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Diltiazem hydrochloride - Generic Drug Details
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What are the generic sources for diltiazem hydrochloride and what is the scope of patent protection?
Diltiazem hydrochloride
is the generic ingredient in eleven branded drugs marketed by Bausch, Biovail, Actavis Labs Fl Inc, Allergan, Apotex, Accord Hlthcare, Actavis Elizabeth, Mylan, Nesher Pharms, Novast Labs, Par Pharm, Sandoz, Sun Pharm, Teva, Twi Pharms, Valeant Pharms North, Zydus Pharms, Biovail Labs Intl, Akorn Inc, Athenex Inc, Dr Reddys, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, West-ward Pharms Int, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, and Teva Pharms, and is included in fifty-three NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Diltiazem hydrochloride has twelve patent family members in eleven countries.
There are twenty-six drug master file entries for diltiazem hydrochloride. Thirty-seven suppliers are listed for this compound.
Summary for diltiazem hydrochloride
| International Patents: | 12 |
| US Patents: | 1 |
| Tradenames: | 11 |
| Applicants: | 31 |
| NDAs: | 53 |
| Drug Master File Entries: | 26 |
| Suppliers / Packagers: | 37 |
| Bulk Api Vendors: | 101 |
| Clinical Trials: | 94 |
| Patent Applications: | 4,012 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for diltiazem hydrochloride |
| What excipients (inactive ingredients) are in diltiazem hydrochloride? | diltiazem hydrochloride excipients list |
| DailyMed Link: | diltiazem hydrochloride at DailyMed |
Recent Clinical Trials for diltiazem hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute, Egypt | Early Phase 1 |
| BeiGene | Phase 1 |
| University of Auckland, New Zealand | Phase 2/Phase 3 |
Pharmacology for diltiazem hydrochloride
| Drug Class | Calcium Channel Blocker |
| Mechanism of Action | Calcium Channel Antagonists |
Paragraph IV (Patent) Challenges for DILTIAZEM HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CARDIZEM LA | TABLET, EXTENDED RELEASE;ORAL | diltiazem hydrochloride | 021392 | 2005-08-30 |
| CARDIZEM LA | TABLET, EXTENDED RELEASE;ORAL | diltiazem hydrochloride | 021392 | 2005-04-25 |
| CARDIZEM CD | CAPSULE, EXTENDED RELEASE;ORAL | diltiazem hydrochloride | 020062 | |
| DILACOR XR | CAPSULE, EXTENDED RELEASE;ORAL | diltiazem hydrochloride | 020092 | |
| TIAZAC | CAPSULE, EXTENDED RELEASE;ORAL | diltiazem hydrochloride | 020401 | |
| CARDIZEM SR | CAPSULE, EXTENDED RELEASE;ORAL | diltiazem hydrochloride | 019471 |
US Patents and Regulatory Information for diltiazem hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nesher Pharms | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 076563-003 | Sep 12, 2006 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| West-ward Pharms Int | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | INJECTABLE;INJECTION | 078538-001 | Dec 17, 2008 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Hospira | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | INJECTABLE;INJECTION | 075106-001 | Apr 29, 1999 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Bausch | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-006 | Feb 6, 2003 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| >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 diltiazem hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-006 | Feb 6, 2003 | Start Trial | Start Trial |
| Bausch | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-001 | Feb 6, 2003 | Start Trial | Start Trial |
| Bausch | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-005 | Aug 24, 1999 | Start Trial | Start Trial |
| Bausch | TIAZAC | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020401-005 | Sep 11, 1995 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for diltiazem hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 3725474 | Start Trial |
| Australia | 6566700 | Start Trial |
| Spain | 2241637 | Start Trial |
| United Kingdom | 9921933 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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 verification 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.
ISSN: 2162-2639
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