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Amneal Drug Patent Portfolio

Amneal owns 6 orange book drugs protected by 35 US patents with Tigecycline having the least patent protection, holding only 2 patents. And Ongentys with maximum patent protection, holding 10 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
US10532049 Parenteral unit dosage form of dihydroergotamine 26 Feb, 2039
Active
US11304942 Parenteral unit dosage form of dihydroergotamine 26 Feb, 2039
Active
US11819501 Parenteral unit dosage form of dihydroergotamine 26 Feb, 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
US12233166 Extended release compositions comprising pyridostigmine 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
US12129247 Administration regime for nitrocatechols 11 Jan, 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


Given below is the list of recent legal activities going on the following drug patents of Amneal.

Activity Date Patent Number
Patent litigations
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
Patent litigations
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 drugs have patent protection in a total of 32 countries. It's US patent count contributes only to 19.3% of its total global patent coverage. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree.

Family Patents



Amneal Drug List

Given below is the complete list of Amneal's drugs and the patents protecting them.


1. Brekiya (autoinjector)

Brekiya (autoinjector) 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
US10532049 Parenteral unit dosage form of dihydroergotamine 26 Feb, 2039
(13 years from now)
Active
US11304942 Parenteral unit dosage form of dihydroergotamine 26 Feb, 2039
(13 years from now)
Active
US11819501 Parenteral unit dosage form of dihydroergotamine 26 Feb, 2039
(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 Brekiya (autoinjector)'s drug page


2. 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


3. Ongentys

Ongentys is protected by 10 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
(9 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
US12129247 Administration regime for nitrocatechols 11 Jan, 2032
(6 years from now)
Active
US10071085 Pharmaceutical formulations comprising nitrocatechol derivatives and methods of making thereof 31 Mar, 2030
(4 years from now)
Active
US10583130 Pharmaceutical formulations compromising nitrocatechol derivatives and methods of making thereof 31 Mar, 2030
(4 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
(3 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
(1 year, 10 months from now)
Active
US9550759 Nitrocatechol derivatives as COMT inhibitors 26 Jul, 2026
(1 year, 22 days 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


4. Pyridostigmine Bromide

Pyridostigmine Bromide 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
US10881617 Extended release compositions comprising pyridostigmine 18 Jun, 2038
(12 years from now)
Active
US10925833 Extended release compositions comprising pyridostigmine 18 Jun, 2038
(12 years from now)
Active
US10987311 Extended release compositions comprising pyridostigmine 18 Jun, 2038
(12 years from now)
Active
US11229606 Extended release compositions comprising pyridostigmine 18 Jun, 2038
(12 years from now)
Active
US11478425 Extended release compositions comprising pyridostigmine 18 Jun, 2038
(12 years from now)
Active
US11666536 Extended release compositions comprising pyridostigmine 18 Jun, 2038
(12 years from now)
Active
US11911515 Extended release compositions comprising pyridostigmine 18 Jun, 2038
(12 years from now)
Active
US12042559 Gastroretentive dosage forms for sustained drug delivery 18 Jun, 2038
(12 years from now)
Active
US12233166 Extended release compositions comprising pyridostigmine 18 Jun, 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 Pyridostigmine Bromide's drug page


5. 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
(7 years from now)
Active
US9855355 Method and device for plasma-treating hollow bodies 07 Apr, 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 Tigecycline's drug page


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Find the opportunity to file Oppositions
View List

6. 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
(4 years ago)
Expired
US7220767
(Pediatric)
Pharmaceutical formulations containing zolmitriptan 28 May, 2021
(4 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
(12 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


Amneal News

Federal Trade Commission Pursues Actions to Remove Patents from Drug Device Administration in ...

27 May, 2025

Teva Unsuccessful in Inhaler Patent Lawsuit Against Amneal, Required to Modify Orange Book Entry

12 Jun, 2024

During FTC crackdown, judge finds Teva inhaler patents not listed correctly in FDA Orange Book

12 Jun, 2024

FTC considers Teva's inhaler lawsuit against Amneal in the midst of broad patent enforcement efforts

25 Mar, 2024

See More