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AZASITE

NDA

AZITHROMYCIN | N050810 | THEA PHARMA INC

1 strength0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

364 trials from ClinicalTrials.gov — 4 recruiting, 8 active, 229 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth NCT00131235	Phase 3	Active	Tampere University	1,320	2003-12 → 2027-12-31
Improving Care Through Azithromycin Research for Infants in Africa NCT04235816	Phase 3	Active	Barcelona Institute for Global Health	20,560	2021-03-15 → 2026-04-30
Kebele Elimination of Trachoma for Ocular Health NCT03335072	Phase 4	Active	University of California, San Francisco	320,000	2022-02-07 → 2028-03-01
Single Dose Azithromycin to Prevent Cholera in Children NCT04326478	Phase 2	Active	Massachusetts General Hospital	920	2021-10-31 → 2026-05-31
Incidence of Acute Laryngeal Injury Following Endotracheal Intubation NCT03250975	Phase 1/2	Active	Vanderbilt University Medical Center	64	2017-08-19 → 2026-12-30
Scrub Typhus Antibiotic Resistance Trial NCT03083197	Phase 4	Active	University of Oxford	177	2017-10-15 → 2028-10
Oral Azithromycin to Prevent Stillbirths and Infant Mortality in Mali NCT03909737	Phase 4	Active	University of Maryland, Baltimore	99,700	2020-09-24 → 2026-03-31
Antibiotic Treatment of Recurrent Episodes of Asthma in Children NCT01233297	Phase 2	Active	Copenhagen Studies on Asthma in Childhood	70	2010-11 → 2033-10
Chronic Airway Disease, Mucus Rheology and Exacerbations NCT04339270	Phase 4	Recruiting	University Hospital, Montpellier	72	2023-02-03 → 2026-02
CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections NCT03236987	Phase 3	Recruiting	Centre Hospitalier Universitaire, Amiens	424	2018-02-05 → 2029-02-05

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

$98.35

per ml

Lowest NADAC/Unit

$98.35

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
82584030703AZASITE 1% EYE DROPS	$98.35	ML	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

$175.89

Highest Price

$175.89

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82584-0307-03AZASITE 1% SOLN,OPH	$175.89	FSS	Thea Pharma, Inc.	01/31/2028

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

Medicare Part D Spending

CMS annual spending data for Azasite (2024)

Total Spending

$1.6M

Total Claims

5,084

Beneficiaries

3,244

Avg Cost/Unit

$99.61

Spending Trend

$5.2M(2019)→$4.7M(2020)→$3.4M(2021)→$839K(2022)→$1.3M(2023)→$1.6M(2024)

YoY Change:+1.8%

5yr CAGR:+1.8%

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

API Supply Chain24 active DMFs13 inactive

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

TAPI NL BVAZITHROMYCIN MONOHYDRATE

DMF 152612001

TAPI NL BVAZITHROMYCIN DIHYDRATE

DMF 159722002

TAPI NL BVAZITHROMYCIN N

DMF 159852002

ALEMBIC PHARMACEUTICALS LTDAZITHROMYCIN MONOHYDRATE USP

DMF 187192005

JUBILANT BIOSYS LTDAZITHROMYCIN MONOHYDRATE USP

DMF 188682005

ALEMBIC PHARMACEUTICALS LTDAZITHROMYCIN DIHYDRATE USP

DMF 207542007

CSPC OUYI PHARMACEUTICAL CO LTDAZITHROMYCIN

DMF 223312008

ALEMBIC PHARMACEUTICALS LTDAZITHROMYCIN MONOHYDRATE USP (PROCESS-II)

DMF 247542011

LUPIN MANUFACTURING SOLUTIONS LTDAZITHROMYCIN MONOHYDRATE USP (PROCESS B)

DMF 258202012

CALYX CHEMICALS AND PHARMACEUTICALS LTDAZITHROMYCIN MONOHYDRATE

DMF 277132013

MAHIMA LIFE SCIENCES PRIVATE LTDAZITHROMYCIN USP (DIHYDRATE)

DMF 278852013

TARO PHARMACEUTICAL INDUSTRIES LTDAZITHROMYCIN MONOHYDRATE USP

DMF 282942015

HEC PHARM CO LTDAZITHROMYCIN DIHYDRATE NON-STERILE DRUG SUBSTANCE BULK FORM

DMF 288372014

STERILE INDIA PVT LTDAZITHROMYCIN (LYOPHILIZED BULK STERILE)

DMF 299862016

JIANGSU WEIQIDA PHARMACEUTICAL CO LTDAZITHROMYCIN DIHYDRATE

DMF 308872016

JUBILANT BIOSYS LTDAZITHROMYCIN DIHYDRATE USP

DMF 309662016

LUPIN MANUFACTURING SOLUTIONS LTDAZITHROMYCIN DIHYDRATE USP

DMF 334842019

CENTURY PHARMACEUTICALS LTDAZITHROMYCIN DIHYDRATE USP

DMF 345832020

KOPRAN RESEARCH LABORATORIES LTDAZITHROMYCIN DIHYDRATE USP

DMF 348532020

ALEMBIC PHARMACEUTICALS LTDAZITHROMYCIN DIHYDRATE USP (ADF PROCESS)

DMF 350342020

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDAZITHROMYCIN DIHYDRATE

DMF 368952022

CALYX CHEMICALS AND PHARMACEUTICALS LTDAZITHROMYCIN DIHYDRATE

DMF 374102022

HUANGSHI SHIXING PHARMACEUTICAL CO LTDAZITHROMYCIN AMINE DRUG SUBSTANCE INTERMEDIATE

DMF 434742026

ZHEJIANG JINHUA CONBA BIO-PHARM CO LTDAZITHROMYCIN, USP

DMF 438782026

WOCKHARDT LTDInactiveAZITHROMYCIN USP

DMF 144801999

SANDOZ INDUSTRIAL PRODUCTS SAInactiveAZITHROMYCIN MONOHYDRATE (NON-STERILE BULK)

DMF 163902003

ITF CHEMICAL LTDAInactiveAZITHROMYCIN MONOHYDRATE

DMF 170102005

ALEMBIC LTD API DIVInactiveAZITHROMYCIN MONOHYDRATE

DMF 170912003

QUIMICA SINTETICA SAInactiveAZITHROMYCIN HYDROGENCITRATE

DMF 179512004

LUPIN LTDInactiveAZITHROMYCIN MONOHYDRATE USP

DMF 193262006

SHIJIAZHUANG PHARMACEUTICAL GROUP HUASHENG PHARMA CO LTDInactiveAZITHROMYCIN USP (API)

DMF 200742006

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDInactiveAZITHROMYCIN MONOHYDRATE

DMF 202582007

HEC PHARM CO LTDInactiveAZITHROMYCIN MONHYDRATE, NON-STERILE BULK DRUG SUBSTANCE

DMF 208522007

HAINAN POLY PHARMACEUTICAL CO LTDInactiveAZITHROMYCIN GRANULES FOR ORAL SUSPENSION

DMF 234862010

PJ HEALTHCAREInactiveAZITHROMYCIN TASTE MASKING GRANULES 7.5%

DMF 270672013

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveAZITHROMYCIN MONOHYDRATE

DMF 272952013

RUYUAN HEC PHARM CO LTDInactiveAZITHROMYCIN MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE

DMF 284532014

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Jul 26, 2024	SUPPL -17	View Letter (PDF)
Nov 18, 2021	SUPPL -19	View Letter (PDF)
Jul 9, 2012	SUPPL -14	View Letter (PDF)
Apr 4, 2011	SUPPL -7	View Letter (PDF)
May 11, 2009	SUPPL -5	View Letter (PDF)
May 11, 2009	SUPPL -2	View Letter (PDF)
May 11, 2009	SUPPL -1	View Letter (PDF)
May 1, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Apr 27, 2007

No patent or exclusivity listings for this strength.