THEOPHYLLINE Drug Patent Profile
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Which patents cover Theophylline, and what generic alternatives are available?
Theophylline is a drug marketed by Cent Pharms, Hospira, Inwood Labs, Sandoz, Kv Pharm, Scherer Rp, Alpharma Us Pharms, Cenci, Chartwell Rx, Halsey, Pharm Assoc, Precision Dose, Roxane, Sun Pharma Canada, Wockhardt, Chartwell Molecular, Tris Pharma Inc, Able, Ajanta Pharma Ltd, Alembic, Amneal, Annora Pharma, Bionpharma, Glenmark Pharms Ltd, Harman Finochem, Heritage Pharma Avet, Mpp Pharma, Nostrum Pharms Llc, Rhodes Pharms, Strides Pharma, Teva Pharms Inc, Velzen Pharma Pvt, Zydus Lifesciences, B Braun, Baxter Hlthcare, and Hospira Inc. and is included in fifty-five NDAs.
The generic ingredient in THEOPHYLLINE is theophylline. There are thirty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the theophylline profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Theophylline
A generic version of THEOPHYLLINE was approved as theophylline by RHODES PHARMS on September 1st, 1982.
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Questions you can ask:
- What is the 5 year forecast for THEOPHYLLINE?
- What are the global sales for THEOPHYLLINE?
- What is Average Wholesale Price for THEOPHYLLINE?
Summary for THEOPHYLLINE
| US Patents: | 0 |
| Applicants: | 36 |
| NDAs: | 55 |
| Finished Product Suppliers / Packagers: | 24 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 122 |
| Patent Applications: | 3,330 |
| Drug Prices: | Drug price information for THEOPHYLLINE |
| DailyMed Link: | THEOPHYLLINE at DailyMed |
Recent Clinical Trials for THEOPHYLLINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Nebraska | PHASE1 |
| Minia University | EARLY_PHASE1 |
| Assiut University | PHASE1 |
Pharmacology for THEOPHYLLINE
| Drug Class | Methylxanthine |
Medical Subject Heading (MeSH) Categories for THEOPHYLLINE
Anatomical Therapeutic Chemical (ATC) Classes for THEOPHYLLINE
US Patents and Regulatory Information for THEOPHYLLINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Lifesciences | THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 218063-002 | May 21, 2024 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Annora Pharma | THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 217422-001 | Sep 8, 2023 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Able | THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 040543-001 | Apr 27, 2004 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Baxter Hlthcare | THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER | theophylline | INJECTABLE;INJECTION | 018649-001 | Jul 26, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Harman Finochem | THEOPHYLLINE | theophylline | TABLET, EXTENDED RELEASE;ORAL | 214806-001 | Oct 24, 2023 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
