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DIFICID

NDA

FIDAXOMICIN | N201699 | CUBIST PHARMACEUTICALS LLC

1 strength4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Expiring < 1yr (1)Active (3)TodayPED (+6 mo)Exclusivity

2027

2028

Today

Jan. 31, 2028

Jan. 31, 2028

Sep. 4, 2027

Jan. 31, 2028

ODE-367

Jan. 24, 2027

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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
MERCK SHARP & DOHME LLC et al v. SUN PHARMACEUTICAL INDUSTRIES LTD. et al 2:2025cv01424 4 patentsANDA 220102fidaxomicin	D.N.J.	2025-02-24	Terminated 2025-05-12	—
MERCK SHARP & DOHME CORP. et al v. ACTAVIS LABORATORIES FL, INC. 2:2020cv00534 5 patentsANDA 208443fidaxomicin	D.N.J.	2020-01-16	Terminated 2020-02-13	—
MERCK SHARP & DOHME CORP. et al v. ACTAVIS LABORATORIES FL, INC. et al 2:2015cv06541 5 patentsANDA 208443fidaxomicin	D.N.J.	2015-08-31	Terminated 2021-11-01	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Cubist Pharmaceuticals, Inc FDA-2015-P-1595 · 5 docket documents Cubist Pharmaceuticals, Inc. filed this citizen petition on May 6, 2015, requesting that the FDA impose scientifically appropriate bioequivalence standards for abbreviated new drug applications and 505(b)(2) new drug applications referencing DIFICID (fidaxomicin) 200 mg film-coated tablets as the re	505(q)	2015-10-27	Partially Denied	Cubist Pharmaceuticals, Inc

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

Clinical Trials

22 trials from ClinicalTrials.gov, 14 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population NCT02254967	Phase 4	Completed	Astellas Pharma Europe Ltd.	364	2014-11-06 → 2016-05-05
A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)NCT02179658	Phase 3	Completed	Astellas Pharma Inc	210	2014-06-23 → 2016-09-08
A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)NCT02784002	Phase 2	Completed	Summit Therapeutics	27	2014-12 → 2016-08
Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)NCT01591863	Phase 2	Completed	Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	38	2012-06-15 → 2014-03-07
A Study to Assess the Effects of Multiple Doses of Fidaxomicin on a Single Dose of Rosuvastatin in Healthy Male Subjects NCT02083627	Phase 1	Completed	Astellas Pharma Europe B.V.	25	2013-02 → 2013-03
A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)NCT02218372	Phase 3	Completed	Astellas Pharma Europe B.V.	148	2015-01-09 → 2018-03-07
Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)NCT01691248	Phase 3	Completed	Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	611	2012-10-10 → 2015-04-16
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects NCT01813448	Phase 1	Completed	Astellas Pharma Global Development, Inc.	36	2013-02 → 2013-04
A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections NCT02692651	Phase 4	Completed	University of Michigan	144	2017-05-01 → 2021-06-23
Impact of Oral Antibiotic Treatment on C. Difficile NCT02057198	Phase 4	Completed	Duke University	33	2014-06-10 → 2017-06-27

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

$248.65

per ea

Lowest NADAC/Unit

$248.65

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
52015008001DIFICID 200 MG TABLET	$248.65	EA	Brand	$100.07	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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$3090.32

Highest Price

$4969.55

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
52015-0080-01DIFICID 200MG TAB	$4969.55	FSS	Merck Sharp & Dohme LLC	05/31/2030
52015-0080-01DIFICID 200MG TAB	$3090.32	Big4	Merck Sharp & Dohme LLC	05/31/2030

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

Medicare Part D Spending

CMS annual spending data for Dificid (2024)

Total Spending

$153.8M

Total Claims

34,589

Beneficiaries

26,020

Avg Cost/Unit

$245.75

Spending Trend

$44.5M(2019)→$47.4M(2020)→$68.0M(2021)→$103.1M(2022)→$127.2M(2023)→$153.8M(2024)

YoY Change:+0.4%

5yr CAGR:+4.3%

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

API Supply Chain4 active DMFs

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

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDFIDAXOMICIN CRYSTALLINE

DMF 288032014

NORTH CHINA PHARMACEUTICAL HUASHENG CO LTDFIDAXOMICIN

DMF 293742015

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDFIDAXOMICIN

DMF 388152023

HUBEI HONCH PHARMACEUTICAL CO LTDFIDAXOMICIN

DMF 421622026

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jun 1, 2020	SUPPL -13	View Letter (PDF)
Jan 27, 2020	SUPPL -12	View Letter (PDF)
Apr 8, 2019	SUPPL -11	View Letter (PDF)
Mar 18, 2019	SUPPL -10	View Letter (PDF)
Feb 26, 2015	SUPPL -9	View Letter (PDF)
Apr 9, 2013	SUPPL -4	View Letter (PDF)
May 31, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG

RLDAB

4 patents1 exclusivity▴

TABLET;ORAL | Approved: May 27, 2011

Patents (4) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7378508	Jul 31, 2027PED: Jan 31, 2028	PED	Yes	Yes	—	—
7863249	Jul 31, 2027PED: Jan 31, 2028	PED	Yes	Yes	—	—
7906489	Mar 4, 2027PED: Sep 4, 2027	PED	—	—		—
8859510	Jul 31, 2027PED: Jan 31, 2028	PED	—	—		—

Exclusivities (1)

Code	Date	Status
ODE-367	Jan 24, 2027	< 1 year