Viewing data from:

SEYSARA

NDA

SARECYCLINE HYDROCHLORIDE | N209521 | ALMIRALL LLC

3 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2027

2028

2029

2030

2031

2032

2033

Today

Jan. 3, 2032

Dec. 7, 2029

Feb. 9, 2033

Aug. 10, 2028

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris NCT01628549	Phase 2	Completed	Almirall, S.A.	285	2012-06-30 → 2013-01-31

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

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$794.62

Highest Price

$826.18

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
16110-0245-30SEYSARA 60MG TAB	$794.62	FSS	Almirall, LLC	05/14/2030
16110-0245-30SEYSARA 60MG TAB	$794.62	Big4	Almirall, LLC	05/14/2030
16110-0246-30SEYSARA 100MG TAB	$794.62	Big4	Almirall, LLC	05/14/2030
16110-0246-30SEYSARA 100MG TAB	$794.62	FSS	Almirall, LLC	05/14/2030
16110-0247-30SEYSARA 150MG TAB	$826.18	FSS	Almirall, LLC	05/14/2030
16110-0247-30SEYSARA 150MG TAB	$803.31	Big4	Almirall, LLC	05/14/2030

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

Medicare Part D Spending

CMS annual spending data for Seysara (2024)

Total Spending

$786K

Total Claims

637

Beneficiaries

200

Avg Cost/Unit

$33.78

Spending Trend

$164K(2020)→$417K(2021)→$536K(2022)→$658K(2023)→$786K(2024)

YoY Change:-3.8%

5yr CAGR:+2.5%

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Mar 31, 2023	SUPPL -15	View Letter (PDF)
Mar 31, 2023	SUPPL -16	View Letter (PDF)
Jun 2, 2020	SUPPL -7	View Letter (PDF)
Apr 10, 2019	SUPPL -1	View Letter (PDF)
Oct 1, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 60MG BASE

RLD

4 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 1, 2018

Patents (4) · 5 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
8318706	Jan 3, 2032	—	Yes	Yes	—
8513223	Dec 7, 2029	—	—	—	—
9255068	Feb 9, 2033	—	Yes	Yes	—
9481639	Aug 10, 2028	—	—	—	—

#002 — EQ 100MG BASE

RLD

4 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 1, 2018

#003 — EQ 150MG BASE

RLD

4 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 1, 2018