NATEGLINIDE - Generic Drug Details
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What are the generic sources for nateglinide and what is the scope of patent protection?
Nateglinide
is the generic ingredient in two branded drugs marketed by Alvogen, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Rising, Strides Pharma, Teva Pharms, Watson Labs, Zydus Pharms, and Novartis, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for nateglinide. Eleven suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for NATEGLINIDE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 9 |
NDAs: | 9 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 128 |
Clinical Trials: | 24 |
Patent Applications: | 6,827 |
Drug Prices: | Drug price trends for NATEGLINIDE |
What excipients (inactive ingredients) are in NATEGLINIDE? | NATEGLINIDE excipients list |
DailyMed Link: | NATEGLINIDE at DailyMed |
Recent Clinical Trials for NATEGLINIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ministry of Health, Kuwait | Phase 4 |
Dasman Diabetes Institute | Phase 4 |
Kuwait University | Phase 4 |
Generic filers with tentative approvals for NATEGLINIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 120MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 60MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for NATEGLINIDE
Drug Class | Glinide |
Mechanism of Action | Potassium Channel Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for NATEGLINIDE
Paragraph IV (Patent) Challenges for NATEGLINIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
STARLIX | Tablets | nateglinide | 60 mg and 120 mg | 021204 | 2004-12-22 |
US Patents and Regulatory Information for NATEGLINIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alvogen | NATEGLINIDE | nateglinide | TABLET;ORAL | 205055-002 | Dec 11, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cadila Pharms Ltd | NATEGLINIDE | nateglinide | TABLET;ORAL | 206432-001 | Apr 19, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Watson Labs | NATEGLINIDE | nateglinide | TABLET;ORAL | 077462-002 | Mar 30, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dr Reddys Labs Ltd | NATEGLINIDE | nateglinide | TABLET;ORAL | 077461-002 | Sep 9, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cadila Pharms Ltd | NATEGLINIDE | nateglinide | TABLET;ORAL | 206432-002 | Apr 19, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novartis | STARLIX | nateglinide | TABLET;ORAL | 021204-002 | Dec 22, 2000 | DISCN | Yes | 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 NATEGLINIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | STARLIX | nateglinide | TABLET;ORAL | 021204-002 | Dec 22, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | STARLIX | nateglinide | TABLET;ORAL | 021204-001 | Dec 22, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | STARLIX | nateglinide | TABLET;ORAL | 021204-002 | Dec 22, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | STARLIX | nateglinide | TABLET;ORAL | 021204-002 | Dec 22, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | STARLIX | nateglinide | TABLET;ORAL | 021204-002 | Dec 22, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | STARLIX | nateglinide | TABLET;ORAL | 021204-001 | Dec 22, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for NATEGLINIDE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Novartis Europharm Limited | Starlix | nateglinide | EMEA/H/C/000335 Nateglinide is indicated for combination therapy with metformin in type-2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone. |
Withdrawn | no | no | no | 2001-04-03 | |
Novartis Europharm Ltd. | Trazec | nateglinide | EMEA/H/C/000383 Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone. |
Withdrawn | no | no | no | 2001-04-03 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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