Viewing data from:

BONJESTA

NDA

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE | N209661 | DUCHESNAY INC

1 strength4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2027

2028

2029

2030

2031

2032

2033

Today

Feb. 18, 2033

Feb. 18, 2033

Feb. 18, 2033

Feb. 18, 2033

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Duchesnay Inc. v. Actavis Laboratories FL, Inc. et al 1:2018cv01895 4 patentsANDA 212472Doxylamine succinate and pyridoxine hydrochloride	D. Del.	2018-11-29	Terminated 2020-05-14	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy NCT00614445	Phase 3	Completed	Duchesnay Inc.	280	2008-01 → 2009-12
A Study to Investigate Differences in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions NCT03905564	Phase 1	Withdrawn	Grünenthal GmbH	—	2019-06 → 2020-06

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

$11.12

per ea

Lowest NADAC/Unit

$11.12

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
55494012060BONJESTA ER 20-20 MG TABLET	$11.12	EA	Brand	—	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 | 1 NDC (1 FSS)

Lowest Price

$514.67

Highest Price

$514.67

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
55494-0120-60BONJESTA TABS	$514.67	FSS	Duchesnay USA, Inc.	06/30/2027

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

Medicare Part D Spending

CMS annual spending data for Bonjesta (2024)

Total Spending

$47K

Total Claims

Beneficiaries

Avg Cost/Unit

$11.40

Spending Trend

$68K(2019)→$32K(2020)→$46K(2021)→$28K(2022)→$39K(2023)→$47K(2024)

YoY Change:-8.6%

5yr CAGR:+0.5%

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Nov 1, 2022	SUPPL -8	View Letter (PDF)
Jun 21, 2018	SUPPL -4	View Letter (PDF)
Nov 9, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG;20MG

RLD

4 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 7, 2016

Patents (4) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
9089489	Feb 18, 2033	—	—	Yes	—
9375404	Feb 18, 2033	—	—	Yes	—
9526703	Feb 18, 2033	—	—	Yes	—
9937132	Feb 18, 2033	—	—	Yes	—