Active substance
Risedronic acid
- US FDA 17
- Health Canada 20
- US price lines 7
- NHS prices 3
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ACTONEL | 35MG; 150MG | tablet · oral | APIL | Prescription | 27 Mar 1998 |
| RISEDRONATE SODIUM | 5MG; 30MG; 35MG | tablet · oral | TEVA PHARMS USA | Prescription | 5 Oct 2007 |
| ATELVIA | 35MG | tablet, delayed release · oral | APIL | Prescription | 8 Oct 2010 |
| RISEDRONATE SODIUM | 35MG; 75MG; 150MG | tablet · oral | APOTEX | Prescription | 10 Jun 2014 |
| RISEDRONATE SODIUM | 5MG; 30MG; 35MG; 75MG; 150MG | tablet · oral | SUN PHARM | Prescription | 10 Jun 2014 |
| RISEDRONATE SODIUM | 150MG | tablet · oral | TEVA PHARMS USA | Prescription | 13 Jun 2014 |
| RISEDRONATE SODIUM | 35MG | tablet, delayed release · oral | TEVA PHARMS USA | Prescription | 18 May 2015 |
| RISEDRONATE SODIUM | 5MG; 30MG; 35MG | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 30 Nov 2015 |
| RISEDRONATE SODIUM | 5MG; 30MG; 35MG | tablet · oral | MACLEODS PHARMS | Prescription | 9 Dec 2015 |
| RISEDRONATE SODIUM | 150MG | tablet · oral | AUROBINDO PHARMA | Prescription | 21 Oct 2016 |
| RISEDRONATE SODIUM | 30MG; 35MG | tablet · oral | ORBION PHARMS | Prescription | 13 May 2019 |
| ACTONEL | 30MG; 5MG; 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | APIL | Discontinued | 27 Mar 1998 |
| RISEDRONATE SODIUM | 5MG; 30MG; 35MG; 75MG; 150MG | tablet · oral | PHARMOBEDIENT | Discontinued | 10 Jun 2014 |
| RISEDRONATE SODIUM | 35MG | tablet, delayed release · oral | IMPAX LABS INC | Discontinued | 29 Jun 2018 |
| RISEDRONATE SODIUM | 35MG | tablet, delayed release · oral | ZYDUS PHARMS | Discontinued | 11 Sep 2018 |
| RISEDRONATE SODIUM | 35MG | tablet · oral | HANGZHOU BINJIANG | Discontinued | 15 Feb 2019 |
| RISEDRONATE SODIUM | 35MG | tablet, delayed release · oral | SUN PHARM | Discontinued | 9 Jul 2019 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AA-RISEDRONATE DR | 02493268 | 35 MG | TABLET (DELAYED-RELEASE) · ORAL | AA PHARMA INC |
| ACTONEL | 02246896 | 35 MG | TABLET · ORAL | ABBVIE CORPORATION |
| ACTONEL | 02316838 | 150 MG | TABLET · ORAL | ABBVIE CORPORATION |
| ACTONEL DR | 02370417 | 35 MG | TABLET (DELAYED-RELEASE) · ORAL | ABBVIE CORPORATION |
| APO-RISEDRONATE | 02353687 | 35 MG | TABLET · ORAL | APOTEX INC |
| APO-RISEDRONATE | 02377721 | 150 MG | TABLET · ORAL | APOTEX INC |
| AURO-RISEDRONATE | 02406306 | 35 MG | TABLET · ORAL | AURO PHARMA INC |
| NB-RISEDRONATE | 02561859 | 35 MG | TABLET · ORAL | NB PHARMA INC. |
| PMS-RISEDRONATE | 02302209 | 35 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PMS-RISEDRONATE | 02424177 | 150 MG | TABLET · ORAL | PHARMASCIENCE INC |
| RISEDRONATE | 02347474 | 35 MG | TABLET · ORAL | PRO DOC LIMITEE |
| RISEDRONATE | 02370255 | 35 MG | TABLET · ORAL | SANIS HEALTH INC |
| RISEDRONATE | 02411407 | 35 MG | TABLET · ORAL | SIVEM PHARMACEUTICALS ULC |
| RISEDRONATE | 02528460 | 150 MG | TABLET · ORAL | SANIS HEALTH INC |
| RIVA-RISEDRONATE | 02341077 | 35 MG | TABLET · ORAL | LABORATOIRE RIVA INC. |
| SANDOZ RISEDRONATE | 02327295 | 35 MG | TABLET · ORAL | SANDOZ CANADA INCORPORATED |
| TEVA-RISEDRONATE | 02298376 | 5 MG | TABLET · ORAL | TEVA CANADA LIMITED |
| TEVA-RISEDRONATE | 02298384 | 30 MG | TABLET · ORAL | TEVA CANADA LIMITED |
| TEVA-RISEDRONATE | 02298392 | 35 MG | TABLET · ORAL | TEVA CANADA LIMITED |
| TEVA-RISEDRONATE | 02413809 | 150 MG | TABLET · ORAL | TEVA CANADA LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | ACTONEL 35 MG TABLET | $81.8555 | per EA | 21 Jan 2026 |
| US NADAC | ATELVIA DR 35 MG TABLET | $63.80786 | per EA | 23 Sep 2026 |
| US NADAC | RISEDRONATE SOD DR 35 MG TAB | $30.67721 | per EA | 23 Sep 2026 |
| US NADAC | RISEDRONATE SODIUM 150 MG TAB | $12.90725 | per EA | 23 Sep 2026 |
| US NADAC | RISEDRONATE SODIUM 35 MG TAB | $1.59807 | per EA | 23 Sep 2026 |
| US NADAC | RISEDRONATE SODIUM 35 MG TABLET | $1.59807 | per EA | 23 Sep 2026 |
| US NADAC | RISEDRONATE SODIUM 5 MG TABLET | $1.51515 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Risedronate sodium 30mg tablets | £143.83 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Risedronate sodium 35mg tablets | £1.06 | 4 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Risedronate sodium 5mg tablets | £20.87 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- EMA PRAC 10 Sep 2015 PRAC signal: Osteonecrosis of the external auditory canal
Action for MAH: update of the product information: Yes - EMA PRAC 12 Mar 2015 PRAC signal: Osteonecrosis of the external auditory canal
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.