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BIORPHEN

NDA

PHENYLEPHRINE HYDROCHLORIDE | N212909 | DR REDDYS LABORATORIES SA

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Apotex Corp. FDA-2026-P-6257 · 8 docket documents Apotex Corp. filed a suitability petition requesting that the FDA determine whether orlistat is a suitable candidate for abbreviated new drug application (ANDA) approval as a generic version of Xenical.	Suitability	2026-06-02	DeniedDecision letter not yet read	Apotex Corp.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

164 trials from ClinicalTrials.gov — 8 recruiting, 1 active, 107 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System NCT03620942	N/A	Active	KK Women's and Children's Hospital	173	2018-11-07 → 2027-12-31
Autoimmune Basis for Postural Tachycardia Syndrome NCT02725060	N/A	By Invitation	Vanderbilt University Medical Center	58	2016-02 → 2026-12
Role of Sympathetic Overactivity and Angiotensin II in PTSD and CV NCT02560805	Phase 2	Recruiting	Emory University	134	2015-10 → 2027-03-30
Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV NCT02323399	Phase 4	Recruiting	West-Ward Pharmaceutical	100	2015-02 → 2024-12
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
Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury NCT01731444	Phase 1	Recruiting	University of Manitoba	24	2014-12-01 → 2028-12-31
Vasoactive Drugs in Intensive Care Unit NCT02118467	Phase 4	Recruiting	University of Chicago	836	2014-05-15 → 2026-12-01
Effects of Ephedrine, Phenylephrine, Norepinephrine and Vasopressin on Contractility of Human Myometrium and Umbilical Vessels: An In-vitro Study NCT04053478	N/A	Recruiting	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	144	2019-07-08 → 2026-12
Targeted Blood-pressure Management and Acute Kidney Injury After Coronary Artery Bypass Surgery NCT03629418	N/A	Recruiting	Peking University First Hospital	612	2018-08-14 → 2026-07
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; data refreshed each weekday and may lag the registry.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$2.85

Highest Price

$29.65

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
43598-0172-15PHENYLEPHRINE HCL 0.1MG/ML INJ	$29.65	FSS	Dr. Reddys Laboratories	09/14/2026
43598-0172-25BIORPHEN 100MCG/ML INJ	$2.85	FSS	Dr. Reddys Laboratories	09/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part B Spending

CMS physician-administered drug spending for Biorphen (2024)

Total Spending

$9K

Total Claims

1,849

Beneficiaries

1,827

ASP Price

$0.17

HCPCS: J2372 — Injection, phenylephrine hydrochloride (biorphen), 20 micrograms

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain10 active DMFs5 inactive

10 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

SHILPA PHARMA LIFESCIENCES LTDPHENYLEPHRINE HYDROCHLORIDE, USP

DMF 362362021

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 4, 2024	SUPPL -2	View Letter (PDF)
Mar 12, 2021	SUPPL -1	View Letter (PDF)
Oct 23, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.5MG/5ML (0.1MG/ML)

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Oct 21, 2019

No patent or exclusivity listings for this strength.

#002 — 10MG/ML (10MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Mar 11, 2021