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  2. ›drugs
  3. ›PHENYLEPHRINE HYDROCHLORIDE
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PHENYLEPHRINE HYDROCHLORIDE

Marketedupdated 3mo ago
by Caplin Steriles Ltd
Approved
community read0 votes

🐶 often sniffed alongside

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all catalysts(1)

approval · 1
Apr 3, 2026
approval
5mo ago
PHENYLEPHRINE HYDROCHLORIDE — FDA approval
PHENYLEPHRINE HYDROCHLORIDE
→

Patent cliff

source: FDA Orange Book
first barrier falls
Jul 15, 2031
~4.9 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (12)

  • Aug 8, 2044formulationUS 12564561
  • Sep 26, 2036formulationUS 11213480
  • Sep 26, 2036formulationUS 11213480
  • Sep 26, 2036formulationUS 12257342
  • Sep 26, 2036formulationUS 12257342
  • Aug 5, 2036formulationUS 11471400
  • Aug 5, 2036formulationUS 11471400
  • Nov 14, 2033method-of-use (U-1594)US 8859623
  • Nov 14, 2033method-of-use (U-1594)US 8859623
  • Jul 15, 2031method-of-use (U-3685)US 108399604.9y
  • Jul 15, 2031method-of-use (U-3685)US 113983064.9y
  • Jul 15, 2031method-of-use (U-3685)US 118394874.9y

FDA exclusivities (1)

  • May 5, 2026NPNP

News(0)

no news has mentioned this drug yet

brand
PHENYLEPHRINE HYDROCHLORIDE
generic
PHENYLEPHRINE HYDROCHLORIDE
indication
Mydriasis
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 38m ago
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