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Headache disorder — Treatment Landscape & Competitive Intelligence

Headache disorder (disease) competitive landscape: 10 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

10 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating Headache disorder, deduplicated by molecule. See the full disease page for line-of-therapy detail.

DrugGenericSponsorClassTargetLine of therapyFirst approval
Renacidin CITRIC ACID Baxter Anti-coagulant 1982-01-01
Sudafed PE phenylephrine Generic (multiple manufacturers) Alpha-1 adrenergic agonist (decongestant/vasopressor) Alpha-1A adrenergic receptor, Alpha-1B adrenergic receptor, Alpha-1D adrenergic receptor 1976-01-01
Aleve naproxen Generic (originally Syntex) NSAID Aldo-keto reductase family 1 member C2, Aldo-keto reductase family 1 member C3, Prostaglandin G/H synthase 1 1976-01-01
Sudafed pseudoephedrine Generic (multiple manufacturers) Nasal decongestant (sympathomimetic) Alpha-1A adrenergic receptor, Alpha-2A adrenergic receptor, Beta-2 adrenergic receptor 1976-01-01
Lithobid lithium carbonate Generic (multiple manufacturers) Mood stabilizer Inositol-1(or 4)-monophosphatase 1, Glycogen synthase kinase-3 1970-04-06
Advil ibuprofen Generic (originally Boots Group) Nonsteroidal Anti-inflammatory Drug [EPC] Sodium-coupled monocarboxylate transporter 1, Acid-sensing ion channel 1, Aldo-keto reductase family 1 member C2 1969-01-15
Acetaminophen Paracetamol Polymedica acetaminophen Transient receptor potential cation channel subfamily V member 4 1968-01-01
Delsym dextromethorphan Generic (originally Roche) Antitussive (non-opioid) Taste receptor type 2 member 46, Solute carrier family 22 member 1, Cytochrome P450 2D6 1958-01-01
Mucinex guaifenesin Generic (multiple manufacturers) Expectorant [EPC] Vagal gastric reflex → increased respiratory secretions 1952-01-01
Phenergan Vc W/ Codeine PHENYLEPHRINE BITARTRATE ANI Pharmaceuticals Nonsteroidal Anti-inflammatory Drug [EPC] Alpha-1B adrenergic receptor 1952-01-01

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

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

Upcoming PDUFA dates (next 180 days)

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

Sponsor landscape

  1. Generic (multiple manufacturers) · 5 drugs in Headache disorder
  2. · 4 drugs in Headache disorder
  3. Baxter · 1 drug in Headache disorder
  4. Endo · 1 drug in Headache disorder
  5. Generic (originally Boots Group) · 1 drug in Headache disorder
  6. Generic (originally Roche) · 1 drug in Headache disorder
  7. Generic (originally Syntex) · 1 drug in Headache disorder
  8. Hikma · 1 drug in Headache disorder
  9. Polymedica · 1 drug in Headache disorder
  10. ANI Pharmaceuticals · 1 drug in Headache disorder

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Every new regulatory action, PDUFA date, or trial completion in Headache disorder:

Cite this brief

Drug Landscape (2026). Headache disorder — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/headache-disorder. Accessed 2026-06-10.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing