Viewing data from:

ARTHROTEC

NDA

DICLOFENAC SODIUM; MISOPROSTOL | N020607 | PFIZER 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 6 NDCs (3 brand, 3 generic)

Highest NADAC/Unit

$8.55

per ea

Lowest NADAC/Unit

$0.7750

per ea

Brand NDCs

Generic NDCs

Avg Brand: $8.52

Avg Generic: $0.8666

90% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00025141160ARTHROTEC 50 MG-200 MCG TAB	$8.55	EA	Brand	$0.7750	2026-04-22
00025141190ARTHROTEC 50 MG-200 MCG TAB	$8.55	EA	Brand	$0.7750	2026-04-22
00025142160ARTHROTEC 75 MG-200 MCG TAB	$8.47	EA	Brand	$1.05	2026-10-21
59762002901DICLOFENAC-MISOPROSTOL DR 75-0.2 MG TABLET	$1.05	EA	Generic	—	2026-10-21
59762002801DICLOFENAC-MISOPROSTOL DR 50-0.2 MG TABLET	$0.7750	EA	Generic	—	2026-10-21
59762002802DICLOFENAC-MISOPROSTOL DR 50-0.2 MG TABLET	$0.7750	EA	Generic	—	2026-10-21

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

VA Federal Supply Schedule

Government-negotiated contract prices | 12 NDCs (6 FSS, 6 Big4)

Lowest Price

$15.49

Highest Price

$783.32

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59762-0028-01DICLOFENAC NA 50MG/MISOPROSTOL 200MCG TAB	$21.43	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-0028-01DICLOFENAC NA 50MG/MISOPROSTOL 200MCG TAB	$124.49	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-0028-02DICLOFENAC NA 50MG/MISOPROSTOL 200MCG TAB	$35.43	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-0028-02DICLOFENAC NA 50MG/MISOPROSTOL 200MCG TAB	$186.71	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-0029-01DICLOFENAC NA 75MG/MISOPROSTOL 200MCG TAB	$15.49	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-0029-01DICLOFENAC NA 75MG/MISOPROSTOL 200MCG TAB	$99.60	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027

Showing 6 of 12 NDCs.

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

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Nov 22, 2024	SUPPL -43	View Letter (PDF)
Dec 23, 2022	SUPPL -41	View Letter (PDF)
Aug 29, 2022	SUPPL -40	View Letter (PDF)
Aug 5, 2021	SUPPL -39	View Letter (PDF)
Apr 29, 2021	SUPPL -38	View Letter (PDF)
Sep 25, 2020	SUPPL -36	View Letter (PDF)
Jul 29, 2020	SUPPL -33	View Letter (PDF)
May 12, 2016	SUPPL -31	View Letter (PDF)
Apr 3, 2015	SUPPL -21	View Letter (PDF)
Sep 5, 2014	SUPPL -28	View Letter (PDF)
Mar 8, 2013	SUPPL -25	View Letter (PDF)
Dec 22, 2010	SUPPL -16	View Letter (PDF)
Nov 10, 2009	SUPPL -13	View Letter (PDF)
Feb 27, 2009	SUPPL -14	View Letter (PDF)
Aug 27, 2007	SUPPL -10	View Letter (PDF)
Jan 30, 2006	SUPPL -9	View Letter (PDF)
Jul 15, 2005	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG;0.2MG

RLDAB

0 patents0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: Dec 24, 1997

No patent or exclusivity listings for this strength.

#002 — 75MG;0.2MG

RLDAB

0 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Dec 24, 1997