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DELALUTIN

NDA

HYDROXYPROGESTERONE CAPROATE | N016911 | BRISTOL MYERS SQUIBB

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

5 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Buchanan Ingersoll and Rooney PC on behalf of Covis Pha... FDA-2021-P-0767 · 3 docket documents Buchanan Ingersoll and Rooney PC, on behalf of Covis Pharma GmbH, filed this petition on July 19, 2021, requesting that the FDA review ANDA 215275 submitted by Eugia Pharma Specialties Ltd. for a generic version of Makena Autoinjector, determine that the ANDA should have been filed as a section 505(	505(q)	2021-07-20	Denied	Covis Pharma GmbH
Citizen Petition from Public Citizen FDA-2019-P-4683 · 6 docket documents Public Citizen, the Health Research Group, and Dr. Adam C. Urato filed this petition on October 8, 2019, requesting that the FDA immediately withdraw approval of all medications containing hydroxyprogesterone caproate, including the brand name product Makena, under sections 505(e), 506(c)(3), 503A,	505(q)	2019-10-08	Denied	Public Citizen
Citizen Petition from The Escher Fund For Autism FDA-2015-P-0876 · 8 docket documents The Escher Fund for Autism filed this citizen petition on March 16, 2015, requesting that the FDA withdraw approval for 17-alpha-hydroxyprogesterone caproate (17-0HPC, brand name Makena) as a pregnancy drug pending assessment of potential fetal germline impacts, citing new safety information regardi	Other	2015-03-23	Denied	The Escher Fund For Autism
KV Pharmaceutical Company - Citizen Petition FDA-2012-P-0637 · 4 docket documents KV Pharmaceutical Company filed this section 505(q) citizen petition on June 15, 2012, requesting that FDA refrain from approving any ANDA referencing Delalutin as a reference listed drug because the objective intended use would infringe upon KV's orphan drug exclusivity for Makena (hydroxyprogester	505(q)	2012-07-06	Denied	—
Citizen Petition from Custopharm, Inc. FDA-2006-P-0089 · 13 docket documents Custopharm, Inc. filed this citizen petition under section 705(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA Commissioner determine that Bristol-Myers Squibb's voluntary withdrawal of Delalutin (Hydroxyprogesterone Caproate) Injection, the subject of NDAs 10-347 and 16-	505(q)	2010-07-01	Granted	Custopharm, Inc.

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

Clinical Trials

18 trials from ClinicalTrials.gov, 11 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood NCT01899846	Phase 1	Completed	Lumara Health, Inc.	30	2013-07 → 2014-08
Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in High Risk Pregnancies NCT00135902	Phase 3	Completed	The George Washington University Biostatistics Center	800	2005-02 → 2008-03
Improving Pregnancy Outcomes With Progesterone NCT03297216	Phase 3	Completed	University of North Carolina, Chapel Hill	800	2018-02-07 → 2020-08-06
Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery NCT01004029	Phase 3	Completed	AMAG Pharmaceuticals, Inc.	1,740	2009-10 → 2018-10
Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM)NCT01119963	Phase 2/3	Completed	Obstetrix Medical Group	152	2011-10 → 2014-10
Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.NCT01050647	Phase 1/2	Completed	Stanford University	21	2010-02 → 2015-12
17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies NCT00163020	Phase 2/3	Completed	Obstetrix Medical Group	321	2004-11 → 2009-08
Comparing IM vs. Vaginal Progesterone for Pre-term Birth NCT00579553	N/A	Completed	University of Oklahoma	174	2006-10 → 2011-05
Study of Pharmacology of 17-OHPC in Pregnancy NCT00409825	Phase 2	Completed	University of Pittsburgh	61	2006-03 → 2014-02
Trial of Progesterone in Twins and Triplets to Prevent Preterm Birth (STTARS)NCT00099164	Phase 3	Completed	The George Washington University Biostatistics Center	795	2004-04 → 2007-09

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

API Supply Chain4 active DMFs5 inactive

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

ASPEN OSS BVHYDROXYPROGESTERONE CAPROATE

DMF 171132004

SUN PHARMACEUTICAL INDUSTRIES LTDHYDROXYPROGESTERONE CAPROATE USP

DMF 289582015

SYMBIOTEC PHARMALAB PRIVATE LTDHYDROXYPROGESTERONE CAPROATE USP

DMF 307472016

STEROID SPAHYDROXYPROGESTERONE CAPROATE

DMF 313372017

UPJOHN COInactiveHYDROXYPROGESTERONE CAPROATE

DMF 28561977

DIOSYNTH BVInactiveHYDROXYPROGESTERONE CAPROATE

DMF 29931977

DIOSYNTH BVInactiveHYDROXYPROGESTERONE CAPROATE

DMF 38451980

SCHERING AGInactiveHYDROXYPROGESTERONE CAPROATE

DMF 53181984

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCInactiveHYDROXYPROGESTERONE CAPROATE USP

DMF 325262018

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

Products (2)

Sort:

#001 — 125MG/ML (125MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 250MG/ML (250MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR | Approved: Approved Prior to Jan 1, 1982