Quinine sulfate - Generic Drug Details
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What are the generic drug sources for quinine sulfate and what is the scope of patent protection?
Quinine sulfate
is the generic ingredient in two branded drugs marketed by Sun Pharm Industries, Amneal Pharms, Aurobindo Pharma Usa, Lupin Ltd, Novast Labs, and Teva Pharms, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.There are six drug master file entries for quinine sulfate. Five suppliers are listed for this compound.
Summary for quinine sulfate
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 6 |
NDAs: | 6 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 205 |
Clinical Trials: | 17 |
Patent Applications: | 4,860 |
Drug Prices: | Drug price trends for quinine sulfate |
What excipients (inactive ingredients) are in quinine sulfate? | quinine sulfate excipients list |
DailyMed Link: | quinine sulfate at DailyMed |
Recent Clinical Trials for quinine sulfate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hiroshi Mitsumoto | Phase 1/Phase 2 |
Universitas Padjadjaran | N/A |
Prodia Diacro Laboratories P.T. | N/A |
Pharmacology for quinine sulfate
Drug Class | Antimalarial |
Medical Subject Heading (MeSH) Categories for quinine sulfate
Anatomical Therapeutic Chemical (ATC) Classes for quinine sulfate
US Patents and Regulatory Information for quinine sulfate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm Industries | QUALAQUIN | quinine sulfate | CAPSULE;ORAL | 021799-001 | Aug 12, 2005 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novast Labs | QUININE SULFATE | quinine sulfate | CAPSULE;ORAL | 204372-001 | Jul 22, 2015 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lupin Ltd | QUININE SULFATE | quinine sulfate | CAPSULE;ORAL | 203112-001 | Apr 24, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma Usa | QUININE SULFATE | quinine sulfate | CAPSULE;ORAL | 202581-001 | Dec 14, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Amneal Pharms | QUININE SULFATE | quinine sulfate | CAPSULE;ORAL | 203729-001 | Jul 15, 2015 | 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 |
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