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PHENYLEPHRINE HYDROCHLORIDE

NDA

PHENYLEPHRINE HYDROCHLORIDE | N203510 | PARAGON BIOTECK INC

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)TodayIPRPTAB Challenge

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8859623

Nov. 14, 2033PGR

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
PGR2015-00011	8859623	PGR	Altaire Pharmaceuticals, Inc.	Final Written Decision	2015-05-11	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 1 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Comparison of Norepinehrine Versus Phenylepherine Infusion for Prevention of Post-spinal Hypotension NCT07662408	Phase 4	Recruiting	Sohag University	62	2026-05-22 → 2027-03-14
Effectiveness of Continuous Phenylephrine in Preventing Shivering After Spinal Anesthesia in Cesarean Section NCT07663149	N/A	Completed	Indonesia University	108	2026-04-07 → 2026-06-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain9 active DMFs5 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

DIVI'S LABOTATORIES LTDPHENYLEPHRINE HYDROCHLORIDE USP

DMF 169182003

CHENG FONG CHEMICAL CO LTDPHENYLEPHRINE HYDROCHLORIDE

DMF 180572005

SYN-TECH CHEM AND PHARM CO LTDPHENYLEPHRINE HYDROCHLORIDE USP

DMF 183192005

NOVUS FINE CHEMICALS LLCPHENYLEPHRINE HYDROCHLORIDE

DMF 188992005

SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHPHENYLEPHRINE HYDROCHLORIDE

DMF 230832009

TRANSO PHARM HANDELS GMBHPHENYLEPHRINE HYDROCHLORIDE

DMF 287542014

UNICHEM LABORATORIES LTDPHENYLEPHRINE HYDROCHLORIDE USP

DMF 324382018

ZHEJIANG BOXIAO BIOPHARMACEUTICAL CO LTDPHENYLEPHRINE HYDROCHLORIDE

DMF 397302024

AARTI PHARMALABS LTDPHENYLEPHRINE HYDROCHLORIDE

DMF 425892025

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactivePHENYLEPHRINE HYDROCHLORIDE

DMF 59121985

SHENZHEN ORIENTAL PHARMACEUTICAL CO LTDInactivePHENYLEPHRINE HYDROCHLORIDE (API)

DMF 187992005

CAMBREX CHARLES CITY INCInactivePHENYLEPHRINE HYDROCHLORIDE

DMF 195502006

SHENZHEN HAPPY PHARMACEUTICALS LTDInactivePHENYLEPHRINE HYDROCHLORIDE

DMF 216142008

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactivePHENYLEPHRINE HYDROCHLORIDE 150 MESH

DMF 230072009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Dec 9, 2022	SUPPL -5	View Letter (PDF)
Apr 20, 2020	SUPPL -2	View Letter (PDF)
Mar 22, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 2.5%

RLDAT

1 patent0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Mar 21, 2013

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8859623	Nov 14, 2033	—	—	—		—

#002 — 10%

RLDAT

1 patent0 exclusivities▾

SOLUTION/DROPS;OPHTHALMIC | Approved: Mar 21, 2013