Viewing data from:

NATESTO

NDA

TESTOSTERONE | N205488 | ACERUS PHARMACEUTICALS CORP

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

11090312

Mar. 17, 2034

11744838

Mar. 17, 2034

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

290 trials from ClinicalTrials.gov — 9 recruiting, 2 active, 223 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Testosterone in Bariatric Patients NCT03721497	Phase 4	Active	Esbjerg Hospital - University Hospital of Southern Denmark	64	2020-12-17 → 2025-12
Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease NCT00080756	Phase 2	Active	City of Hope Medical Center	11	2004-03-11 → 2024-10-15
A Dose Ranging Study to Examine TDS-Testosterone 5%NCT01894308	Phase 2	Not Yet Recruiting	Transdermal Delivery Solutions Corp	48	2026-06 → 2027-02
Product Transference Study of Testagen™ TDS®-Testosterone NCT02733133	Phase 2	Not Yet Recruiting	Transdermal Delivery Solutions Corp	96	2027-01-05 → 2027-12
Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression NCT04363164	Phase 2	Recruiting	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	150	2020-08-19 → 2027-07
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer NCT00588185	N/A	Recruiting	Memorial Sloan Kettering Cancer Center	300	2003-02 → 2027-02
TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis NCT03910738	Phase 2	Recruiting	University Hospital, Strasbourg, France	40	2019-10-29 → 2027-12
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency NCT04301765	Phase 2	Recruiting	Seattle Institute for Biomedical and Clinical Research	230	2021-01-12 → 2026-11-01
Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone NCT04049331	Phase 2	Recruiting	Seattle Institute for Biomedical and Clinical Research	240	2021-03-22 → 2027-01-30
Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism NCT03851627	Phase 4	Recruiting	Alexandra Kautzky-Willer	32	2022-01-25 → 2028-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$41.33

per gm

Lowest NADAC/Unit

$41.33

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
42667551101NATESTO NASAL 5.5 MG/0.122 GM	$41.33	GM	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$181.73

Highest Price

$181.73

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
42667-5511-01NATESTO	$181.73	FSS	Acerus Pharmaeutical Corporation	05/14/2026

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

Medicare Part D Spending

CMS annual spending data for Natesto (2024)

Total Spending

$490K

Total Claims

634

Beneficiaries

160

Avg Cost/Unit

$38.41

Spending Trend

$107K(2020)→$446K(2021)→$616K(2022)→$587K(2023)→$490K(2024)

YoY Change:-5.9%

5yr CAGR:+0.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain13 active DMFs12 inactive

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

PHARMACIA AND UPJOHN SUB PFIZER INCTESTOSTERONE, USP

DMF 31901978

ASPEN OSS BVTESTOSTERONE

DMF 118261996

BAYER AGTESTOSTERONE

DMF 150772000

BAYER AGTESTOSTERONE UNDECANOATE 750 MG I.M.

DMF 168092003

DR REDDYS LABORATORIES LTDTESTOSTERONE

DMF 236712010

SUN PHARMACEUTICAL INDUSTRIES LTDTESTOSTERONE USP

DMF 274472013

SYMBIOTEC PHARMALAB PRIVATE LTDTESTOSTERONE USP (MICRONIZED)

DMF 298692015

LUPIN LTDTESTOSTERONE USP

DMF 303772016

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDTESTOSTERONE CYPIONATE NON- STERILE, BULK DRUG SUBSTANCE

DMF 307412016

CURIA SPAIN SAUTESTOSTERONE MICRONIZED

DMF 328172018

HUBEI GOTO BIOTECHNOLOGY CO LTDTESTOSTERONE

DMF 331182018

HUBEI ZHUXI HUMANWELL PHARMACEUTICAL CO LTDTESTOSTERONE

DMF 370742022

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDTESTOSTERONE TRIDECANOATE

DMF 378902023

F.X. GASSNER, COLORADO STATE UNIVERSITYInactiveTESTOSTERONE & DIETHYLSTILBESTROL-CATTLE FEED MIXED W/INGREDS--SAFETY?

DMF 2741940

DIOSYNTH BVInactiveTESTOSTERONE

DMF 39741980

ROUSSELL UCLAFInactiveTESTOSTERONE (DIOSYNTH BV)

DMF 45121982

SCHERING AGInactiveTESTOSTERONE

DMF 46951982

MEDISORB TECHNOLOGIES INTERNATIONAL LTD PARTNERSHIPInactiveTESTOSTERONE INJECTABLE MICROSPHERES

DMF 75021988

SIGMA F AND D DIV LTDInactiveTESTOSTERONE

DMF 99311992

ARDANA BIOSCIENCE LTDInactiveTESTOSTERONE CREAM 1% (ARD-0403)

DMF 193492006

CIPLA LTDInactiveTESTOSTERONE USP

DMF 215462008

BIOVET JOINT STOCK COInactiveTESTOSTERONE

DMF 231572009

PRODUCTOS QUIMICOS NATURALES SA DE CV PROQUINAInactiveTESTOSTERONE L-2

DMF 243102010

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDInactiveTESTOSTERONE PROPIONATE NON-STERILE BULK DRUG SUBSTANCE

DMF 256062011

INDO PHYTO CHEMICALS PRIVATE LTDInactiveTESTOSTERONE USP

DMF 264302012

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jul 15, 2025	SUPPL -5	View Letter (PDF)
Oct 27, 2016	SUPPL -2	View Letter (PDF)
May 13, 2015	SUPPL -1	View Letter (PDF)
Jun 2, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5.5MG/0.122GM ACTUATION

RLD

2 patents0 exclusivities▴

GEL, METERED;NASAL | Approved: May 28, 2014

Patents (2) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11090312	Mar 17, 2034	—	—	—		—
11744838	Mar 17, 2034	—	—	—		—