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Generated: August 18, 2017
What are the generic drug sources for diltiazem hydrochloride and what is the scope of diltiazem hydrochloride freedom to operate?
Diltiazem hydrochloride is the generic ingredient in eleven branded drugs marketed by Actavis Labs Fl Inc, Valeant Pharms North, Valeant Intl, Hospira, Mylan, Athenex Inc, Sun Pharma Global, Sandoz, Sun Pharm Inds Ltd, Biovail Labs Intl, West-ward Pharms Int, Biovail, Apotex, Intl Medication, Hikma Farmaceutica, Apothecon, Actavis Elizabeth, Nesher Pharms, Teva Pharms, Ivax Sub Teva Pharms, Mylan Labs Ltd, Teva, Par Pharm, Akorn Inc, Allergan Sales Llc, Chartwell Molecules, Teva Pharms Usa, and Apotex Inc, and is included in forty-six NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 11 |
| Patents: | 2 |
| Applicants: | 28 |
| NDAs: | 46 |
| Drug Master File Entries: see list | 26 |
| Suppliers / Packagers: see list | 45 |
| Bulk Api Vendors: see list | 50 |
| Clinical Trials: see list | 2,319 |
| Patent Applications: see list | 3,510 |
| Therapeutic Class: | Cardiovascular Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | diltiazem hydrochloride at DailyMed |
| Drug Class | Calcium Channel Blocker |
| Mechanism of Action | Calcium Channel Antagonists |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Valeant Intl | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-001 | Aug 10, 1992 | AB3 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Sun Pharma Global | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 090421-004 | Nov 15, 2010 | AB4 | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Biovail | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020939-006 | Sep 14, 2001 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Apotex Inc | DILTZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 076395-003 | Feb 1, 2006 | AB4 | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Ivax Sub Teva Pharms | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | TABLET;ORAL | 074168-003 | Mar 3, 1995 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Biovail | CARDIZEM SR | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 019471-003 | Jan 23, 1989 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Valeant Intl | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-001 | Aug 10, 1992 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Valeant Pharms North | TIAZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020401-006 | Oct 16, 1998 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Valeant Intl | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-002 | Dec 27, 1991 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Valeant Intl | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-005 | Aug 24, 1999 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 3725474 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2348953 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2325826 | ► Subscribe | |||||||||||||||||||||||||||
| United Kingdom | 9921933 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2241637 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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