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RISEDRONATE SODIUM

ANDA

RISEDRONATE SODIUM | A077132 | TEVA PHARMACEUTICALS USA

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ACTONEL(TE code: AB)

Medicare Part D Spending

CMS annual spending data for Risedronate Sodium (2023)

Total Spending

$27.2M

Total Claims

242,874

Beneficiaries

71,989

Avg Cost/Unit

$32.63

Spending Trend

$38.2M(2019)→$37.4M(2020)→$33.4M(2021)→$31.5M(2022)→$27.2M(2023)

YoY Change:-21.6%

5yr CAGR:-12.0%

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

1 letter from Drugs@FDA

Date	Submission	Document
Oct 10, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 5, 2007

No patent or exclusivity listings for this strength.

#002 — 30MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 5, 2007

#003 — 35MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 5, 2007