Viewing data from:

CYTOTEC

NDA

MISOPROSTOL | N019268 | 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from The Tatia Oden French Memorial Foundation FDA-2017-P-2563 The Tatia Oden French Memorial Foundation filed this citizen petition on April 24, 2017, requesting that the FDA conduct a Sentinel query to assess the rates and severity of adverse reactions associated with the off-label use of misoprostol (marketed as Cytotec) for cervical ripening and labor induc	Other	2017-04-26	Open	The Tatia Oden French Memorial Foundation

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

Clinical Trials

2 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Hysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention NCT05789940	N/A	Recruiting	University Hospital, Montpellier	220	2023-09-18 → 2029-09-18
Period Pills for Menstrual Regulation: A New Reproductive Health Option NCT07671989	Phase 4	Recruiting	University of California, San Francisco	100	2026-06-22 → 2027-05-31

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

Medicare Part D Spending

CMS annual spending data for Cytotec (2023)

Total Spending

$33K

Total Claims

Beneficiaries

Avg Cost/Unit

$6.03

Spending Trend

$59K(2019)→$36K(2020)→$50K(2021)→$41K(2022)→$33K(2023)

YoY Change:+10.3%

5yr CAGR:+4.8%

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

API Supply Chain4 active DMFs10 inactive

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

EVERLIGHT CHEMICAL INDUSTRIAL CORPMISOPROSTOL

DMF 150172000

EVERLIGHT CHEMICAL INDUSTRIAL CORPMISOPROSTOL - HPMC 1% DISPERSION

DMF 170762003

PIRAMAL HEALTHCARE UK LTDMISOPROSTOL DISPERSION

DMF 211882007

YS LIFE SCIENCE CO LTDMISOPROSTOL HPMC 1% DISPERSION

DMF 230422009

PHARMATECH INTERNATIONAL INCInactiveMISOPROSTOL

DMF 127291997

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveMISOPROSTOL

DMF 143901999

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveMISOPROSTOL HPMC DISPERSION 1:100

DMF 143911999

EVERLIGHT CHEMICAL INDUSTRIAL CORPInactiveMISOPROSTOL

DMF 145001999

DAIICHI FINE CHEMICAL CO LTDInactiveMISOPROSTOL DRUG SUBSTANCE

DMF 150442000

DAIICHI FINE CHEMICAL CO LTDInactiveMISOPROSTOL HPMC DISPERSION

DMF 150682000

APOTEX PHARMACHEM INCInactiveMISOPROSTOL 4% DISPERSION ON HYDROXYPROPYL METHYLCELLULOSE (HPMC)

DMF 175672004

CHINOIN PHARMACEUTCIAL AND CHEMICAL WORKS CO LTDInactiveMISOPROSTOL DISPERSION, HPMC 1%

DMF 208472007

YONSUNG FINE CHEMICALS CO LTDInactiveMISOPROSTOL

DMF 230412009

CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTDInactiveMISOPROSTOL

DMF 232492009

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Mar 1, 2018	SUPPL -51	View Letter (PDF)
Dec 19, 2016	SUPPL -49	View Letter (PDF)
Nov 21, 2012	SUPPL -47	View Letter (PDF)
Nov 12, 2009	SUPPL -41	View Letter (PDF)
Aug 14, 2003	SUPPL -40	View Letter (PDF)
Aug 14, 2003	SUPPL -39	View Letter (PDF)
Apr 17, 2002	SUPPL -37	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.2MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 27, 1988

No patent or exclusivity listings for this strength.

#003 — 0.1MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 21, 1990