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

See drug prices for NATEGLINIDE

Recent Clinical Trials for NATEGLINIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Dasman Diabetes Institute	Phase 4
Kuwait University	Phase 4
Texas Diabetes Institute	Phase 4

See all NATEGLINIDE clinical trials

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

A10BX	Other blood glucose lowering drugs, excl. insulins
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms	NATEGLINIDE	nateglinide	TABLET;ORAL	077467-001	Sep 9, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	STARLIX	nateglinide	TABLET;ORAL	021204-001	Dec 22, 2000		DISCN	Yes	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
Cadila Pharms Ltd	NATEGLINIDE	nateglinide	TABLET;ORAL	206432-002	Apr 19, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	NATEGLINIDE	nateglinide	TABLET;ORAL	205248-002	Jul 6, 2016	AB	RX	No	Yes	⤷ 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

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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	021204-002	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	021204-001	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

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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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