AMLODIPINE BESYLATE - Generic Drug Details

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What are the generic sources for amlodipine besylate and what is the scope of freedom to operate?

Amlodipine besylate is the generic ingredient in nineteen branded drugs marketed by Cmp Dev Llc, Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Aurobindo Pharma, Chartwell Rx, China Resources, Cipla, Corepharma, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mylan, Norvium Bioscience, Orbion Pharms, Oxford Pharms, Polygen Pharms, Puracap Pharm, Sciegen Pharms Inc, Sovereign Pharms, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine, Teva, Torrent Pharms, Unichem, Watson Labs, Wockhardt, Zydus Pharms Usa, Viatris, Apotex, Dr Reddys, Zydus Pharms, Pharmacia, Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Teva Pharms, Watson Labs Inc, Sandoz, Purple Biotech, Endo Operations, Teva Pharms Usa, Torrent, Cosette, Lupin Ltd, Novartis, Accord Hlthcare Inc, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Micro Labs, Adhera, Boehringer Ingelheim, Hetero Labs, and Novel Labs Inc, and is included in one hundred NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for amlodipine besylate. Forty-seven suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for AMLODIPINE BESYLATE

US Patents:	10
Tradenames:	19
Applicants:	68
NDAs:	100
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	58
Patent Applications:	7,057
Drug Prices:	Drug price trends for AMLODIPINE BESYLATE
Drug Sales Revenues:	Drug sales revenues for AMLODIPINE BESYLATE
What excipients (inactive ingredients) are in AMLODIPINE BESYLATE?	AMLODIPINE BESYLATE excipients list
DailyMed Link:	AMLODIPINE BESYLATE at DailyMed

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Drug Sales Revenue Trends for AMLODIPINE BESYLATE

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Recent Clinical Trials for AMLODIPINE BESYLATE

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

Sponsor	Phase
Overseas Pharmaceuticals, Ltd.	Phase 1
Guangzhou Health Start Pharmaceutical Techology Co.,Ltd	Phase 1
National Heart, Lung, and Blood Institute (NHLBI)	Phase 4

See all AMLODIPINE BESYLATE clinical trials

Generic filers with tentative approvals for AMLODIPINE BESYLATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 10MG BASE	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 5MG BASE	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 2.5MG BASE	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 AMLODIPINE BESYLATE

Drug Class	Dihydropyridine Calcium Channel Blocker Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BESYLATE

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

US Patents and Regulatory Information for AMLODIPINE BESYLATE

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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
Lupin Ltd	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	200797-001	Jun 3, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Torrent	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	203580-002	Oct 26, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ajanta Pharma Ltd	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	207216-001	Oct 28, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-001	May 31, 2018		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Strides Pharma	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	201087-001	Jun 1, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Corepharma	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	076719-003	May 23, 2007	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

Expired US Patents for AMLODIPINE BESYLATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-002	Jul 31, 1992	⤷ Sign Up	⤷ Sign Up
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-001	Sep 27, 2007	⤷ Sign Up	⤷ Sign Up
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-001	Jul 31, 1992	⤷ Sign Up	⤷ Sign Up
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-002	Jul 31, 1992	⤷ Sign Up	⤷ Sign Up
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-003	Sep 27, 2007	⤷ Sign Up	⤷ Sign Up
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-003	Jul 31, 1992	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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