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SUPREP BOWEL PREP KIT

NDA

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | N022372 | AZURITY PHARMACEUTICALS INC

1 strength0 unique patents1 unique exclusivity

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

2027

Today

ODE-315

Aug. 5, 2027

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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Braintree Laboratories, Inc. v. Alkem Laboratories Limited et al 1:2020cv00362	D. Del.	2020-03-13	Terminated 2020-04-27	—
BRAINTREE LABORATORIES, INC. v. HETERO LABS LIMITED et al 3:2019cv15676 1 patentANDA 212903sodium sulfate, potassium sulfate and magnesium sulfate	D.N.J.	2019-07-22	Terminated 2019-10-28	—
BRAINTREE LABORATORIES, INC. v. GATOR PHARMACEUTICALS, INC. et al 2:2013cv01975 1 patentsodium sulfate, potassium sulfate, magnesium sulfate	E.D. Pa.	2013-04-15	Terminated 2013-08-05	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

296 trials from ClinicalTrials.gov — 3 recruiting, 2 active, 187 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
First in Men Study: BIOMAG-I NCT04157153	N/A	Active	Biotronik AG	116	2020-04-27 → 2027-02
Potential Therapeutic Role of Effervescent Calcium-Magnesium Citrate in Chronic Kidney Disease Stage V NCT03565913	Phase 2/3	Active	University of Texas Southwestern Medical Center	269	2017-01-22 → 2026-12-18
MLD10 for the Treatment of Hypomagnesemic Patients With Type 2 Diabetes Mellitus NCT03567824	Phase 2	Not Yet Recruiting	Pharmalyte Solutions LLC	200	2026-03-01 → 2028-04-30
Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards NCT03088852	Phase 4	Recruiting	Frieda Wolf	330	2017-05-10 → 2026-12
Magnesium Infusion for Pain Management in Critically Ill Trauma Patients NCT04166877	Phase 4	Recruiting	University of California, Davis	156	2019-12-07 → 2026-12-31
Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity NCT02481518	Phase 4	Completed	Mahidol University	30	2015-03 → 2016-03
Magnesium Sulfate and Bupivacaine for Rehabilitation After Distal Radius Fractures NCT02514343	N/A	Completed	Universidad Autonoma de Nuevo Leon	40	2015-07 → 2017-12
Comparison of Intra-articular Dexmedetomidine and Magnesium in Postoperative Pain NCT03479216	Phase 4	Completed	Derince Training and Research Hospital	62	2018-03-26 → 2018-08-01
Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4 NCT01856959	N/A	Completed	Chongqing Medical University	330	2011-11 → 2013-05
Ketamine Versus Magnesium Sulphate as Adjuvants for ESPB in Breast Cancer Surgery NCT04275661	Phase 2	Completed	Assiut University	60	2020-08-01 → 2022-04-30

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs (1 brand, 1 generic)

Highest NADAC/Unit

$0.3242

per ml

Lowest NADAC/Unit

$0.1054

per ml

Brand NDCs

Generic NDCs

Avg Brand: $0.3242

Avg Generic: $0.1054

67% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
52268001201SUPREP BOWEL PREP KIT	$0.3242	ML	Brand	$0.1054	2026-06-17
10572001201SOD SUL-POTASS SUL-MAG SUL SOL	$0.1054	ML	Generic	—	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 | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$14.29

Highest Price

$50.33

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
52268-0012-01SUPREP BOWEL PREP KIT	$50.33	FSS	Sebela Pharmaceuticals, Inc.	03/31/2029
52268-0012-01SUPREP BOWEL PREP KIT	$50.33	Big4	Sebela Pharmaceuticals, Inc.	03/31/2029
10572-0012-01SODIUM,POTASSIUM,MAG SULFATES	$20.76	FSS	Sebela Pharmaceuticals, Inc.	03/31/2029
10572-0012-01SODIUM,POTASSIUM,MAG SULFATES	$14.29	Big4	Sebela Pharmaceuticals, Inc.	03/31/2029

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Nov 19, 2025	SUPPL -16	View Letter (PDF)
Aug 6, 2020	SUPPL -13	View Letter (PDF)
Nov 6, 2012	SUPPL -4	View Letter (PDF)
Jul 12, 2011	SUPPL -3	View Letter (PDF)
Aug 10, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

RLDAA

0 patents1 exclusivity▴

SOLUTION;ORAL | Approved: Aug 5, 2010

Exclusivities (1)

Code	Date	Status
ODE-315	Aug 5, 2027	Active