Carbidopa; levodopa - Generic Drug Details
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What are the generic sources for carbidopa; levodopa and what is the scope of patent protection?
Carbidopa; levodopa
is the generic ingredient in eight branded drugs marketed by Impax Labs Inc, Abbvie, Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Sciegen Pharms Inc, Sun Pharm Inds, Organon Llc, Ranbaxy, Rising, Sun Pharm, Ucb Inc, Actavis Elizabeth, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Rubicon, SCS, Watson Labs, Zydus Pharms, Avion Pharms, and Organon, and is included in thirty-four NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Carbidopa; levodopa has thirty-two patent family members in thirteen countries.
Thirty-three suppliers are listed for this compound.
Summary for carbidopa; levodopa
International Patents: | 32 |
US Patents: | 11 |
Tradenames: | 8 |
Applicants: | 26 |
NDAs: | 34 |
Finished Product Suppliers / Packagers: | 33 |
Clinical Trials: | 183 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for carbidopa; levodopa |
DailyMed Link: | carbidopa; levodopa at DailyMed |
Recent Clinical Trials for carbidopa; levodopa
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bronx VA Medical Center | Phase 1 |
University of Minnesota | Early Phase 1 |
VistaGen Therapeutics, Inc. | Phase 2 |
Pharmacology for carbidopa; levodopa
Drug Class | Aromatic Amino Acid |
Anatomical Therapeutic Chemical (ATC) Classes for carbidopa; levodopa
Paragraph IV (Patent) Challenges for CARBIDOPA; LEVODOPA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
RYTARY | Extended-release Capsules | carbidopa; levodopa | 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg | 203312 | 1 | 2015-06-24 |
RYTARY | Extended-release Capsules | carbidopa; levodopa | 61.25 mg/245 mg | 203312 | 1 | 2015-06-10 |
US Patents and Regulatory Information for carbidopa; levodopa
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Scs | CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET;ORAL | 074080-001 | Mar 25, 1994 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Organon | SINEMET | carbidopa; levodopa | TABLET;ORAL | 017555-003 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-004 | Jan 7, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Impax Labs Inc | RYTARY | carbidopa; levodopa | CAPSULE, EXTENDED RELEASE;ORAL | 203312-003 | Jan 7, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Ranbaxy | CARBILEV | carbidopa; levodopa | TABLET, FOR SUSPENSION;ORAL | 076643-003 | Jun 10, 2005 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Impax Labs | CARBIDOPA AND LEVODOPA | carbidopa; levodopa | TABLET, ORALLY DISINTEGRATING;ORAL | 090631-003 | Jun 8, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Abbvie | DUOPA | carbidopa; levodopa | SUSPENSION;ENTERAL | 203952-001 | Jan 9, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 carbidopa; levodopa
EU/EMA Drug Approvals for carbidopa; levodopa
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Amneal Pharma Europe Ltd | Numient | levodopa, carbidopa | EMEA/H/C/002611 Symptomatic treatment of adult patients with Parkinson’s disease |
Withdrawn | no | no | no | 2015-11-19 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for carbidopa; levodopa
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 248520 | תערובות שחרור מבוקרות של levodopa ושמושיהן (Controlled release formulation of levodopa and uses thereof) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2009085306 | ⤷ Try a Trial | |
Japan | 2015187178 | レボドパの放出制御製剤及びその使用 (CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND USES THEREOF) | ⤷ Try a Trial |
China | 101910113 | Controlled release formulations of levodopa and uses thereof | ⤷ Try a Trial |
Japan | 6328205 | ⤷ Try a Trial | |
South Korea | 101451564 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2019191353 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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