RISEDRONATE SODIUM - Generic Drug Details
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What are the generic drug sources for risedronate sodium and what is the scope of freedom to operate?
Risedronate sodium
is the generic ingredient in three branded drugs marketed by Apil, Impax Labs Inc, Sun Pharm, Teva Pharms Usa, Zydus Pharms, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Hangzhou Binjiang, Macleods Pharms Ltd, Norvium Bioscience, and Orbion Pharms, and is included in sixteen NDAs. There are three patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Risedronate sodium has eighty-four patent family members in thirty-three countries.
There are seventeen drug master file entries for risedronate sodium. Thirteen suppliers are listed for this compound.
Summary for RISEDRONATE SODIUM
International Patents: | 84 |
US Patents: | 3 |
Tradenames: | 3 |
Applicants: | 12 |
NDAs: | 16 |
Drug Master File Entries: | 17 |
Finished Product Suppliers / Packagers: | 13 |
Raw Ingredient (Bulk) Api Vendors: | 87 |
Clinical Trials: | 16 |
Patent Applications: | 3,588 |
Drug Prices: | Drug price trends for RISEDRONATE SODIUM |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RISEDRONATE SODIUM |
What excipients (inactive ingredients) are in RISEDRONATE SODIUM? | RISEDRONATE SODIUM excipients list |
DailyMed Link: | RISEDRONATE SODIUM at DailyMed |
Recent Clinical Trials for RISEDRONATE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sheffield Children's NHS Foundation Trust | Phase 2 |
Takeda | |
Chugai Pharmaceutical | Phase 3 |
Pharmacology for RISEDRONATE SODIUM
Drug Class | Bisphosphonate |
Medical Subject Heading (MeSH) Categories for RISEDRONATE SODIUM
Paragraph IV (Patent) Challenges for RISEDRONATE SODIUM
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ATELVIA | Delayed-release Tablets | risedronate sodium | 35 mg | 022560 | 1 | 2011-06-09 |
ACTONEL | Tablets | risedronate sodium | 150 mg | 020835 | 1 | 2008-08-12 |
ACTONEL | Tablets | risedronate sodium | 75 mg | 020835 | 1 | 2007-09-07 |
ACTONEL | Tablets | risedronate sodium | 5 mg, 30 mg and 35 mg | 020835 | 1 | 2004-04-23 |
US Patents and Regulatory Information for RISEDRONATE SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Norvium Bioscience | RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 200477-002 | Nov 30, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Macleods Pharms Ltd | RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 203533-002 | Dec 9, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Apil | ATELVIA | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 022560-001 | Oct 8, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Apil | ATELVIA | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 022560-001 | Oct 8, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Apotex | RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 090877-002 | Jun 10, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms Usa | RISEDRONATE SODIUM | risedronate sodium | TABLET, DELAYED RELEASE;ORAL | 203217-001 | May 18, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms Usa | RISEDRONATE SODIUM | risedronate sodium | TABLET;ORAL | 079215-001 | Jun 13, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for RISEDRONATE SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-002 | Apr 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-004 | Apr 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-003 | May 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-003 | May 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-002 | Apr 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-004 | Apr 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-003 | May 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RISEDRONATE SODIUM
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Slovenia | 1753395 | ⤷ Sign Up | |
Portugal | 2269584 | ⤷ Sign Up | |
European Patent Office | 1753395 | ENTERIC SOLID ORAL DOSAGE FORM OF A BISPHOSPHONATE CONTAINING A CHELATING AGENT | ⤷ Sign Up |
Germany | 602005022578 | ⤷ Sign Up | |
South Korea | 20080083068 | ⤷ Sign Up | |
Argentina | 098686 | ⤷ Sign Up | |
Morocco | 29681 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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