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MYTESI

NDA

CROFELEMER | N202292 | NAPO PHARMACEUTICALS INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

2031

2032

Today

8962680

Oct. 31, 2031

9585868

Oct. 31, 2031

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

11 trials from ClinicalTrials.gov, 11 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib NCT03094052	Phase 2	Completed	University of California, San Francisco	11	2018-10-09 → 2022-10-31
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients NCT00002408	Phase 3	Completed	Shaman Pharmaceuticals	300	—
A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome NCT00101725	Phase 2	Completed	Bausch Health Americas, Inc.	245	2004-12 → 2005-11
Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients NCT02910219	Phase 2	Completed	Sandra Swain	53	2017-01-31 → 2020-11-23
Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious Diarrhea NCT04192487	Phase 4	Completed	Napo Pharmaceuticals, Inc.	17	2019-10-22 → 2021-08-31
Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea NCT01374490	Phase 3	Completed	Bausch Health Americas, Inc.	250	2011-06-07 → 2012-10-31
Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients NCT03898856	Phase 4	Completed	The University of Texas Health Science Center, Houston	93	2019-04-01 → 2025-01-30
Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects With Acquired Immunodeficiency Syndrome (AIDS)NCT00002186	N/A	Completed	Shaman Pharmaceuticals	400	—
SP-303T Applied to the Skin of Patients With Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success With Acyclovir NCT00002310	N/A	Completed	Shaman Pharmaceuticals	—	—
Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea NCT00547898	Phase 3	Completed	Bausch Health Americas, Inc.	374	2007-10 → 2011-07-11

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

VA Federal Supply Schedule

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

Lowest Price

$1782.30

Highest Price

$1782.30

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
70564-0802-60MYTESI ORAL TABLET DELAYED RELEASE 125MG	$1782.30	FSS	Napo Pharmaceuticals, Inc.	07/31/2028

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

Medicare Part D Spending

CMS annual spending data for Mytesi (2024)

Total Spending

$8.0M

Total Claims

2,591

Beneficiaries

376

Avg Cost/Unit

$41.50

Spending Trend

$3.4M(2019)→$8.4M(2020)→$9.0M(2021)→$7.4M(2022)→$7.4M(2023)→$8.0M(2024)

YoY Change:-0.5%

5yr CAGR:+10.2%

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Apr 4, 2024	SUPPL -9	View Letter (PDF)
Nov 17, 2020	SUPPL -7	View Letter (PDF)
Mar 12, 2018	SUPPL -6	View Letter (PDF)
Jan 2, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 125MG

RLD

2 patents0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: Dec 31, 2012

Patents (2) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8962680	Oct 31, 2031	—	—	—		—
9585868	Oct 31, 2031	—	—	—		—