RECLAST Drug Patent Profile
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Which patents cover Reclast, and when can generic versions of Reclast launch?
Reclast is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-nine patent family members in thirty-six countries.
The generic ingredient in RECLAST is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Reclast
A generic version of RECLAST was approved as zoledronic acid by BRECKENRIDGE on March 4th, 2013.
Summary for RECLAST
International Patents: | 69 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 112 |
Clinical Trials: | 26 |
Patent Applications: | 2,772 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for RECLAST |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RECLAST |
What excipients (inactive ingredients) are in RECLAST? | RECLAST excipients list |
DailyMed Link: | RECLAST at DailyMed |


Recent Clinical Trials for RECLAST
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Australian and New Zealand Intensive Care Research Centre | Phase 2 |
University of Nebraska | Phase 1/Phase 2 |
San Francisco VA Health Care System | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for RECLAST
Paragraph IV (Patent) Challenges for RECLAST
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
RECLAST | Injection | zoledronic acid | 0.05 mg/mL, 100 mL vial | 021817 | 1 | 2008-08-29 |
US Patents and Regulatory Information for RECLAST
RECLAST is protected by two US patents.
Patents protecting RECLAST
Pharmaceutical products comprising bisphosphonates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Method of administering bisphosphonates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT AND PREVENTION OF POSTMENOPAUSAL OR GLUCOCORTICOID-INDUCED OSTEOPOROSIS AND TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | RECLAST | zoledronic acid | INJECTABLE;INTRAVENOUS | 021817-001 | Apr 16, 2007 | AP | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Novartis | RECLAST | zoledronic acid | INJECTABLE;INTRAVENOUS | 021817-001 | Apr 16, 2007 | AP | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
>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 RECLAST
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | RECLAST | zoledronic acid | INJECTABLE;INTRAVENOUS | 021817-001 | Apr 16, 2007 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RECLAST
See the table below for patents covering RECLAST around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1827 | Substituted alkanediphosphonic acids | See Plans and Pricing |
China | 1272013 | See Plans and Pricing | |
South Korea | 960010752 | See Plans and Pricing | |
World Intellectual Property Organization (WIPO) | 0197788 | See Plans and Pricing | |
Tunisia | SN06084 | PHARMACEUTICAL PRODUCTS COMPRISING BISPHOSPHONATES | See Plans and Pricing |
South Africa | 8708698 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RECLAST
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1591122 | 2013C/022 | Belgium | See Plans and Pricing | PRODUCT NAME: ACIDE ZOLEDRONIQUE; AUTHORISATION NUMBER AND DATE: C(2007)4619 20071003 |
0275821 | 2001C/035 | Belgium | See Plans and Pricing | PRODUCT NAME: ACIDE ZOLEDRONIQUE; NAT. REGISTRATION NO/DATE: EU/1/01/176/001 20010321; FIRST REGISTRATION: CH 55463 20001128 |
0275821 | 01C0035 | France | See Plans and Pricing | PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128 |
0258618 | SPC/GB01/042 | United Kingdom | See Plans and Pricing | PRODUCT NAME: ZOLEDRONIC ACID 2-(IMIDAZOL-1-YL)-1-HYDROXYETHANE-1,1-DIPHOSPHONIC ACID; REGISTERED: CH 55463 20001128; UK EU/1/01/176/001 20010320; UK EU/1/01/176/002 20010320; UK EU/1/01/176/003 20010320 |
1591122 | 300582 | Netherlands | See Plans and Pricing | PRODUCT NAME: ZOLEDRONZUUR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, DAN WEL IEDER HYDRAAT DAARVAN; REGISTRATION NO/DATE: C(2007)4619 20071003 |
0275821 | C300058 | Netherlands | See Plans and Pricing | PRODUCT NAME: ZOLEDRONINEZUUR, DESGEWENST IN DE VORM VAN EEN ZOUT OF SOLVAAT, IN HET BIJZONDER ZOLEDRONINE-ZUUR-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/01/176/001-003 20010320 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |