NATEGLINIDE Drug Patent Profile
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Which patents cover Nateglinide, and when can generic versions of Nateglinide launch?
Nateglinide is a drug marketed by Alvogen, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Rising, Strides Pharma, Teva Pharms, Watson Labs, and Zydus Pharms. and is included in eight NDAs.
The generic ingredient in NATEGLINIDE is nateglinide. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the nateglinide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nateglinide
A generic version of NATEGLINIDE was approved as nateglinide by DR REDDYS LABS LTD on September 9th, 2009.
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Questions you can ask:
- What is the 5 year forecast for NATEGLINIDE?
- What are the global sales for NATEGLINIDE?
- What is Average Wholesale Price for NATEGLINIDE?
Summary for NATEGLINIDE
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 128 |
| Clinical Trials: | 24 |
| Patent Applications: | 4,159 |
| Drug Prices: | Drug price information for NATEGLINIDE |
| 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 |
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 | 205055-001 | Dec 11, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | NATEGLINIDE | nateglinide | TABLET;ORAL | 205544-001 | Jun 18, 2018 | 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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 |
