Hydrocodone Bitartrate Patent Expiration

Hydrocodone Bitartrate was first introduced by Recro Gainesville Llc in its drug Zohydro Er on Oct 25, 2013. Other drugs containing Hydrocodone Bitartrate are Hysingla Er, Vantrela Er. 4 different companies have introduced drugs containing Hydrocodone Bitartrate.


Hydrocodone Bitartrate Patents

Given below is the list of patents protecting Hydrocodone Bitartrate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Zohydro Er US10092559 Abuse resistant pharmaceutical compositions Sep 12, 2034 Recro Gainesville
Zohydro Er US9132096 Abuse resistant pharmaceutical compositions Sep 12, 2034 Recro Gainesville
Zohydro Er US9452163 Abuse resistant pharmaceutical compositions Sep 12, 2034 Recro Gainesville
Zohydro Er US9486451 Abuse resistant pharmaceutical compositions Sep 12, 2034 Recro Gainesville
Zohydro Er US9713611 Abuse resistant pharmaceutical compositions Sep 12, 2034 Recro Gainesville
Zohydro Er US10028946 Treating pain in patients with hepatic impairment Jul 25, 2033 Recro Gainesville
Zohydro Er US10322120 Treating pain in patients with hepatic impairment Jul 25, 2033 Recro Gainesville
Zohydro Er US10456393 Treating pain in patients with hepatic impairment Jul 25, 2033 Recro Gainesville
Zohydro Er US10722511 Treating pain in patients with hepatic impairment Jul 25, 2033 Recro Gainesville
Zohydro Er US9265760 Treating pain in patients with hepatic impairment Jul 25, 2033 Recro Gainesville
Zohydro Er US9326982 Treating pain in patients with hepatic impairment Jul 25, 2033 Recro Gainesville
Zohydro Er US9333201 Treating pain in patients with hepatic impairment Jul 25, 2033 Recro Gainesville
Zohydro Er US9339499 Treating pain in patients with hepatic impairment Jul 25, 2033 Recro Gainesville
Zohydro Er US9421200 Treating pain in patients with hepatic impairment Jul 25, 2033 Recro Gainesville
Zohydro Er US9433619 Treating pain in patients with hepatic impairment Jul 25, 2033 Recro Gainesville
Zohydro Er US9610286 Treating pain in patients with hepatic impairment Jul 25, 2033 Recro Gainesville
Hysingla Er US8808740 Encased tamper resistant controlled release dosage forms Dec 21, 2031 Purdue Pharma Lp
Hysingla Er US9572779 Encased tamper resistant controlled release dosage forms Dec 21, 2031 Purdue Pharma Lp
Hysingla Er US9750703 Encased tamper resistant controlled release dosage forms Dec 21, 2031 Purdue Pharma Lp
Hysingla Er US9861584 Tamper resistant controlled release dosage forms Dec 21, 2031 Purdue Pharma Lp
Hysingla Er US9872837 Tamper resistant controlled release dosage forms Dec 21, 2031 Purdue Pharma Lp
Vantrela Er US8445018 Abuse resistant drug formulation Jul 31, 2029 Teva Branded Pharm
Vantrela Er US9216176 Abuse resistant drug formulation Sep 13, 2027 Teva Branded Pharm
Vantrela Er US9572803 Abuse resistant drug formulation Sep 13, 2027 Teva Branded Pharm
Hysingla Er US11304908 Tamper resistant dosage forms Aug 24, 2027 Purdue Pharma Lp
Hysingla Er US11304909 Tamper resistant dosage forms Aug 24, 2027 Purdue Pharma Lp
Hysingla Er US9084816 Tamper resistant dosage forms Aug 24, 2027 Purdue Pharma Lp
Hysingla Er US9095614 Tamper resistant dosage forms Aug 24, 2027 Purdue Pharma Lp
Hysingla Er US9095615 Tamper resistant dosage forms Aug 24, 2027 Purdue Pharma Lp
Hysingla Er US9486412 Tamper resistant dosage forms Aug 24, 2027 Purdue Pharma Lp
Hysingla Er US9486413 Tamper resistant dosage forms Aug 24, 2027 Purdue Pharma Lp
Hysingla Er US9492389 Tamper resistant dosage forms Aug 24, 2027 Purdue Pharma Lp
Hysingla Er US9492390 Tamper resistant dosage forms Aug 24, 2027 Purdue Pharma Lp
Hysingla Er US9492391 Tamper resistant dosage forms Aug 24, 2027 Purdue Pharma Lp
Hysingla Er US9545380 Tamper resistant dosage forms Aug 24, 2027 Purdue Pharma Lp
Hysingla Er US9763933 Tamper resistant dosage forms Aug 24, 2027 Purdue Pharma Lp
Hysingla Er US9770416 Tamper resistant dosage forms Aug 24, 2027 Purdue Pharma Lp
Hysingla Er US9775809 Tamper resistant dosage forms Aug 24, 2027 Purdue Pharma Lp
Hysingla Er US11844865 Abuse-proofed oral dosage form Feb 13, 2025 Purdue Pharma Lp
Hysingla Er US10130591 Abuse-proofed dosage form Nov 20, 2023

(Expired)

Purdue Pharma Lp
Hysingla Er US8309060 Abuse-proofed dosage form Nov 20, 2023

(Expired)

Purdue Pharma Lp
Hysingla Er US10369109 Abuse-proofed dosage form Jun 16, 2023

(Expired)

Purdue Pharma Lp
Hysingla Er US9675610 Abuse-proofed dosage form Jun 16, 2023

(Expired)

Purdue Pharma Lp
Hysingla Er US8529948 Pharmaceutical formulation containing gelling agent Aug 06, 2022

(Expired)

Purdue Pharma Lp
Hysingla Er US6733783 Controlled release hydrocodone formulations Oct 30, 2021

(Expired)

Purdue Pharma Lp
Hysingla Er US8361499 Controlled release hydrocodone formulations Oct 30, 2021

(Expired)

Purdue Pharma Lp
Hysingla Er US8551520 Controlled release hydrocodone Oct 30, 2021

(Expired)

Purdue Pharma Lp
Hysingla Er US8647667 Controlled release hydrocodone formulations Oct 30, 2021

(Expired)

Purdue Pharma Lp
Hysingla Er US9023401 Controlled release hydrocodone formulations Oct 30, 2020

(Expired)

Purdue Pharma Lp
Hysingla Er US9056052 Controlled release hydrocodone formulations Oct 30, 2020

(Expired)

Purdue Pharma Lp
Hysingla Er US9060940 Controlled release hydrocodone Oct 30, 2020

(Expired)

Purdue Pharma Lp
Hysingla Er US9198863 Controlled release hydrocodone formulations Oct 30, 2020

(Expired)

Purdue Pharma Lp
Hysingla Er US9205056 Controlled release hydrocodone formulations Oct 30, 2020

(Expired)

Purdue Pharma Lp
Hysingla Er US9289391 Controlled release hydrocodone formulations Oct 30, 2020

(Expired)

Purdue Pharma Lp
Hysingla Er US9517236 Controlled release hydrocodone formulations Oct 30, 2020

(Expired)

Purdue Pharma Lp
Hysingla Er US9572804 Controlled release hydrocodone formulations Oct 30, 2020

(Expired)

Purdue Pharma Lp
Hysingla Er US9669023 Controlled release hydrocodone formulations Oct 30, 2020

(Expired)

Purdue Pharma Lp
Hysingla Er US9669024 Controlled release hydrocodone formulations Oct 30, 2020

(Expired)

Purdue Pharma Lp
Hysingla Er US9675611 Methods of providing analgesia Oct 30, 2020

(Expired)

Purdue Pharma Lp
Hysingla Er US9682077 Methods of providing analgesia Oct 30, 2020

(Expired)

Purdue Pharma Lp
Zohydro Er US6228398 Multiparticulate modified release composition Nov 01, 2019

(Expired)

Recro Gainesville
Zohydro Er US6902742 Multiparticulate modified release composition Nov 01, 2019

(Expired)

Recro Gainesville
Hysingla Er US6488963 Hot-melt extrudable pharmaceutical formulation Jun 24, 2017

(Expired)

Purdue Pharma Lp



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Hydrocodone Bitartrate's patents.

Given below is the list recent legal activities going on the following patents of Hydrocodone Bitartrate.

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed 01 Jul, 2024 US9486451
Maintenance Fee Reminder Mailed 20 May, 2024 US9452163
Maintenance Fee Reminder Mailed 29 Apr, 2024 US9433619
Maintenance Fee Reminder Mailed 15 Apr, 2024 US9421200
Maintenance Fee Reminder Mailed 18 Mar, 2024 US10722511
Expire Patent 29 Jan, 2024 US9216176
Expire Patent 04 Dec, 2023 US10456393
Maintenance Fee Reminder Mailed 14 Aug, 2023 US9216176
Expire Patent 24 Jul, 2023 US10322120
Maintenance Fee Reminder Mailed 19 Jun, 2023 US10456393


Hydrocodone Bitartrate's Family Patents

Family Patents

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Hydrocodone Bitartrate Generics

Several generic applications have been filed for Hydrocodone Bitartrate.

Given below is the list of companies who have filed for Hydrocodone Bitartrate generic.


1. ALVOGEN

Alvogen Inc has filed for 10 different strengths of generic version for Hydrocodone Bitartrate. Given below are the details of the strengths of this generic introduced by Alvogen.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG tablet, extended release Prescription ORAL AB Mar 1, 2021
10MG

(reference standard)

capsule, extended release Prescription ORAL N/A Jan 21, 2020
15MG capsule, extended release Prescription ORAL N/A Jan 21, 2020
30MG tablet, extended release Prescription ORAL AB Mar 1, 2021
40MG tablet, extended release Prescription ORAL AB Mar 1, 2021
50MG capsule, extended release Prescription ORAL N/A Jan 21, 2020
60MG tablet, extended release Prescription ORAL AB Mar 1, 2021
80MG tablet, extended release Prescription ORAL AB Mar 1, 2021
100MG tablet, extended release Prescription ORAL AB Mar 1, 2021
120MG tablet, extended release Prescription ORAL AB Mar 1, 2021