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NUZYRA

NDA

OMADACYCLINE TOSYLATE | N209816 | PARATEK PHARMACEUTICALS INC

1 strength8 unique patents2 unique exclusivities

Patent Timeline

8 unique patents, 2 exclusivities by expiration date

Active (8)TodayExclusivity

2024

2025

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

Today

Sep. 23, 2030

Oct. 24, 2030

Mar. 18, 2031

Mar. 5, 2029

Aug. 3, 2037

Mar. 5, 2029

Oct. 31, 2037

Oct. 31, 2037

NCE

Oct. 2, 2023

GAIN

Oct. 2, 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Nuzyra* (2023)

Total Spending

$73.2M

Total Claims

7,417

Beneficiaries

3,687

Avg Cost/Unit

$250.00

Spending Trend

$2.9M(2019)→$11.4M(2020)→$23.6M(2021)→$44.1M(2022)→$73.2M(2023)

YoY Change:+8.1%

5yr CAGR:+7.9%

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

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SICHUAN KELUN PHARMACEUTICAL CO LTDOMADACYCLINE TOSYLATE

DMF 416412025

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDOMADACYCLINE TOSYLATE

DMF 432482025

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
May 15, 2026	SUPPL -18	View Letter (PDF)
Apr 8, 2025	SUPPL -17	View Letter (PDF)
Jun 1, 2021	SUPPL -11	View Letter (PDF)
Jan 12, 2021	SUPPL -12	View Letter (PDF)
Oct 21, 2020	SUPPL -9	View Letter (PDF)
Sep 3, 2020	SUPPL -8	View Letter (PDF)
Jun 17, 2019	SUPPL -4	View Letter (PDF)
Jun 17, 2019	SUPPL -3	View Letter (PDF)
Jun 17, 2019	SUPPL -2	View Letter (PDF)
Oct 3, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 150MG BASE

RLD

8 patents2 exclusivities▴

TABLET;ORAL | Approved: Oct 2, 2018

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8383610	Sep 23, 2030	—	Yes	—	—	—
9265740	Oct 24, 2030	—	—	Yes		—
9314475	Mar 18, 2031	—	—	Yes	—	—
9724358	Mar 5, 2029	—	—	—		—
10111890	Aug 3, 2037	—	—	—		—
10124014	Mar 5, 2029	—	—	—		—
10383884	Oct 31, 2037	—	—	—		—
10835542	Oct 31, 2037	—	—	—		—

Exclusivities (2)

Code	Date	Status
GAIN	Oct 2, 2028	Active
NCE	Oct 2, 2023	Expired