Fentanyl Buccal Tablet — Competitive Intelligence Brief

Fentanyl Buccal Tablet (Fentanyl Buccal Tablet) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid analgesic. Area: Oncology.

phase 3 Opioid analgesic Mu opioid receptor (μ-OR) Oncology Small molecule

Target snapshot

Fentanyl Buccal Tablet (Fentanyl Buccal Tablet) — M.D. Anderson Cancer Center. Fentanyl buccal tablet delivers the opioid fentanyl through the buccal mucosa to provide rapid analgesia by binding to mu opioid receptors in the central nervous system.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Fentanyl Buccal Tablet TARGET	Fentanyl Buccal Tablet	M.D. Anderson Cancer Center	phase 3	Opioid analgesic	Mu opioid receptor (μ-OR)
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
Duragesic	fentanyl	Johnson & Johnson (Janssen Pharmaceutica)	marketed	Synthetic opioid analgesic	D(4) dopamine receptor, Solute carrier family 22 member 1, D(2) dopamine receptor	1968-01-01
Codeine	codeine phosphate	Generic (multiple manufacturers)	marketed	Opioid analgesic, Antitussive	Delta-type opioid receptor, Kappa-type opioid receptor, Mu-type opioid receptor	1950-01-01
MEPERIDINE	MEPERIDINE		marketed	opioid analgesic	mu-opioid receptor	1942-01-01
MS Contin	morphine sulfate	Generic (multiple manufacturers)	marketed	Opioid analgesic	Solute carrier family 22 member 1, Delta-type opioid receptor, Kappa-type opioid receptor	1941-01-01
Oxycodone/Naloxone Prolonged Release	Oxycodone/Naloxone Prolonged Release	Grünenthal GmbH	marketed	Opioid analgesic with abuse-deterrent formulation	Mu-opioid receptor (oxycodone); opioid receptors (naloxone antagonism)

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)

• 2027-01-25 — Duragesic · 10610523 · Formulation · US
• 2027-01-25 — Duragesic · 8835460 · Formulation · US
• 2027-01-25 — Duragesic · 9642797 · Formulation · US
• 2027-01-25 — Duragesic · 9289387 · Formulation · US
• 2027-01-25 — Duragesic · 10016403 · Formulation · US
• 2027-01-25 — Duragesic · 9241935 · Formulation · US
• 2027-01-25 — Duragesic · 9642844 · Formulation · US
• 2027-01-25 — Duragesic · 8835459 · Formulation · US
• 2028-08-12 — MS Contin · 10314788 · Formulation · US
• 2028-08-12 — MS Contin · 7955619 · Formulation · US
• 2030-04-27 — Duragesic · 8486973 · Method of Use · US
• 2030-04-27 — Duragesic · 8486972 · Formulation · US
• 2033-07-01 — MS Contin · 9044402 · Formulation · US
• 2033-07-01 — MS Contin · 9549899 · Formulation · US
• 2034-03-12 — MS Contin · 9248229 · Formulation · US
• 2034-03-12 — MS Contin · 9192608 · Method of Use · US
• 2034-03-12 — MS Contin · 9072781 · Formulation · 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