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

3 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from American College of OB-GYN (ACOG) FDA-2000-P-0244 · 4 docket documents The American College of Obstetricians and Gynecologists submitted this petition requesting that the FDA Commissioner withdraw a G.D. Searle warning letter issued on August 23, 2000 regarding misoprostol and rescind any pregnancy-related contraindications not supported by scientific evidence, arguing	Other	2017-10-10	Open	American College of OB-GYN (ACOG)
Citizen Petition from American College of Obstetricians and Gynecologists FDA-2000-P-1373 · 9 docket documents The American College of Obstetricians and Gynecologists filed this petition requesting that the FDA withdraw G.D. Searle's August 2000 warning letter regarding misoprostol and rescind contraindications for use of the drug in pregnancy that lack scientific support, arguing that the drug is safe and e	Other	2017-10-03	Partially Denied	American College of Obstetricians and Gynecologists
Citizen Petition from The Tatia Oden French Memorial Foundation FDA-2017-P-2563 · 6 docket documents 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

293 trials from ClinicalTrials.gov — 1 recruiting, 204 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Prevention of Recurrent Ulcer Bleeding in Patients With Idiopathic Gastroduodenal Ulcer NCT03675672	Phase 4	Recruiting	Chinese University of Hong Kong	154	2018-06-21 → 2027-03-31
Combined Vaginal Misoprostol and Perivascular Vasopressin NCT03815344	Phase 4	Completed	Antonios Likourezos	74	2017-04-26 → 2019-06-30
Effect of Adjunctive Misoprostol Treatment on Blood Loss at Vaginal Delivery NCT02411916	N/A	Completed	New York City Health and Hospitals Corporation	143	2012-03-30 → 2019-02-16
Introducing Mifepristone-Misoprostol for Menstrual Regulation in Public Sector Facilities in Bangladesh NCT01798017	Phase 4	Completed	Gynuity Health Projects	1,738	2012-11 → 2015-08
The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial NCT01931410	Phase 4	Completed	Istanbul Bakirkoy Maternity and Children Diseases Hospital	618	2013-06 → 2014-02
Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion NCT00129506	Phase 4	Completed	Wiebe, Ellen, M.D.	300	2005-05 → 2005-10
Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor NCT01428037	Phase 3	Completed	Regenex Pharmaceutical, China	225	2012-03 → 2013-01
The Use of Oxytocin, Carbetocin and Buccal Misoprostol in Patients Undergoing Elective Cesarean Section (CS)NCT02053922	Phase 3	Completed	Ain Shams University	270	2012-12 → 2013-08
Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births NCT01485562	N/A	Completed	Gynuity Health Projects	84	2012-05 → 2014-12
Combined Use of Oxytocin and Misoprostol Versus Oxytocin Infusion and Misoprostol Alone to Reduce Blood Loss at Cesarean Section NCT01571323	Phase 1/2	Completed	Qazvin University Of Medical Sciences	150	2012-02 → 2012-09

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$0.7276

per ea

Lowest NADAC/Unit

$0.4719

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59762500801MISOPROSTOL 200 MCG TABLET	$0.7276	EA	Generic	—	2026-06-17
59762500802MISOPROSTOL 200 MCG TABLET	$0.7276	EA	Generic	—	2026-06-17
59762500701MISOPROSTOL 100 MCG TABLET	$0.4719	EA	Generic	—	2026-06-17
59762500702MISOPROSTOL 100 MCG TABLET	$0.4719	EA	Generic	—	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 | 14 NDCs (7 FSS, 7 Big4)

Lowest Price

$12.25

Highest Price

$578.93

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59762-5007-01MISOPROSTOL 100MCG TAB	$24.52	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-5007-01MISOPROSTOL 100MCG TAB	$12.25	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-5007-02MISOPROSTOL 100MCG TAB	$53.31	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-5007-02MISOPROSTOL 100MCG TAB	$31.10	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-5008-01MISOPROSTOL 200MCG TAB	$44.32	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-5008-01MISOPROSTOL 200MCG TAB	$14.89	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027

Showing 6 of 14 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Cytotec (2024)

Total Spending

$27K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$5.44

Spending Trend

$59K(2019)→$36K(2020)→$50K(2021)→$41K(2022)→$33K(2023)→$27K(2024)

YoY Change:-9.8%

5yr CAGR:+1.5%

Source: CMS Medicare Part D Spending by Drug (2024). 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