with maximum patent protection, holding 9 patents. Given below is the list of Amneal's drug patents along with their expiration dates.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US11491125 | Baclofen formulations and methods of minimizing patient exposure to metabolite variations | 29 Sep, 2041 | Active |
| US11850225 | Baclofen formulations and methods of minimizing patient exposure to metabolite variations | 29 Sep, 2041 | Active |
| US10792262 | Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives | 29 Jul, 2039 | Active |
| US11654124 | Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives | 29 Jul, 2039 | Active |
| US11931328 | Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives | 29 Jul, 2039 | Active |
| US10881617 | Extended release compositions comprising pyridostigmine | 18 Jun, 2038 | Active |
| US10925833 | Extended release compositions comprising pyridostigmine | 18 Jun, 2038 | Active |
| US10987311 | Extended release compositions comprising pyridostigmine | 18 Jun, 2038 | Active |
| US11229606 | Extended release compositions comprising pyridostigmine | 18 Jun, 2038 | Active |
| US11478425 | Extended release compositions comprising pyridostigmine | 18 Jun, 2038 | Active |
| US11666536 | Extended release compositions comprising pyridostigmine | 18 Jun, 2038 | Active |
| US11911515 | Extended release compositions comprising pyridostigmine | 18 Jun, 2038 | Active |
| US12042559 | Gastroretentive dosage forms for sustained drug delivery | 18 Jun, 2038 | Active |
| US10357468 | Medicaments for slowing Parkinson's disease | 27 May, 2035 | Active |
| US9855335 | Tigecycline composition for injection | 07 Apr, 2033 | Active |
| US9855355 | Method and device for plasma-treating hollow bodies | 07 Apr, 2033 | Active |
| US9630955 | Chemical compound useful as intermediate for preparing a catechol-O-methyltransferase inhibitor | 12 Dec, 2032 | Active |
| US10071085 | Pharmaceutical formulations comprising nitrocatechol derivatives and methods of making thereof | 31 Mar, 2030 | Active |
| US10583130 | Pharmaceutical formulations compromising nitrocatechol derivatives and methods of making thereof | 31 Mar, 2030 | Active |
| US8524746 | Dosage regimen for COMT inhibitors | 14 Jul, 2029 | Active |
| US8168793 | Nitrocatechol derivatives as COMT inhibitors | 02 Apr, 2029 | Active |
| US9745290 | Dosage regimen for COMT inhibitors | 10 Oct, 2027 | Active |
| US8907099 | Nitrocatechol derivatives as COMT inhibitors | 12 May, 2027 | Active |
| US9550759 | Nitrocatechol derivatives as COMT inhibitors | 26 Jul, 2026 | Active |
| US6750237 | Pharmaceutical formulations containing zolmitriptan | 28 May, 2021 | Expired |
| US7220767 | Pharmaceutical formulations containing zolmitriptan | 28 May, 2021 | Expired |
| US6750237 | Pharmaceutical formulations containing zolmitriptan | 28 Nov, 2020 | Expired |
| US7220767 | Pharmaceutical formulations containing zolmitriptan | 28 Nov, 2020 | Expired |
| US5466699 | Indolyl compounds for treating migraine | 14 May, 2013 | Expired |
| US5466699 | Indolyl compounds for treating migraine | 14 Nov, 2012 | Expired |
Latest Legal Activities on Amneal's Drug Patents
Given below is the list of recent legal activities going on the following drug patents of Amneal.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Jul, 2024 | US9550759 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Jul, 2024 | US8372995 (Litigated) |
| Mail Patent eCofC Notification | 14 May, 2024 | US11850225 |
| Recordation of Patent eCertificate of Correction | 14 May, 2024 | US11850225 |
| Patent eCofC Notification | 14 May, 2024 | US11850225 |
|
Email Notification
Critical
| 14 May, 2024 | US11850225 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Apr, 2024 | US10792262 |
| Patent eGrant Notification | 19 Mar, 2024 | US11931328 |
|
Email Notification
Critical
| 19 Mar, 2024 | US11931328 |
| Recordation of Patent eGrant | 19 Mar, 2024 | US11931328 |
|
Patent Issue Date Used in PTA Calculation
Critical
| 19 Mar, 2024 | US11931328 |
|
Recordation of Patent Grant Mailed
Critical
| 19 Mar, 2024 | US11931328 |
| Mail Patent eGrant Notification | 19 Mar, 2024 | US11931328 |
|
Email Notification
Critical
| 29 Feb, 2024 | US11931328 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US8168793 |
Amneal's Drug Patent Litigations
Amneal's drugs have been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 28, 2015, against patent number US6750237. The petitioner Lannett Holdings, Inc., challenged the validity of this patent, with AstraZeneca AB as the respondent. Click below to track the latest information on how companies are challenging Amneal's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7220767 | July, 2015 |
Terminated-Denied
(02 Feb, 2016)
| AstraZeneca AB | Lannett Holdings, Inc. |
| US6750237 | July, 2015 |
Terminated-Denied
(27 Jan, 2016)
| AstraZeneca AB | Lannett Holdings, Inc. |
Amneal's Family Patents
Amneal Drug List
Given below is the complete list of Amneal's drugs and the patents protecting them.
1. Lyvispah
Lyvispah 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 |
|---|---|---|---|
| US11491125 | Baclofen formulations and methods of minimizing patient exposure to metabolite variations |
29 Sep, 2041
(16 years from now)
| Active |
| US11850225 | Baclofen formulations and methods of minimizing patient exposure to metabolite variations |
29 Sep, 2041
(16 years from now)
| Active |
| US10792262 | Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives |
29 Jul, 2039
(14 years from now)
| Active |
| US11654124 | Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives |
29 Jul, 2039
(14 years from now)
| Active |
| US11931328 | Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives |
29 Jul, 2039
(14 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 Lyvispah's drug page
2. Ongentys
Ongentys is protected by 9 patents, out of which none have expired yet. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US10357468 | Medicaments for slowing Parkinson's disease |
27 May, 2035
(10 years from now)
| Active |
| US9630955 | Chemical compound useful as intermediate for preparing a catechol-O-methyltransferase inhibitor |
12 Dec, 2032
(7 years from now)
| Active |
| US10071085 | Pharmaceutical formulations comprising nitrocatechol derivatives and methods of making thereof |
31 Mar, 2030
(5 years from now)
| Active |
| US10583130 | Pharmaceutical formulations compromising nitrocatechol derivatives and methods of making thereof |
31 Mar, 2030
(5 years from now)
| Active |
| US8524746 | Dosage regimen for COMT inhibitors |
14 Jul, 2029
(4 years from now)
| Active |
| US8168793 | Nitrocatechol derivatives as COMT inhibitors |
02 Apr, 2029
(4 years from now)
| Active |
| US9745290 | Dosage regimen for COMT inhibitors |
10 Oct, 2027
(2 years from now)
| Active |
| US8907099 | Nitrocatechol derivatives as COMT inhibitors |
12 May, 2027
(2 years from now)
| Active |
| US9550759 | Nitrocatechol derivatives as COMT inhibitors |
26 Jul, 2026
(1 year, 6 months 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 Ongentys's drug page
3. Pyridostigmine Bromide
Pyridostigmine Bromide is protected by 8 patents, out of which none have expired yet. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US10881617 | Extended release compositions comprising pyridostigmine |
18 Jun, 2038
(13 years from now)
| Active |
| US10925833 | Extended release compositions comprising pyridostigmine |
18 Jun, 2038
(13 years from now)
| Active |
| US10987311 | Extended release compositions comprising pyridostigmine |
18 Jun, 2038
(13 years from now)
| Active |
| US11229606 | Extended release compositions comprising pyridostigmine |
18 Jun, 2038
(13 years from now)
| Active |
| US11478425 | Extended release compositions comprising pyridostigmine |
18 Jun, 2038
(13 years from now)
| Active |
| US11666536 | Extended release compositions comprising pyridostigmine |
18 Jun, 2038
(13 years from now)
| Active |
| US11911515 | Extended release compositions comprising pyridostigmine |
18 Jun, 2038
(13 years from now)
| Active |
| US12042559 | Gastroretentive dosage forms for sustained drug delivery |
18 Jun, 2038
(13 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 Pyridostigmine Bromide's drug page
4. Tigecycline
Tigecycline 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 |
|---|---|---|---|
| US9855335 | Tigecycline composition for injection |
07 Apr, 2033
(8 years from now)
| Active |
| US9855355 | Method and device for plasma-treating hollow bodies |
07 Apr, 2033
(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 Tigecycline's drug page
5. Zomig
Zomig is protected by 6 patents, out of which all have expired. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US6750237
(Pediatric)
| Pharmaceutical formulations containing zolmitriptan |
28 May, 2021
(3 years ago)
| Expired |
| US7220767
(Pediatric)
| Pharmaceutical formulations containing zolmitriptan |
28 May, 2021
(3 years ago)
| Expired |
| US6750237 | Pharmaceutical formulations containing zolmitriptan |
28 Nov, 2020
(4 years ago)
| Expired |
| US7220767 | Pharmaceutical formulations containing zolmitriptan |
28 Nov, 2020
(4 years ago)
| Expired |
| US5466699
(Pediatric)
| Indolyl compounds for treating migraine |
14 May, 2013
(11 years ago)
| Expired |
| US5466699 | Indolyl compounds for treating migraine |
14 Nov, 2012
(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 Zomig's drug page