Diltiazem hydrochloride - Generic Drug Details
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What are the generic sources for diltiazem hydrochloride and what is the scope of freedom to operate?
Diltiazem hydrochloride
is the generic ingredient in twelve branded drugs marketed by Bausch, Biovail, Actavis Labs Fl Inc, Allergan, Apotex, Accord Hlthcare, Actavis Elizabeth, Amta, Glenmark Pharms Ltd, Mayne Pharma Intl, Mylan, Nesher Pharms, Novast Labs, Par Pharm, Sandoz, Sun Pharm, Teva, Twi Pharms, Valeant Pharms North, Zydus Pharms, Biovail Labs Intl, Akorn, Athenex Inc, Dr Reddys, Hikma Farmaceutica, Hospira, Intl Medication, Mylan Labs Ltd, West-ward Pharms Int, Exela Pharma, Apothecon, Chartwell Molecules, Edenbridge Pharms, Ivax Sub Teva Pharms, Rising, Sciegen Pharms Inc, and Teva Pharms, and is included in fifty-eight NDAs. Additional information is available in the individual branded drug profile pages.There are seventeen drug master file entries for diltiazem hydrochloride. Forty-five suppliers are listed for this compound.
Summary for diltiazem hydrochloride
US Patents: | 0 |
Tradenames: | 12 |
Applicants: | 37 |
NDAs: | 58 |
Drug Master File Entries: | 17 |
Finished Product Suppliers / Packagers: | 45 |
Raw Ingredient (Bulk) Api Vendors: | 120 |
Clinical Trials: | 106 |
Patent Applications: | 4,291 |
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 |
---|---|
Ascension Genesys Hospital | Phase 2 |
Aurora Health Care | Phase 4 |
Signia Therapeutics | Phase 2 |
Pharmacology for diltiazem hydrochloride
Drug Class | Calcium Channel Blocker |
Mechanism of Action | Calcium Channel Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for diltiazem hydrochloride
Paragraph IV (Patent) Challenges for DILTIAZEM HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
CARDIZEM LA | Extended-release Tablets | diltiazem hydrochloride | 120 mg, 180 mg, 240 mg, 300 mg and 360 mg | 021392 | 1 | 2005-08-30 |
CARDIZEM LA | Extended-release Tablets | diltiazem hydrochloride | 420 mg | 021392 | 1 | 2005-04-25 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glenmark Pharms Ltd | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 212317-003 | Mar 22, 2021 | AB1 | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Bausch | CARDIZEM LA | diltiazem hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021392-004 | Feb 6, 2003 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Accord Hlthcare | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206997-001 | Apr 28, 2020 | AB2 | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Valeant Pharms North | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 075116-002 | Dec 23, 1999 | AB3 | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 |
---|---|---|---|---|---|---|---|
Allergan | DILACOR XR | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020092-002 | May 29, 1992 | See Plans and Pricing | See Plans and Pricing |
Biovail | DILTIAZEM HYDROCHLORIDE | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020939-003 | Jan 28, 2000 | See Plans and Pricing | See Plans and Pricing |
Bausch | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-002 | Dec 27, 1991 | See Plans and Pricing | See Plans and Pricing |
Bausch | CARDIZEM CD | diltiazem hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 020062-004 | Dec 27, 1991 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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