Viewing data from:

ATELVIA

NDA

RISEDRONATE SODIUM | N022560 | ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Expired (1)Active (2)Today

2026

2027

2028

Today

7645459

Jan. 9, 2028

7645460

Jan. 9, 2028

8246989

Jan. 16, 2026

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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
WARNER CHILCOTT COMPANY, LLC et al v. TEVA PHARMACEUTICALS USA, INC. et al 2:2011cv06936 2 patentsANDA 203217risedronate sodium	D.N.J.	2011-11-22	Terminated 2015-03-04	—
WARNER CHILCOTT COMPANY, LLC et al v. AMNEAL PHARMACEUTICALS, LLC, et al 2:2011cv05989 3 patentsANDA 203090risedronate sodium	D.N.J.	2011-10-12	Terminated 2014-07-07	—

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

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 Atelvia (2023)

Total Spending

$224K

Total Claims

476

Beneficiaries

117

Avg Cost/Unit

$68.11

Spending Trend

$910K(2019)→$606K(2020)→$399K(2021)→$293K(2022)→$224K(2023)

YoY Change:+1.1%

5yr CAGR:+1.1%

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

API Supply Chain12 active DMFs5 inactive

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

TAPI NL BVRISEDRONATE SODIUM

DMF 166042003

JUBILANT BIOSYS LTDRISEDRONATE SODIUM HEMIPENTAHYDRATE-USP

DMF 199682006

CIPLA LTDRISEDRONATE SODIUM HEMI PENTAHYDRATE USP

DMF 201622007

MATRIX PHARMACORP PRIVATE LTDRISEDRONATE SODIUM USP (HEMI-PENTAHYDRATE)

DMF 203982007

SYNTHIMED LABS PRIVATE LTDRISEDRONATE SODIUM HEMIPENTAHYDRATE USP

DMF 210332007

APITORIA PHARMA PRIVATE LTDRISEDRONATE SODIUM HEMIPENTAHYDRATE USAP (NON-STERILE DRUG SUBSTANCE)

DMF 211212007

SUN PHARMACEUTICAL INDUSTRIES LTDRISEDRONATE SODIUM HEMI-PENTAHYDRATE USP

DMF 215292008

APOTEX INCRISEDRONATE SODIUM HEMIPENTAHYDRATE USP

DMF 218192008

MACLEODS PHARMACEUTICALS LTDRISEDRONATE SODIUM

DMF 237382010

ALCHYMARS ICM SM PRIVATE LTDRISEDRONATE SODIUM USP

DMF 245912011

ORBION PHARMACEUTICALS PRIVATE LTDRISEDRONATE SODIUM

DMF 257682012

IPCA LABORATORIES LTDRISEDRONATE SODIUM HEMI-PENTAHYDRATE USP

DMF 272522013

DIVIS LABORATORIES LTDInactiveRISEDRONATE SODIUM

DMF 188072005

DR REDDYS LABORATORIES LTDInactiveRISEDRONATE SODIUM HEMIPENTAHYDRATE

DMF 214472008

IPCA LABORATORIES LTDInactiveRISEDRONATE SODIUM HEMI-PENTAHYDRATE USP

DMF 237592010

PHARMAZELL VIZAG PRIVATE LTDInactiveRISEDRONATE SODIUM HEMIPENTAHYDRATE USP

DMF 250072011

HETERO DRUGS LTDInactiveRISEDRONATE SODIUM HEMI-PENTAHYDRATE, USP

DMF 271972013

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Feb 5, 2026	SUPPL -13	View Letter (PDF)
Aug 19, 2020	SUPPL -11	View Letter (PDF)
Apr 13, 2015	SUPPL -7	View Letter (PDF)
Mar 27, 2015	SUPPL -6	View Letter (PDF)
Apr 24, 2013	SUPPL -5	View Letter (PDF)
Aug 15, 2012	SUPPL -4	View Letter (PDF)
Aug 24, 2011	SUPPL -3	View Letter (PDF)
Feb 15, 2011	SUPPL -2	View Letter (PDF)
Feb 15, 2011	SUPPL -1	View Letter (PDF)
Oct 19, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 35MG

RLDAB

3 patents0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: Oct 8, 2010

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7645459	Jan 9, 2028	—	—	Yes		—
7645460	Jan 9, 2028	—	—	Yes		—
8246989	Jan 16, 2026	—	—	Yes	—	—