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SUS-PHRINE SULFITE FREE

NDA

EPINEPHRINE | N007942 | FOREST LABORATORIES INC

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

16 trials from ClinicalTrials.gov — 12 recruiting, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials NCT05492578	Phase 2/3	By Invitation	Sanofi	1,663	2022-08-22 → 2029-01-22
Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial NCT04429607	Phase 2	By Invitation	Northwestern University	18	2025-10-23 → 2026-12
HAMSTRING TIGHTNESS AND LUMBAR LORDOSIS ANGLE ACROSS FUNCTIONAL SITTING POSTURES NCT07682142	—	Not Yet Recruiting	Cairo University	110	2026-08-01 → 2026-12-01
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)NCT06780085	Phase 2	Recruiting	Merck Sharp & Dohme LLC	96	2025-05-13 → 2032-03-12
Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism NCT06246357	Phase 2	Recruiting	National Cancer Institute (NCI)	80	2024-09-23 → 2028-04-01
Study of Endocrine-Related Conditions and Physiology NCT03867448	—	Recruiting	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1,000	2019-03-27 → 2036-01-01
Childhood Traumas in Obese Women: Association With Deregulation of the Glucocorticoid Axis and Inflammatory State.NCT05237440	N/A	Recruiting	University Hospital, Limoges	102	2022-04-13 → 2027-05-13
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms NCT01005654	—	Recruiting	National Cancer Institute (NCI)	2,415	2009-10-07
Natural History Study of Patients With Excess Androgen NCT00250159	—	Recruiting	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	3,000	2006-01-02
An Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia NCT06712823	Phase 2	Recruiting	Crinetics Pharmaceuticals Inc.	200	2025-02-25 → 2029-08

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

Medicare Part D Spending

CMS annual spending data for Epipen 2-Pak (2023)

Total Spending

$900K

Total Claims

1,438

Beneficiaries

1,172

Avg Cost/Unit

$295.70

Spending Trend

$9.2M(2019)→$155K(2019)→$6.8M(2020)→$40K(2020)→$1.7M(2021)→$18K(2021)→$27K(2022)→$1.2M(2022)→$900K(2023)→$28K(2023)

YoY Change:-2.2%

5yr CAGR:-0.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain11 active DMFs2 inactive

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

WOCKHARDT LTDEPINEPHRINE USP

DMF 212132007

CAMBREX PROFARMACO MILANO SRLEPINEPHRINE

DMF 259892012

SUN PHARMACEUTICAL INDUSTRIES LTDEPINEPHRINE USP

DMF 286172014

MATRIX PHARMACORP PRIVATE LTDEPINEPHRINE USP

DMF 287492014

TRANSO PHARM HANDELS GMBHEPINEPHRINE TARTRATE/ADRENALINE TARTRATE

DMF 309962016

AMPHASTAR NANJING PHARMACEUTICALS INCEPINEPHRINE USP

DMF 330362018

GLAND PHARMA LTDEPINEPHRINE

DMF 353842020

PHLOW CORPEPINEPHRINE USP

DMF 375812024

GLAND PHARMA LTDEPINEPHRINE (LOW EPIMER)

DMF 387332023

OLON SPAEPINEPHRINE

DMF 407962024

ZHEJIANG BOXIAO BIOPHARMACEUTICAL CO LTDEPINEPHRINE (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 431562025

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveEPINEPHRINE HYDROGENTARTRATE

DMF 57791984

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveEPINEPHRINE

DMF 58221985

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

Products (2)

Sort:

#001 — 5MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 1.5MG/AMP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 5, 1999