PENICILLAMINE Drug Patent Profile
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Which patents cover Penicillamine, and what generic alternatives are available?
Penicillamine is a drug marketed by Ani Pharms, Apotex, Breckenridge, Dr Reddys, Granules, Invagen Pharms, Navinta Llc, Par Pharm Inc, Watson Labs Inc, Lupin Ltd, and Teva Pharms Usa. and is included in twelve NDAs.
The generic ingredient in PENICILLAMINE is penicillamine. There are eighteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the penicillamine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Penicillamine
A generic version of PENICILLAMINE was approved as penicillamine by ANI PHARMS on May 7th, 2019.
Summary for PENICILLAMINE
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 12 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 105 |
| Clinical Trials: | 16 |
| Patent Applications: | 3,955 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PENICILLAMINE |
| What excipients (inactive ingredients) are in PENICILLAMINE? | PENICILLAMINE excipients list |
| DailyMed Link: | PENICILLAMINE at DailyMed |
Recent Clinical Trials for PENICILLAMINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Alexion Pharmaceuticals | Phase 2 |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Early Phase 1 |
| GMP-Orphan SAS | Phase 3 |
Pharmacology for PENICILLAMINE
| Drug Class | Antirheumatic Agent |
Medical Subject Heading (MeSH) Categories for PENICILLAMINE
Anatomical Therapeutic Chemical (ATC) Classes for PENICILLAMINE
US Patents and Regulatory Information for PENICILLAMINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | PENICILLAMINE | penicillamine | CAPSULE;ORAL | 209921-001 | May 7, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Navinta Llc | PENICILLAMINE | penicillamine | CAPSULE;ORAL | 214363-001 | Oct 8, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Dr Reddys | PENICILLAMINE | penicillamine | CAPSULE;ORAL | 211867-001 | Aug 4, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms Usa | PENICILLAMINE | penicillamine | TABLET;ORAL | 211497-001 | Feb 13, 2020 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Par Pharm Inc | PENICILLAMINE | penicillamine | CAPSULE;ORAL | 211231-001 | Dec 23, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Apotex | PENICILLAMINE | penicillamine | CAPSULE;ORAL | 213310-001 | Apr 28, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
