Viewing data from:

INDERAL LA

NDA

PROPRANOLOL HYDROCHLORIDE | N018553 | ANI PHARMACEUTICALS INC

4 strengths0 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

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from ROXANE LABORATORIES, INC FDA-1985-P-0240 · 3 docket documents Roxane Laboratories, Inc. submitted this petition under Section 314.110(f) of the Food, Drug and Cosmetic Act requesting that the FDA determine ANDA suitability for Propranolol Hydrochloride Oral Solution, 20 mg per 5 ml, arguing that the product offers a valuable alternative dosage form to existing	Other	2023-10-18	Granted	ROXANE LABORATORIES, INC
Verex Laboratories Inc. - Citizen Petition FDA-1985-P-0019 · 5 docket documents Verex Laboratories, Inc. filed this citizen petition under 21 CFR 10.30 and Section 314.2(c)(d) on March 20, 1985, requesting that the FDA Commissioner find an Abbreviated New Drug Application suitable for propranolol HCl 160 mg constant-release-rate tablets marketed as PROBLOK, a tablet formulation	Other	2012-09-06	Granted	—
Citizen Petition from Flemington Pharmaceutical Corporation FDA-1992-P-0493 · 5 docket documents Flemington Pharmaceutical Corporation filed this citizen petition under section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.55(d) requesting permission to file an Abbreviated New Drug Application for effervescent propranolol hydrochloride tablets 40 mg, which differs from	Other	2008-10-15	Withdrawn	Flemington Pharmaceutical Corporation

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

208 trials from ClinicalTrials.gov — 3 recruiting, 2 active, 111 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Modafinil and Cognitive Function in POTS NCT01988883	Early Phase 1	Active	Vanderbilt University Medical Center	20	2014-10 → 2026-12
Treatment of Orthostatic Intolerance NCT00262470	Phase 1/2	Active	Satish R. Raj	150	1997-04 → 2029-12
Colorectal Metastasis Prevention International Trial 2 NCT03919461	Phase 2	Recruiting	Assaf-Harofeh Medical Center	200	2019-02-28 → 2027-02-28
Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity NCT03083431	Phase 2	Recruiting	University of Zurich	276	2022-09-22 → 2029-12-31
Crossover Study of Propranolol vs Ivabradine in POTS NCT04186286	Phase 2	Recruiting	University of Calgary	20	2021-02-01 → 2026-12-31
Effect of Medical Treatment and Prognosis of Postural Orthostatic Tachycardia Syndrome (POTS)NCT02171988	Phase 4	Completed	Seoul National University Hospital	150	2014-03 → 2016-12
Propranolol and Botulinum Toxin for Essential Vocal Tremor NCT02111369	Phase 4	Completed	Emory University	18	2014-05 → 2014-11
Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate NCT01950520	Phase 2	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	47	2014-02-07 → 2024-06-11
Study of Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in HCT Recipients NCT02420223	Phase 2	Completed	Medical College of Wisconsin	25	2015-07-17 → 2020-02
The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma NCT01908972	Phase 4	Completed	Seoul National University Hospital	34	2013-06 → 2015-05

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$77.62

per ea

Lowest NADAC/Unit

$77.62

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62559052201INDERAL LA 120 MG CAPSULE	$77.62	EA	Brand	$0.1921	2025-08-20
62559052230INDERAL LA 120 MG CAPSULE	$77.62	EA	Brand	$0.1921	2025-08-20

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 16 NDCs (8 FSS, 8 Big4)

Lowest Price

$1403.37

Highest Price

$8348.68

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62559-0521-30INDERAL LA 80MG CAP	$2178.61	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0521-30INDERAL LA 80MG CAP	$1648.00	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0522-01INDERAL LA 120MG CAP	$7997.43	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0522-01INDERAL LA 120MG CAP	$5942.62	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0522-30INDERAL LA 120MG CAP	$2399.23	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0522-30INDERAL LA 120MG CAP	$1818.67	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027

Showing 6 of 16 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Inderal La (2024)

Total Spending

$7.2M

Total Claims

1,324

Beneficiaries

261

Avg Cost/Unit

$71.25

Spending Trend

$13.8M(2019)→$12.8M(2020)→$11.4M(2021)→$9.5M(2022)→$8.2M(2023)→$7.2M(2024)

YoY Change:-3.9%

5yr CAGR:+1.6%

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

API Supply Chain7 active DMFs7 inactive

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

SIMS SRLPROPRANOLOL HYDROCHLORIDE

DMF 51391983

W R GRACE AND CO -CONNPROPRANOLOL HYDROCHLORIDE

DMF 58611985

IPCA LABORATORIES LTDPROPRANOLOL HYDROCHLORIDE USP

DMF 158492002

MANKIND PHARMA LTDPROPRANOLOL HYDROCHLORIDE USP

DMF 356352021

MACLEODS PHARMACEUTICALS LTDPROPRANOLOL HYDROCHLORIDE USP

DMF 397522024

ALIVUS LIFE SCIENCES LTDPROPRANOLOL HYDROCHLORIDE USP

DMF 397822024

RAKS PHARMA PVT LTDPROPRANOLOL HYDROCHLORIDE USP

DMF 423982025

LUSOCHIMICA SPAInactivePROPRANOLOL HYDROCHLORIDE USP XX, NF XV

DMF 49821983

UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTDInactivePROPRANOLOL HYDROCHLORIDE (U.S.P.)

DMF 53251984

KOTHARI PHYTOCHEMICALS INTERNATIONALInactivePROPRANOLOL HYDROCHLORIDE

DMF 59371985

MTM CHEMICALS INCInactivePROPRANOLOL HYDROCHLORIDE,BULK

DMF 61021985

BOEHRINGER KNOLL LTDInactivePROPRANOLOL HYDROCHLORIDE

DMF 83091989

CYANAMID UK LTDInactivePROPRANOLOL HYDROCHLORIDE

DMF 93121991

LUPIN LTDInactivePROPRANOLOL HYDROCHLORIDE USP

DMF 332222018

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Nov 8, 2023	SUPPL -48	View Letter (PDF)
Nov 8, 2023	SUPPL -52	View Letter (PDF)
Mar 23, 2011	SUPPL -37	View Letter (PDF)
Nov 8, 2007	SUPPL -36	View Letter (PDF)
Mar 6, 2007	SUPPL -35	View Letter (PDF)
Jan 8, 2007	SUPPL -34	View Letter (PDF)
Jun 10, 2004	SUPPL -30	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 160MG

RLDAB

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Apr 19, 1983

No patent or exclusivity listings for this strength.

#002 — 80MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Apr 19, 1983

#003 — 120MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Apr 19, 1983

#004 — 60MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Mar 18, 1987