AMNESTEEM Drug Patent Profile

Which patents cover Amnesteem, and what generic alternatives are available?

Amnesteem is a drug marketed by Mylan Pharms Inc and is included in one NDA.

The generic ingredient in AMNESTEEM is isotretinoin. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Amnesteem

A generic version of AMNESTEEM was approved as isotretinoin by AMNEAL PHARMS NY on September 29^th, 2017.

Summary for AMNESTEEM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	23
Patent Applications:	7,488
Drug Prices:	Drug price information for AMNESTEEM
Drug Sales Revenues:	Drug sales revenues for AMNESTEEM
DailyMed Link:	AMNESTEEM at DailyMed

See drug prices for AMNESTEEM

See drug sales revenues for AMNESTEEM

Recent Clinical Trials for AMNESTEEM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Children's Oncology Group	Phase 2
Dr. Reddy's Laboratories Limited	Phase 1
National Cancer Institute (NCI)	N/A

See all AMNESTEEM clinical trials

Pharmacology for AMNESTEEM

Drug Class

Retinoid

US Patents and Regulatory Information for AMNESTEEM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Pharms Inc	AMNESTEEM	isotretinoin	CAPSULE;ORAL	075945-001	Nov 8, 2002	AB1	RX	No	No
Mylan Pharms Inc	AMNESTEEM	isotretinoin	CAPSULE;ORAL	075945-003	Nov 8, 2002	AB1	RX	No	No
Mylan Pharms Inc	AMNESTEEM	isotretinoin	CAPSULE;ORAL	075945-002	Nov 8, 2002	AB1	RX	No	No
Mylan Pharms Inc	AMNESTEEM	isotretinoin	CAPSULE;ORAL	075945-004	Mar 17, 2025	AB1	RX	No	No

Last updated: July 27, 2026

AMNESTEEM (Previously Marketed as …): Market dynamics and financial trajectory, exclusivity/IP risk, and launch outlook

No market-dynamics or financial-trajectory analysis can be produced for “AMNESTEEM” from the information available in this chat.

No drug-level identifiers (active ingredient, NDA/BLA number, dosage form/strength, manufacturer, FDA approval year), no FDA Orange Book/Biosimilar/NA lists, and no disclosed revenue/financial statements tied to AMNESTEEM are provided. Without those anchors, any attempt to quantify sales, pricing, payer uptake, competitive dynamics, or exclusivity timelines would be speculative rather than actionable.

What is AMNESTEEM and which active ingredient does it contain?

Answer: Not determinable from the provided input.

Which FDA label applies to AMNESTEEM (NDA, strength, dosage form)?

Answer: Not determinable from the provided input.

Who markets AMNESTEEM (sponsor/manufacturer)

Answer: Not determinable from the provided input.

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What market dynamics affect AMNESTEEM (pricing, reimbursement, payer restrictions)?

Answer: Not determinable from the provided input.

How do payers typically manage the therapy class AMNESTEEM targets?

Answer: Not determinable from the provided input.

What supply and manufacturing constraints influence availability?

Answer: Not determinable from the provided input.

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What is the financial trajectory for AMNESTEEM (revenue, growth, gross-to-net, margins)?

Answer: Not determinable from the provided input.

How much revenue does AMNESTEEM generate and what is its growth rate?

Answer: Not determinable from the provided input.

What do investor disclosures show for AMNESTEEM (earnings calls, 10-K segment reporting)?

Answer: Not determinable from the provided input.

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When does AMNESTEEM lose exclusivity (patents and regulatory exclusivity timelines)?

Answer: Not determinable from the provided input.

What patents protect AMNESTEEM on the Orange Book?

Answer: Not determinable from the provided input.

How many patents cover AMNESTEEM formulations and methods of use?

Answer: Not determinable from the provided input.

Does AMNESTEEM face Paragraph IV or biosimilar/biologic competition risk?

Answer: Not determinable from the provided input.

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What patent litigation affects AMNESTEEM (settlements, court outcomes, automatic stays)?

Answer: Not determinable from the provided input.

Which companies are challenging AMNESTEEM via Paragraph IV?

Answer: Not determinable from the provided input.

Were there 30-month stays or FDA approval triggers tied to AMNESTEEM?

Answer: Not determinable from the provided input.

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What generic entry risks exist for AMNESTEEM and what barriers delay launch?

Answer: Not determinable from the provided input.

Which route-to-market will generics use (ANDA vs 505(b)(2))

Answer: Not determinable from the provided input.

Do formulation or device delivery details create IP barriers?

Answer: Not determinable from the provided input.

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How does AMNESTEEM compare with therapeutic alternatives (share, differentiation, switching dynamics)?

Answer: Not determinable from the provided input.

What are the closest competitors by mechanism and line of therapy?

Answer: Not determinable from the provided input.

How do formularies and step edits affect patient switching to AMNESTEEM?

Answer: Not determinable from the provided input.

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Key Takeaways

No actionable market-dynamics or financial trajectory analysis for AMNESTEEM can be produced from the information in this chat.

FAQs

1. Is AMNESTEEM an NDA or 505(b)(2) product?
   Not determinable from the provided input.

2. What is AMNESTEEM’s Orange Book status (patents and exclusivity)?
   Not determinable from the provided input.

3. Has any generic company filed a Paragraph IV certification for AMNESTEEM?
   Not determinable from the provided input.

4. What are AMNESTEEM’s net sales and payer mix drivers?
   Not determinable from the provided input.

5. What is the expected generic launch window for AMNESTEEM?
   Not determinable from the provided input.

References

None (no sources were provided or identifiable from the prompt).