Hydrocodone ER — Competitive Intelligence Brief

Hydrocodone ER (Hydrocodone ER) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid analgesic. Area: Pain Management.

phase 3 Opioid analgesic Mu-opioid receptor Pain Management Small molecule

Target snapshot

Hydrocodone ER (Hydrocodone ER) — Teva Branded Pharmaceutical Products R&D, Inc.. Hydrocodone is an opioid agonist that binds to mu-opioid receptors in the central nervous system to reduce pain perception and provide analgesia.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Hydrocodone ER TARGET	Hydrocodone ER	Teva Branded Pharmaceutical Products R&D, Inc.	phase 3	Opioid analgesic	Mu-opioid receptor
BENZHYDROCODONE	BENZHYDROCODONE		marketed	Opioid analgesic combination; full mu-opioid agonist with non-opioid analgesic	Mu-opioid receptors (primary); delta and kappa opioid receptors (secondary); central nervous system pain pathways	2018-01-01
Dilaudid-Hp	Hydromorphone Hydrochloride	Fresenius Kabi	marketed	Opioid agonist	Mu-opioid receptor	1984-01-01
Dilaudid-Hp	HYDROMORPHONE	Fresenius Kabi	marketed	Opioid Agonist	mu-opioid receptor	1984-01-01
Subutex	BUPRENORPHINE	Purdue Pharma Lp	marketed	Partial Opioid Agonist	mu-opioid receptor, kappa-opioid receptor	1981-01-01
Subutex	Buprenorphine Hydrochloride	Indivior	marketed	partial opioid agonist	mu-opioid receptor, kappa-opioid receptor	1981-01-01
Levo-Dromoran	LEVORPHANOL	Bausch Health	marketed	Opioid Agonist	mu-opioid receptor	1953-01-01

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

• 2026-07-31 — Subutex · 8236755 · Formulation · US
• 2027-01-10 — Subutex · 8236292 · Formulation · US
• 2027-07-23 — Subutex · 8147866 · Formulation · US
• 2027-07-23 — Subutex · 9655843 · Formulation · US
• 2031-06-06 — Subutex · 9782402 · Formulation · US
• 2031-06-06 — Subutex · 9827241 · Formulation · US
• 2031-06-06 — Subutex · 10198218 · Method of Use · US
• 2031-06-06 — Subutex · 10592168 · Method of Use · US
• 2031-06-06 — Subutex · 9498432 · Formulation · US
• 2031-06-06 — Subutex · 9272044 · Method of Use · US
• 2031-06-25 — Subutex · 10558394 · Formulation · US
• 2031-09-05 — Subutex · 8975270 · Formulation · US
• 2032-01-06 — Subutex · 8921387 · Formulation · US
• 2032-07-26 — Subutex · 11135215 · Formulation · US
• 2032-07-26 — Subutex · 12318379 · Formulation · US
• 2032-07-26 — Subutex · 12161640 · Formulation · US
• 2032-07-26 — Subutex · 11110084 · Formulation · US
• 2032-07-26 — Subutex · 10912772 · Method of Use · US
• 2032-07-26 — Subutex · 9937164 · Formulation · US
• 2032-12-21 — Subutex · 9901539 · Method of Use · US
• 2035-11-06 — Subutex · 11000520 · Method of Use · US
• 2035-11-06 — Subutex · 11839611 · Method of Use · US
• 2038-06-22 — Subutex · 10646484 · Method of Use · US

Sponsor landscape (Opioid analgesic class)

1. Alza Corporation, DE, USA · 3 drugs in this class
2. Labopharm Inc. · 3 drugs in this class
3. University of Rochester · 3 drugs in this class
4. Purdue Pharma LP · 3 drugs in this class
5. Institute of Child Health · 2 drugs in this class
6. London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · 2 drugs in this class
7. Fujian Cancer Hospital · 2 drugs in this class
8. Children's Hospital of Fudan University · 2 drugs in this class
9. AdventHealth · 2 drugs in this class
10. Danish University of Pharmaceutical Sciences · 2 drugs in this class